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Michael Stomberg brings a wealth of organizational design and strategic leadership experience to ProPharma. He has held the role of CEO within multiple companies including several in the biopharmaceutical, healthcare, technology, and energy industries.
After founding his first company at age 26, an IT consulting company focused on technology solutions for the life sciences industry, he quickly expanded the company into the go-to consulting and human capital solutions provider to emerging life science companies. Following a successful exit, Michael launched The Planet Group in 2009, a leading global provider of specialized consulting services and outsourced human capital solutions focused on the life sciences, energy, and technology sectors.
As CEO, Michael led The Planet Group to record organic growth and global expansion while also leading the company through the launch of four new business lines and the acquisition of multiple firms. He also led the M&A activities when in May 2021, The Planet Group merged with ProPharma. Michael assumed the role of ProPharma’s CEO in September 2021.
Known for continually innovating and scaling businesses for the betterment of employees and clients alike, Michael is dedicated to quality, high-level subject matter expertise, operational efficiency, customized solutions, and world-class customer service.
His expertise includes organizational design & development, leadership development, streamlining operations, technology integration, and global business strategy. Michael holds a Bachelor’s degree from Northern Illinois University and an MBA from the Keller Graduate School of Management.
Jason DeGoes brings over 25 years of industry experience and leadership to his role as President of ProPharma. Through his prior role as COO of ProPharma, Jason empowered comprehensive solutions in support of improving patient health and safety. Over his career, Jason has demonstrated his ability to lead global patient service operations of more than 2000 professionals and his forte for implementing Specialty Pharmacy services in the global marketplace. Jason has held roles such as Senior Vice President Global Patient Solutions, and Vice President of Market Strategy and Development for large healthcare organizations including Teva Pharmaceuticals, Medco Health Solutions, Vion Pharmaceuticals, and Alpha Therapeutic Corporation. He has also served as a consultant to the pharmaceutical industry in both North America and Europe.
Jason completed his undergraduate studies in History and Political Science at Rhode Island College, and he has served as a member of several patient outcome-related committees within PhRMA, EFPIA, and Medicines for Europe.
As ProPharma’s CFO, Karl is responsible for leading the company’s finance functional areas, including financial planning and analysis, accounting, and treasury operations. As a member of ProPharma’s Executive Leadership Team, Karl is also responsible for driving ProPharma’s strategic business initiatives and accelerated growth plans.
With over 20 years of progressive finance leadership experience within the Pharma Services and Drug Development industry, Karl has held a number of executive leadership positions with leading life sciences organizations, where he successfully drove global scale through process improvement and implementation, systems integration, and strategy development. He also supported transformative organic and inorganic growth while instituting financial disciplines and operational excellence across the broader enterprise. Before entering the life sciences industry, Karl began his career working for a leading accounting firm, serving clients throughout the United States and internationally.
A life-long learner, Karl earned a Bachelor of Science in Accounting from the University of North Carolina – Wilmington in Wilmington, NC and a Master of Science in Accounting from East Carolina University in Greenville, NC.
As Chief Operating Officer at ProPharma, Carolyn Durham is responsible for the global operations of the company. Carolyn brings over 19 years of operational excellence to ProPharma and has a deep knowledge of multi-level organizational structures, having helped lead both Fortune 500 companies and startups to success. Her experience and leadership have been focused on developing and driving operational efficiencies on a global scale, providing strategies and incentives to accelerate revenue growth and implementing technology-driven business services.
During her career, she has overseen the integration activities of six M&As and worked closely with private equity firms and investors. She’s an expert at scaling businesses, evaluating, modifying and streamlining processes and standardizing procedures.
Carolyn was previously COO at The Planet Group, a global workforce solutions and professional services organization with which ProPharma merged in May 2021. Throughout her career her experience has encompassed sales, recruitment, business development, commercial operations and project management – primarily focused in the life sciences sector. Prior to Planet, she was with Delta Pharma, which was acquired by Randstad Life Sciences and Kelly Services.
