As an industry leader, ProPharma is committed to delivering insightful research and perspectives developed by top subject matter experts. ProPharma provides valuable insights to its clients to enable thoughtful decision making, as well as informed resource & investment allocation.
Unlock the Full Potential of the Orphan Drug Act A Comprehensive Guide to FDA's Orphan Drug Designation The Orphan Drug Act (ODA) has transformed rare disease drug development by incentivizing pharmaceutical companies to create life-saving treatments. However, successfully...
Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...
Discover how ProPharma enabled a leading global biopharma to overcome fragmented clinical sample management and outdated manual processes. Faced with disparate systems, off-site inventories, and...
Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...
Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...
Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...
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Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...
Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...
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A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic...
For Medical Information (MI) teams navigating today’s evolving regulatory landscape, compliance isn’t just a requirement — it’s a strategic imperative. From managing off-label inquiries to...
Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...
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A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...
Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch...
A U.S. pharmaceutical firm needed a global safety database live in four weeks, handling 4,000 legacy cases and active trials. ProPharma delivered a fully configured solution using tailored data...
Discover how ProPharma managed over 40 complex tech transfer projects involving API, bulk, and packaging site changes under tight timelines. By establishing a clear project management structure,...
ProPharma rapidly deployed a skilled team to support over 8,000 global Medical Device Reports under tight deadlines and complex regulatory requirements. By establishing a strong project management...
Discover how a U.S. radiopharmaceutical start-up partnered with ProPharma to meet EU GMP requirements for a late-stage clinical trial targeting GEP-NETs. Facing challenges with the Qualified Person...
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Is your site inspection-ready—every day, at any time? With regulatory authorities increasing unannounced inspections and enforcement actions, the need for all-time readiness has never been more...
Discover the critical role of Safety Services in clinical trials and how to select the right pharmacovigilance (PV) vendor. It highlights the key evaluation criteria—such as experience, regulatory...
Learn how ProPharma transformed quality data analysis for a global medical information service by implementing an interactive data tool. This innovative solution streamlined trend detection, reduced...
Discover how ProPharma helped a pharmaceutical sponsor overcome critical site support and staffing challenges with a comprehensive support strategy encompassing both Functional Service Provider (FSP)...
Unlock the Full Potential of the Orphan Drug Act A Comprehensive Guide to FDA's Orphan Drug Designation The Orphan Drug Act (ODA) has transformed rare disease drug development by incentivizing...
Mastering the New European Health Technology Assessment Regulation (HTAR) Your Essential Guide to Successful Market Access in the EU Are you ready for the 2025 EU HTA changes? The European Health...
We believe an organization should successfully realize its early/ late-stage development goals through an effective project management ability. ProPharma's Drug Development Project Management...
ProPharma's General Project Management Capability Self-Assessment is designed to help organizations measure their alignment with strategic goals and their efficiency in managing projects. It...
Discover how ProPharma supported a mid-sized European pharmaceutical company in achieving full reimbursement for their products across the Nordic markets of Denmark, Finland, and Sweden. This case...
Learn how ProPharma helped SMi Systems establish a robust Quality Management System (QMS) while building their company from the ground up. This case study details their journey to ISO 13485:2016...
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...
A ProPharma Medical Information (MI) Lead working alongside a pharmaceutical company successfully streamlined the adverse event (AE) reporting process in the JAPAC region, particularly addressing...
ProPharma partnered with Apexon to dive into the world of complex therapies. This eBook explores the challenges patients face while undergoing treatment for complex, rare, and oncological conditions....
A medical device start-up aimed to bring their innovative device to the global market, focusing on the United States and European Union. The client faced the challenge of navigating complex...
ProPharma was referred to engage with with a small contract manufacturer who received a Form 483 Observation heading into a holiday weekend. The Quality & Compliance team was able to mobile quickly...
ProPharma comprehensive Digital Blueprint service is aimed at guiding organizations through their digital transformation journeys. After a thorough assessment of the current state, we identifying key...
Discover how ProPharma facilitated a digital transformation at Quell Therapeutics, a UK-based cell therapy company. Through the Digital Blueprint assessment and stakeholder interviews, ProPharma...
ProPharma enhanced data governance for a global biopharma company, streamlining R&D data standards and integrating software systems. This initiative transformed R&D data into a strategic asset,...
We assisted a Munich-based biotech specializing in monoclonal antibody-based therapeutics in transitioning from paper-based processes to an advanced R&D data management platform. Through our Digital...
This case study details the challenges faced by a UK-based pharmaceutical company with over 300 employees across multiple European locations, which had expanded through mergers and acquisitions. The...
