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pharmacovigilance

Industry leading pharmacovigilance solutions from clinical development through post-approval.

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Pharmacovigilance Consultant

Pharmacovigilance Services

How do you choose a Pharmacovigilance (PV) provider? The first step is to focus on the basics of quality, efficiency, and compliance, key factors visible in most every program. The next level involves analyzing how the team responds to your individual needs and ad hoc requests, such as identifying the options available for more unusual projects.

Next, is assessing the culture and "the fit" for this long-term partnership. It’s important to be understood and see eye-to-eye. After all of that, true success in finding the best pharmacovigilance ally requires a higher-level appraisal to see how the PV group functions when you're not even looking.

Are they moving forward without hesitation to be ready for a potential expedited submission? Are efficiency ideas shared proactively with clients? Is there an awareness of upcoming regulatory changes and how they might affect your project?

Ask us the questions. Let ProPharma show you the way we believe every client should be treated — as if their project were our only project.

Pharmacovigilance Solutions

Whether the path ahead includes a first-in-human investigative trial or global product approval, we’re here to help. From clinical development through post-marketing surveillance, your team can rely on our industry-leading PV specialists providing a full suite of services to ensure your PV system fulfills regional and global regulations, and continuously monitors the safety of your products.

ProPharma offers stand-alone contracts utilizing our myriad PV services or integration with global Clinical Research Services, Medical Information, or Regulatory services.

clinical-pharmacovigilance

Clinical Pharmacovigilance

The early stages of a clinical program can be costly, trying to determine the services to trim down and where to really invest. Our solution is a simple yet scalable model starting with the basics: a safety database that can go the distance from clinical studies into post-marketing, a project team that is trained to understand the safety profile of the product and the sponsor’s motivations, and sound regulatory intelligence to navigate the guidances and requirements.

As the global reach and the complexity of the program grows, so too do the possible services, including literature search and review, custom database reports, or signal management. We share your cost concerns and have created options for many of our services from database access to Global Safety Plans—each with different price tags depending on the level of service chosen. You want to choose where to trim down and where to invest, and we want to help.

Post-marketing Pharmacovigilance

Post-marketing pharmacovigilance programs should not be handled applying a one-size-fits-all mentality. Requirements may look very different depending on the country or region in which a marketing authorization is held. The addition of business partners may create the need to write and maintain a safety data exchange agreement or a PV agreement.

Changes to the safety profile of the product may require a more robust signal detection program to be implemented. A health authority may require a post-authorization safety study or a Risk Evaluation and Mitigation Strategy. Whichever way the life- cycle of your product takes you, ProPharma is here to support all of your needs. From our Benefit-Risk team to our QPPV office. Monitoring the safety of our client’s products, it’s what we do every day.

Safety Systems

The Pharmacovigilance System Master File (PSMF) describes the PV system of the Marketing Authorization Holder (MAH) and is a legal requirement for MAHs to maintain and make available to Health Authorities . Prior to inspections, Health Authorities routinely request this document and it can also be requested on an ad hoc basis. Information is included from many stakeholders including Quality Assurance, Regulatory Affairs, and all areas of PV, so keeping the PSMF up-to date is a critical task. Using well-honed processes, standardized templates, and experienced staff, ProPharma can support you with this activity.

The Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategy (REMS) describes the PV system for mitigating risk in a program. These documents identify, characterize, and work to minimize the significant risks of a medicinal product. The overall aim of any risk management program is to ensure that the benefits of the medicinal product exceed the risks by the greatest achievable margin, and here’s where ProPharma can help. Our team of experts can support the preparation and maintenance of your RMP or take over the preparation and maintenance altogether. Our experience extends to the preparation of RMPs for well-established products, generics, innovators, biosimilars, as well as fixed combination products.

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QPPV Office

Appointing an experienced Qualified Person for Pharmacovigilance (QPPV), Local Person for Pharmacovigilance (LPPV), and deputy QPPV/LPPV can require considerable time and resources.