Carolyn has a Bachelor’s degree in communication and culture with a minor in business and sociology from Indiana University in Bloomington, IN.
Bryan Katz joined ProPharma in 2022 as Chief Strategy Officer / Head of Corporate Development. In his role, Bryan provides leadership and oversight for the organization’s strategic planning endeavors, emphasizing future-focused solutions development and M&A initiatives. Bryan’s leadership and guidance in these areas ensures ProPharma remains at the forefront of industry innovation and growth.
Throughout his distinguished career, Bryan has held a number of progressive leadership roles with world-class organizations, including Abbott, PwC, Quintiles, and Syneos Health, where he served as Senior Vice President of Global Solution Development.
Known as a positive and impactful disruptor, Bryan is recognized for his ambition and visionary insights, driving transformative change throughout organizations and across the broader life sciences industry. Bryan’s contributions have left lasting impacts within healthcare, pharmaceutical, medical device, diagnostic, and Contract Research Organizations (CRO) sectors. In acknowledgement of his exceptional expertise and contributions, Bryan was honored in PM360’s ELITE 100 in 2020.
Committed to improving the health and safety of patients worldwide, Bryan is frequently invited to share his extensive knowledge at speaking events, serve as an expert panelist at symposiums and seminars, and contribute commentary and interviews to esteemed publications.
Joe Donnici joined ProPharma in August 2019 as Chief Information Officer and has over 20 years of IT and Leadership experience working globally in the Pharma services industry
As Vice President of Core IT at Quintiles, he successfully led enterprise deployments, managed business critical 24 X 7 operations departments, and designed and structured the IT organization to enable the company to scale effectively. Joe was ultimately responsible for Clinical, Corporate, and Commercial IT solutions as well as IT Operations, IT Security, and Service Management with a team of more than 500 employees and contractors globally
Joe also spent four years at Asahi Kasei Pharma America where he was responsible for IT Clinical and Patient Recruitment Solutions. While there, Joe developed and deployed a mobile-based solution for investigators and further improved insight and analysis capabilities by leveraging clinical data, patient screening data, and investigator data
Joe earned his BS in Business Administration and Computer Science from the University of Kansas.
Rachel Bias cultivates a workplace our colleagues can be proud of. She manages all aspects of the firm’s HR strategy and provides HR leadership to the company through the development and implementation of human resources policies, programs, and best practices.
With over 15 years of experience in Human Resources management, Rachel has held various leadership positions in both the private and public sectors. She provides knowledge in global legal compliance, employee benefits, employee relations, employment practices and procedures, employee communications, and she spearheads employee events and moral.
Rachel has a BA. in Business Administration from Campbell University and is a member of SHRM. She has presented a variety of employee development, recruiting, and retention seminars and served on multiple panels for many organizations and groups, including the University of Kansas, Kansas State University, and the Greater Kansas City Chamber of Commerce.
Sara Sorrentino has 15 years of experience blended between academic research, B2B sales, and spent the last ten years focused on business development and account management within the life sciences industry, specifically focused on the global outsourcing and CRO space.
As ProPharma’s EVP of Global Business Development, Sara partners with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges with innovative, creative, and efficient solutions. She also serves as a Subject Matter Expert in the areas of Clinical Research. Previously, Sara was a Senior Vice President of Treximo, a global consulting services provider to the life science industry. ProPharma merged with Treximo’s parent company, The Planet Group in May 2021.
Sara has expertise managing the full lifecycle of client development and expert knowledge in global outsourcing, vendor management, full-service, FSP, and blended service offerings across various functional areas and service lines. Sara specializes in developing flexible and consultative models for all of our client’s needs. She holds a Bachelor of Arts degree in Psychology and a minor in Communications from DePaul University in Chicago.
Tim Bauwens serves as the Senior Advisor to the CEO with responsibility for overseeing ProPharma’s high level strategic and financial initiatives and projects. Prior to his current role as Senior Advisor to the CEO, Tim served as ProPharma’s Chief Financial Officer.