This ProPharma case study outlines our work with a rapidly expanding UK-based Gene Therapy Biotech company, addressing challenges like unstructured data silos, inconsistent data capture, and...
In the rapidly evolving healthcare landscape, the need for a cohesive and responsive medical information system is crucial. ProPharma addressed challenges faced by a healthcare client, including...
This whitepaper from ProPharma discusses how leaders in the pharmaceutical and medical device industries can use Agile development methods on their non-software related projects. Learn more about...
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...
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...
Learn how ProPharma’s Biostatisticians and Programmers enabled a small biotech company to derive more meaningful and actionable insights from their legacy data.
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...
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...
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...
Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK Markets? You are in the process of obtaining an MA or CTA to bring your product to EEA/UK markets, which can be a complex...
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...
A global medical device company asked ProPharma to assess the set-up of the entire supply chain of a drug product. We did so by reviewing the Global Quality Management System and we determined how it...
As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...
Given the challenging scheudules and competing priorities, companies have minimal time to proactively address optimization of their QMS. There's very little time for addressing prioritized...
Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...
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...
Learn how ProPharma helped implement and execute decentralized visits for a pediatric rare disease study. The COVID-19 pandemic caused major disruption to many clinical trials and the participants...
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...
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....
There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...
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....
AI can enable MI Contact Centers to transform the customer experience using digital avenues. Join us for our upcoming Insider Talks to find out!
Accessing new market is in the European Union can be a challenge especially when having to navigate both specific country and general European regulation. Read how ProPharma used their deep...
The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.
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.
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.
Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team. ProPharma’s team of Regulatory Sciences experts...
How we worked with an approved BLA to fit EU requirements for an MAA submission, resulting in EMA approval. You’ve developed a novel drug and obtained FDA approval. Your work is done, right? Not if...
Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!
One of the main challenges in adopting a global enterprise quality management system is the complex nature of separate existing tools, applications, and spreadsheets that companies often acquire or...
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...
Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...
Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...
Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...
Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...
Launching a large, enterprise technology solution with a global team is a big undertaking for even the most experienced teams and largest companies. Implementing a technology solution of this...
Reaching patients in the EU with needed medicinal products is a complex undertaking that not only requires knowledge of varied regulatory landscapes, companies must also man, the services of a...
In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...
When performing initial qualification audits, it’s important to evaluate all critical systems evenly to ensure compliance. Lack of evaluation of all critical systems can leave Sponsors and their...
A routine safety letter to healthcare professionals (HCPs) was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety...
Regardless of your internal resources, it could be extremely taxing and unrealistic to expect your team to accomplish both their normal daily activities as well as the work necessary to ensure...
Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...
Is your company experiencing rapid growth? Is your team overworked and falling further and further behind? ProPharma’s team can help. You may recognize that this is happening but not necessarily know...
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...
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...
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...
Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)
Reduce Your Time to Market With an Effective FDA Regulatory Strategy
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...
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...
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...
Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients
Regulatory Agencies Expect Controls to Be in Place
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...
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...
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...
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...
How to avoid getting your first, second, and third warning letter from a federal agency.
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...
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...
Translating regulatory guidance into success for your organization is difficult when there is not a consistent industry standard. Coupled with new processes and procedures within a company that has a...
Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...
Workflows between Electronic Lab Notebooks (ELNs), Laboratory Information Management Systems (LIMS), Scientific Data Management Systems (SDMS), instruments, and robotics are immensely complex and...
A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...
There are many obstacles your team may face during product development. One of the hurdles includes project management struggles associated with having too many decision makers. Although it is one...
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.
Improving Patient Health and Safety. At Every Step.
Navigate Complex Global Requirements for Medical Device Approval
Reduce Launch Timeline and Improve Business Efficiency
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...
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...
Medical devices are regulated by the Center for Devices and Radiological Health (CDRH) at the FDA. Which approval pathway is appropriate for your product? You have developed a medical device and are...
See how we helped an emerging Biotech Sponsor achieve an enrollment rate and average time to FPI that is well above industry benchmarks. An emerging Biotech Sponsor needed management and full-service...
Ensuring accurate and honest data collection is essential for maintaining the integrity of research. Even though the right mindset is the start of data integrity compliance, that alone is not enough...
Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...
Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
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...
In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...
Save Time and Boost your Bottom Line
September 18, 2025
Learn how to select the right CMO partner for your company's needs with ProPharma's CMO Compass tool. Avoid delays and regulatory issues by following a systematic selection process.
September 17, 2025
Key takeaways from FDA’s latest enforcement letters which mark a major shift in advertising oversight and highlight new compliance risks for Sponsors.
September 10, 2025
FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.
July 8, 2025
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