Although the requirements and responsibilities of a QPPV are specified in EU and UK legislation, LPPVs are subject to their own national legislation (e.g., the Graduated Plan Officer "Stufenplanbeauftragter" for Germany), which can also be daunting. As a global pharmacovigilance provider, ProPharma can advise you on the varied requirements for QPPVs and LPPVs to determine the services that will accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location.

Once you’ve identified your requirements, ProPharma can provide appropriately qualified and experienced QPPVs, LPPVs, and deputies globally. We have a world-wide network of QPPVs and LPPVs to serve you with their expertise from Europe to Australia and in more than 50 countries.

Through simple and scalable solutions, we provide tiered options and customized services to fit your needs. Contact us to learn more about our QPPV and LPPV services.

Explore our QPPV Services

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Role of the EU QPPV

Every Marketing Authorization Holder (MAH) in Europe has an obligation to establish a pharmacovigilance (PV) system for the fulfillment of PV tasks for its products. When setting up a PV system in Europe, the MAH must appoint an EU QPPV to establish and maintain the MAH’s PV system. In addition to the establishment and oversight of the PV system, the QPPV also has several legislative responsibilities.

Responsibilities of the EU QPPV include:

  • Establish and maintain the MAH’s PV system
  • Monitor the safety of the MAH’s drug products
  • Coordinate actions to stay compliant with local legislation
  • Serve as the 24/7 point of contact for Competent Authorities
  • Conduct audits and inspections to ensure compliance with EU regulations

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Role of an LPPV

In addition, many European and other countries legally require a Local Person for Pharmacovigilance (LPPV) at a country level who may report to the EU QPPV (e.g., for Germany a Stufenplanbeauftragter is required). Although the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation.

Some QPPVs may have their own network of LPPVs to help fulfill local requirements. As a global pharmacovigilance provider, ProPharma can advise you about the various important requirements for EU QPPVs and LPPVs, to ensure you have the right resources in place to fully comply with the regulations for your PV system in Europe.

Get Expert Guidance Managing Legislation Requirements

ProPharma can support your organization through the provision of appropriately qualified and experienced QPPVs, LPPVs, and deputies.

ProPharma’s experts can advise you about the different roles and responsibilities of the EU QPPVs and LPPVs and offer services that can accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location. We have a team of local persons available to fulfill these positions and strengthen your country PV operations as your company grows. Contact us to learn more about our QPPV and LPPV services.

Explore our LPPV Services

Case Management

At ProPharma, our teams of clinical and post-marketing Pharmacovigilance specialists provide subject matter expertise and comprehensive case processing services that are customized to meet the needs of the client and PV system. We start with the fundamentals of quality, compliance, and efficiency enabling us to build the program you want rooted in the requirements you need.

Case processing at ProPharma includes clinical trial serious adverse events (SAEs), adverse events of special interest (AESI), pregnancies, serious and non-serious spontaneous or solicited cases, legacy cases, literature search cases, and social media cases. The case management process starts with case intake, data entry, MedDRA and WHO Drug coding, followed by narrative writing based on a template approved by the client or sponsor, quality control, medical review, follow up, and reconciliation. Case processing and quality review activities go hand-in-hand, so we pay particular attention to timelines, industry guidelines, and submission requirements for global health authorities.

We offer our clients a fully compliant and validated global safety database as a single repository for the myriad events reported throughout the lifecycle of a product. The Argus platform includes appropriate backup, security measures, business continuity, and disaster recovery procedures and our long history of compliance involves processes and systems which are regularly audited. A global safety database promotes convenience while drafting an Analysis of Similar Events, ease in looking across the multiple datasets involved in aggregate reports and becomes a single source of truth for a product’s safety data.

Speak with our highly skilled data migration team about the options available for combining all of your safety data in one permanent home.

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Global Literature Review

The review of worldwide scientific literature is an essential part of the ongoing safety surveillance of your product, regardless of commercial status. To ensure compliance with regulatory legislation worldwide, it is essential that global and local literature screening is regularly conducted to identify reportable ICSRs and detect potential safety signals.