Previously, he was CFO of The Planet Group, a leading global provider of specialized consulting services, and outsourced human capital solutions to the Life Sciences, Energy / Engineering and Technology sectors with which ProPharma merged in May 2021. Tim co-founded Planet in 2009 and helped lead it to become one of the fastest-growing companies in the U.S. He also was instrumental in scaling the organization and expanding its capabilities globally. During his tenure, Tim oversaw unprecedented organic growth as well as the financial, legal and compliance aspects of seven acquisitions in three years
Tim has over 30 years of corporate accounting and finance experience, having spent the early part of his career focused on mergers, acquisitions, and the subsequent integration of acquired companies, mostly in the service and utilities sectors. His depth of knowledge has helped the organizations he’s led continually partner with the right private equity firms and investors. Before founding The Planet Group, Tim spent several years in the professional services and life science industries working with publicly traded and privately held companies with an emphasis on accelerated topline growth, improved cash flow, integrating legacy systems, and maximizing return on investment. Earlier in his career he was a Controller at Exelon and CFO of Delta Pharma.
Matthew Weinberg leads Regulatory Sciences, focusing on client management, client satisfaction and strategic growth. The group helps clients clear regulatory hurdles as they develop and market drugs, biologics, and medical devices.
As CEO of The Weinberg Group, until its acquisition by ProPharma in 2019, Matthew was responsible for the growth and success of the firm – driving strategic expansion plans, acquisitions, and personnel development. He led the firm in its expansion into non-US markets and into aligned market segments such as GxP auditing.
Matthew created and chaired Building STEPS, a non-profit organization providing inner city children an opportunity to go to college and explore career opportunities in science. He has served on numerous Jewish community boards and is a fellow of the Wexner Heritage Foundation.
He has a BS and MS, Industrial Administration from the Tepper School of Business at Carnegie-Mellon University. Matthew spends his spare time training for and completing triathlons and traveling with his family, who still love him even though he never got them a dog.
With over 20 years of experience in the pharmaceutical and biotechnology industry Jim Kolbet helps clients overcome challenges
In 2003, Jim became the second full-time employee of ProPharma where he assumed a diverse array of responsibilities ranging from accounting, project management, sales, and marketing
In 2017 he led ProPharma’s Compliance and Quality Assurance business units to achieving the goal of unifying all service offerings to enhance the value delivered to our clients
Jim has since focused on building ProPharma’s Life Science Consulting global team which focuses on supporting client needs in the areas of Program and Project Management, Technology Transfers, and CMO outsourcing
Jim earned both his BS in Biology and MBA from the Iowa State University.
Matt Dube is a seasoned IT/IS leader with extensive operations, services, and business development expertise garnered over the past 20+ years across a broad range of pharmaceutical and life science sectors. Leveraging a fantastic mix of vendor software and R&D Informatics service provider expertise. Matt joined ProPharma to drive the growth and expansion of the R&D Technology Solutions practice. He has broad experience in developing strategic technological solutions in order to solve scientific problems in both large and small pharma and biotech organizations. Paired with a charismatic leadership style and a goal-oriented philosophy, Matt has built successful and technologically forward-thinking departments at each of the organizations he’s been a part of. Matt’s focus is to build out a world class R&D Technology organization that will provide cross value to all of ProPharma’s current and future clients ranging from preclinical systems through data science solutions.
Matt has his Master’s in Clinical Lab Science from UMass, and his BS in Microbiology and worked in a number of research positions early in his career, prior to focusing full time on IT and Informatics solutions in BioTech and Pharma.
Kevin Wysocki has 19 years of experience delivering projects for the pharmaceutical/biotechnology/medical device industries and leading consulting organizations. He began his consulting career in 2002 while working for a niche management consulting firm setting up PMOs and leading large change initiatives for some of the world’s most well-known bio/pharmaceuticals. It was during those engagements that he began developing strong leadership and organizational development skills. In 2011, Kevin assumed more of a leadership and management role with the consulting firm, in addition to the client delivery role. As one of the firm’s leaders, he assumed a diverse array of responsibilities ranging from client delivery, business development, marketing, and organizational development.
Most recently, Kevin has focused on building and integrating Treximo, a global consulting and outsourcing company focused on small/mid-sized bio/pharmaceuticals and medical device and diagnostic companies that became the Clinical Research Solutions arm of ProPharma in September 2021. Under Kevin’s leadership, Treximo became known within the life sciences industry for their exceptional customer service and functional experts who delivered services ranging from remediation and validation/qualification to a full suite of clinical research solutions and project and program management.
With ProPharma, Kevin will lead the Clinical Research Solutions Service Line with a primary focus of delivering a full suite of clinical consulting and outsourcing services.
He earned his BS in Biology from Truman State University and an MBA from Lake Forest Graduate School of Management.
As the Global President, Pharmacovigilance for ProPharma, Laura is responsible for leading the strategic management, planning, and execution of the Pharmacovigilance and Drug Safety function within the organization.
Laura brings over 20 years of safety and pharmacovigilance experience, with a focus on operations, strategy, and management. Laura most recently served as Vice President of Safety Management for Synteract (now Syneos Health), a leading full service CRO. In that role, Laura was responsible for commercial and operational leadership, cross-functional and cross-service business plan execution at the strategic and tactical levels, and supporting the integration of the organization following Synteract’s acquisition by Syneos Health. Prior to Synteract, Laura spent time at Quintiles and Health Information Alliance, and was a Primary Nurse practicing in Oncology and Bone Marrow Transplant for eleven years. Laura holds a BS in Nursing from Duke University.
With ProPharma, Laura will provide leadership and expert consultation on the design, development, and implementation of process and programs related to Global Pharmacovigilance.
Rajul has worked more than 17 years within the Pharmaceutical industry at various global leadership positions within Medical Information, Pharmacovigilance, Technology, and Program Management functions.
Prior to becoming President of Medical Information at ProPharma, Rajul was Head of North America Medical Information operations at IQVIA in United States, overseeing a large customer portfolio and managing a large global team. In this role, she managed significant expansion of Medical Information business and global footprint. Previously, she led Technology Solutions group at IQVIA which enabled implementation of innovative technology & automation solutions for Medical Information and Pharmacovigilance.
Before joining IQVIA, Rajul held several leadership roles in Business Development, Consulting and Business Analysis functions with a focus on Healthcare & Pharmaceuticals at IBM, Cognizant and Infosys BPM.
Rajul has an MBA with specialization in Operations Management and Information Systems from XLRI Jamshedpur, India. In addition, she has a graduate degree in Electronics & Telecommunication Engineering from SGSITS Indore, India. Rajul holds several industry certifications such as PMP, Medical Affairs Competency Certificate (ACMA), GCP Expert accreditation, Executive Data Science Specialization (Johns Hopkins University), CBAP (Business Analysis) and FAHM (Fellow, Academy of Healthcare Management).
Kristin Ortlieb has over 25 years of experience in the pharmaceutical industry leading medical information contact centers and quality assurance organizations. Innovative and results-driven, Kristin’s passion is designing, implementing, and continually enhancing best-in-class Quality Management Systems for Medical Information and Pharmacovigilance services, which she has done for former employers and in past consulting work.
Across the span of her career, Kristin has held numerous senior leadership roles in Quality Assurance (QA), including Good Manufacturing Practice (GMP) QA and contact center management for companies such as Diligent Health Solutions, Radius Health, and Ashfield Healthcare. Kristin has extensive experience hosting and managing 60+ regulatory audits.
Prior to joining ProPharma, Kristin served as Senior Vice President, Quality & Compliance for Diligent Health Solutions, where she developed and implemented the Quality Management System, with a focus on contact center process improvement and regulatory compliance.
Kristin has a degree in Communications from Penn State University. She is Lean Six Sigma certified.
Carl Barker is Vice President Finance, Europe at ProPharma and has worked in the Pharmaceutical services industry for the past 7 years.
Carl provides the leadership and control of the Finance functions across Europe.
Prior to taking this position Carl was Group Finance Director of Diamond Pharma Services which was acquired by ProPharma in March 2021 a process which he project managed. In this role as Group Finance Director he was responsible for providing financial reporting directly to the board of Directors and Senior Management, identifying and measuring of KPI’s. As part of his role Carl provided leadership to the supporting structures of the business including business administration support, IT infrastructure and processes and outsourced vendor management.
Carl provided the financial control for the group to maintain stability and develop the supporting structure for a growing organization that continued to expand both its physical presence across Europe and staffing numbers.
Prior to joining Diamond Carl held similar positions within the retail sector, with over 17 years industry experience operating within SME’s.
Craig brings a unique blend of Bio/pharma and CRO Talent Acquisition, Executive Search and Agency recruitment experience. With extensive experience in building global talent acquisition infrastructure, optimizing and enhancing operational recruitment and hiring processes, Craig is skilled at creating a cohesive, collaborative and inclusive team environment.
Craig’s 20+ years Life Sciences leadership experience includes leading the Jazz Pharmaceuticals Global TA partner team, the Quintiles (IQVIA) North American Clinical TA team and serving as U.S. Managing Director for Executive Search firm, Sharpstream Life Sciences. Earlier in his career, Craig led Global TA for Art Technology Group (ATG) a 1500 person CRM Software developer and services organization.
Craig received his Bachelor of Arts degree in Journalism, from the State University of New York, at Plattsburgh.
Zosya has over 15 years of diverse marketing experience across Fortune300 companies, CPG industry, fast-moving startups, and in the Life Sciences industry, formerly spear-heading digital capabilities and social media for PRA Health Sciences (Now Icon plc). Zosya has extensive experience building marketing campaigns and digital capabilities from the ground up and laying the foundational practices to launch high-performing, best-in-class teams. Prior roles include Senior Director of Digital Marketing, Global Head of US Social Media, and Director of Marketing across global companies.
Zosya is responsible for ProPharma’s Global Marketing Department and oversees both internal and external communications, strategic marketing, branding and marketing operations for the organization.
Zosya earned her bachelor’s degree from Fordham University in New York City.
News & Insights
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Meet the Expert: Clarence Young
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ProPharma Expands into Central and Eastern Europe Through Acquisition of Clinres Farmacija
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EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
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ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
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Congratulations to our 2015 Colleague Award Winners!
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Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
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News & Insights
December 06, 2023
ProPharma Expands into Central and Eastern Europe Through Acquisition of Clinres Farmacija
RALEIGH, NC, December 6, 2023 – ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and compliance services...
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EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
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ProPharma Launches an Integrated MedTech Organization Providing End-to-End Solutions for Innovators
Raleigh, NC, November 16, 2023: ProPharma Group, the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and quality compliance services for...
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ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook
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April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded "Best Pharmaceutical Regulatory & Compliance...
December 20, 2015
Congratulations to our 2015 Colleague Award Winners!
Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...
Dec 6, 2023 4:06:16 PM
Meet the Expert: Clarence Young
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Nov 27, 2023 7:00:00 AM
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
Nov 20, 2023 7:00:00 AM
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...
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The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
October 4, 2021
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Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...
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October 14, 2021
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November 30, 2021
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EMA Approval Under Exceptional Circumstances
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MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction
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Insider Talks - To Decentralize or Not to Decentralize … That is the Question
Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...
March 21, 2022
Reduced Burden for Oncology Patients With Decentralized Visits
Learn how our team helped implement decentralized visits for an oncology study that reduced patient burden and stress on the sites. Oncology studies often require frequent sample collection visits....
February 4, 2022
AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability
AI can enable MI Contact Centers to transform the customer experience using digital avenues. Join us for our upcoming Insider Talks to find out!
October 14, 2021
Secure Timely Product Launch by Ensuring GDP Compliance Across Europe
Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...
July 26, 2022
Sponsor Successfully Completes Acquisition After Efficient PMA Submission
A major Top 10 Medical Device Sponsor engaged M2, a ProPharma company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how ProPharma...
October 14, 2021
Statistical Analytics with Machine Learning Tool Enablement
Introducing new tools is difficult and comes with a learning curve for even the most experienced, and having clearly defined processes and procedures is critical to your team’s success. If there is...
January 25, 2022
20 Years of Improving Patient Health and Safety
With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.
February 17, 2022
Supporting Decentralized Gene Therapy Visits
Clinical trials often require frequent visits to the investigative site and procedures which can be a turn-off or become the reason many patients cannot commit their time to participate in a study....
December 7, 2021
Cohort Management Process and Planning: Challenges, Risks, and Mitigations
Learn novel and useful drug design methodologies based on ProPharma's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.
November 12, 2021
Expedited Programs Explained: How to Expedite Product Approval in the US and Europe
Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!
October 14, 2021
Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors
Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...
October 15, 2021
What Does it Take to Build a Legacy? (20th Anniversary Video)
October 14, 2021
Understanding Clinical Trial Requirements for Medical Device Label Extensions
After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...
October 14, 2021
Using Science to Achieve EMA Approval for a First-in-Class Indication
See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic. You’re developing a drug, biologic, or medical device product. Your...
October 13, 2021
The True Cost of Non-Compliance
How to avoid getting your first, second, and third warning letter from a federal agency.
October 14, 2021
When a Team Lacks Industry Experience
Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...
October 14, 2021
When a Team Loses Their Leader and Lacks a Plan
Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...
October 4, 2021
ProPharma Overview Video
With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.
June 16, 2023
Evaluate Readiness and Compliance for Supplying Drug Product to EU/UK/EEC
Assessing your progress is of utmost importance when supplying pharmaceutical products to the European Union (EU), United Kingdom (UK), and European Economic Community (EEC), as it ensures compliance...
March 21, 2022
Meeting the FDA's CAPA Expectations
Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...
December 7, 2023
What You Need to Know About Regulatory Programs for Expedited Approval
Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...
February 3, 2022
EU IVDR Progress Self Assessment
The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.
October 14, 2021
EMA Services: Ensure Regulatory Success
Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)
December 7, 2023
Accelerating Your Product Through Drug Development
Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
October 14, 2021
Cell and Gene Therapy Center of Excellence
Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients
October 14, 2021
Data Integrity: The Quality of Your Product Depends on The Quality of Your Data
Regulatory Agencies Expect Controls to Be in Place
October 14, 2021
FDA Consulting: Regulatory Strategy Expertise
Reduce Your Time to Market With an Effective FDA Regulatory Strategy
October 4, 2021
ProPharma Services Overview
Improving Patient Health and Safety. At Every Step.
October 4, 2021
Medical Device Development
Navigate Complex Global Requirements for Medical Device Approval
October 4, 2021
EU Market Access: Accelerate Market Access to Europe with MIA License
Reduce Launch Timeline and Improve Business Efficiency
December 7, 2023
Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)
Save Time and Boost your Bottom Line
October 17, 2021
Outsourcing of Medical Information Content Creation: Experience of 100 Clients
The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...
October 14, 2021
Good Science Presented Well Generates Approval
Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...
October 14, 2021
How to Compile a Science-Backed New Drug Application (NDA) Submission
Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...
October 14, 2021
A Guide for Efficacious Data Integrity During COVID-19
Learn how ProPharma implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains, and...
October 14, 2021
Evolving EMEA MI Service Models
There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...
October 13, 2021
What You Need to Know About GxP Independent Compliance Audits
Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...
October 4, 2021
Outsourcing Medical Information Services: When to Consider a Dedicated Resource
Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...
October 4, 2021
Improving Product Quality During Technical Transfers
Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...
March 31, 2023
6 Key Elements of Successful Drug & Device Development in Europe
Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50...
March 24, 2023
CMC Program Management
Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. An experienced CMC program management consultant developed and facilitated a product...
March 24, 2023
Drug Development Program Management
Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. ProPharma provided an experienced...
March 24, 2023
Medical Affairs
Explore how ProPharma helped a large pharmaceutical company who needed more medical affairs leaders for scientific and project management expertise for their rapidly growing medical affairs...
March 24, 2023
Medical Safety Scientist
This case study outlines the successful collaboration between a pharmaceutical company's medical safety department and an experienced ProPharma safety scientist who was able to handle a spike in...
March 24, 2023
Quality and Analytical Scientist
Learn how ProPharma partnered with a pharmaceutical company who experienced a spike in demand for quality and analytical scientists, necessitating the need for an experienced consultant to take...
March 24, 2023
Regulatory Affairs Project Manager
The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharma’s help. As a result, the client was able...
March 24, 2023
SOPs and Processing Mapping
This case study outlines how a biotech company struggling with compliance and a lack of standard operating procedures (SOPs) turned to ProPharma for help. The consultant recommended a process mapping...
March 29, 2023
Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market
Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...
April 6, 2023
6 Things to Consider When Selecting a Research Platform
Unlocking the Full Potential of Your Life Science Organization: Investing in Digital Initiatives As a leader in the life sciences industry, we know that data is one of the most valuable assets for...
May 3, 2023
Improve Quality & Consistency by Leveraging AI for Trial Master File Classification
Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...
May 16, 2023
Maximizing Patient Outcomes. A Contact Center Needs Assessment.
Unlock the secrets to designing effective patient support programs with our invaluable guide. By embracing a patient-focused approach and utilizing our comprehensive contact center checklist, you can...
May 24, 2023
5 Key Challenges in the Development of Cell & Gene Therapy
Challenges in Cell and Gene Therapy Development Developing and bringing Cell and Gene Therapy (CAGT) products to market comes with significant challenges. This whitepaper focuses on the key obstacles...
June 12, 2023
FSP models for IVD Clinical Trials: Meeting Growing Pipeline Demands
Streamlining Clinical Trial Operations: How the FSP Model Transformed a Mid-Sized Biotech Company's Success. In this case study, we delve into the experience of a mid-sized genetic testing and...
June 21, 2023
Functional Service Provider (FSP) Value Proposition
At ProPharma, we forge strategic partnerships with our clients to collaboratively devise optimal strategies and drive remarkable results and operational excellence. With our cutting-edge FSP...
June 21, 2023
Labeling Development & Intelligence
Our cutting-edge labeling intelligence solution at ProPharma empowers our highly skilled labeling development consultants to offer an unmatched product development strategy and top-tier labeling...
June 27, 2023
Enhancing Site Capacity for Clinical Trials with DCT Nurses
Discover how ProPharma helped a US biotech company focused on rare neurologic conditions overcome challenges in securing qualified resources for their study sites. Our FSP solutions, featuring study...
July 31, 2023
Compliance Auditing: Diving into Common Critical Findings
Compliance Auditing: Diving into Common Critical Findings Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...
October 16, 2023
Biostatistics and Programming - More than Just Clinical Trials
Learn how ProPharma’s Biostatisticians and Programmers enabled a small biotech company to derive more meaningful and actionable insights from their legacy data.
October 19, 2023
Product Quality Complaint Management
Ensuring the safety and health of patients is of utmost significance when it comes to pharmaceuticals, medical devices, and diagnostic programs. This is especially vital in today's intricate and...
November 6, 2023
Tackling Product Quality and Safety Issues through Global Collaboration
See how ProPharma effectively addressed a globally renowned corporation's surge in product quality complaints and financial pressures by establishing a tiered support system, leveraging offshore...
Inspiring the Future of Drug Development
We’ve developed a process that suits today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.