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Our experienced team at ProPharma can support you or assume full responsibility for these activities to ensure your PV program adheres to the global regulatory requirements. In addition, our services are cost-effective, and we are able to conduct global literature surveillance of the large bibliographical databases including Embase® and Medline®. We have extensive experience in developing robust search strategies for our clients and providing results from these searches according to an agreed upon periodicity. We can perform the review and assessment of identified literature articles, ensure the efficient and auditable documentation of results.

For Marketing Authorization Holders (MAHs) with active substances included in the EMA’s Medical Literature Monitoring (MLM) list, we perform EudraVigilance checks using the ICSR Export module based on the frequency contracted. In addition, we provide local literature searches in relevant local scientific and medical journals in countries where your product is marketed and legally required.

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Signal Management

Signal management is a critical process for the proactive and timely identification of potential new safety risks for medicinal products that requires the utmost expertise. Signal management can be deployed throughout both the clinical development and post-marketing phases of the product lifecycle. Safety issues may affect the benefit-risk balance of the product, requiring updates to product labels and other steps that help protect patients from harm.

ProPharma has deep expertise across all signal management activities, including detection, validation, prioritization, and assessment. We do this using a wide range of sources (e.g., spontaneous cases, safety data from clinical trials, and noninterventional studies and literature reports). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. Using a variety of options, we leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

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Periodic Safety Reports and Risk Management Plans

The Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategy (REMS) describes the PV system for mitigating risk in a program. These documents identify, characterize, and work to minimize the significant risks of a medicinal product. The overall aim of any risk management program is to ensure that the benefits of the medicinal product exceed the risks by the greatest achievable margin, and here’s where ProPharma can help. Our team of experts can support the preparation and maintenance of your RMP or take over the preparation and maintenance altogether. Our experience extends to the preparation of RMPs for well-established products, generics, innovators, biosimilars, as well as fixed combination products.

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The preparation of Periodic Safety Reports is required throughout both the clinical development and post-marketing phases of the product lifecycle. The periodic review of safety data from relevant sources is essential for the ongoing benefit risk evaluation to ensure patients´ safety and well-being.

At ProPharma, our team works diligently to ensure compliance with applicable regulations for aggregate safety reports. We have wide-ranging experience in analyzing and evaluating data and generating required periodic reports such as:

  • Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs),
  • Periodic Adverse Drug Experience Report (PADER),
  • Development Safety Update Reports (DSURs)
  • Country-specific periodic reports

We also can support you in:

  • Responding to Request for Information (RFI) from Regulatory Authorities
  • Preparing the addendum to Clinical Overviews (ACO)
  • Submission of the reports

ProPharma is staffed with highly experienced and qualified staff to ensure a timely development of Periodic Safety Reports and RMPs with high quality.

Global ICSR Submissions

ProPharma recognizes the critical nature of accurate and on-time submissions to health authorities,  Institutional Review Boards (IRBs), and Ethics Committees (ECs). We perform ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) reports for various product types including approved and non-approved drugs, biologics, devices, vaccines, dietary supplements, homeopathic products, and natural health products. ICSRs are exchanged with clients and Sponsors for review and comment before the final submission, if requested. Clients and Sponsors also maintain oversight of case processing and reporting activities ahead of the submission via Case Explorer, a read-only application that allows for real-time database querying and review of database information within individual cases. Clients and sponsors who wish to maintain oversight of case processing within the safety database may also do so via read-only access as part of individual user implementation and security procedures.

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Each month, compliance metrics are generated from the safety database submission reports for all pharmacovigilance and clinical safety programs and shared with all interested clients. ProPharma is proud to post a greater than 99% compliance rate, successfully submitting over 2,000 ICSRs per month to health authorities and business partners on behalf of post-marketing pharmacovigilance clients and clinical safety Sponsors.

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Pharmacovigilance Experts

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Ioana Panturoiu

Managing Consultant
Global Alliance Partners & PV Ops

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Sandy Johnson

Pharmacovigilance Manager

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Angie Robertson

Director
Systems and Analytics

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John Fitzpatrick

Benefit Risk Senior Manager

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Wahabuddin Mohammed

Pharmacovigilance Manager

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Fionnuala Quinn

Senior Client Manager

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Managing Complex Pharmaceutical Projects

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...

Case Study MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction - ProPharma

October 14, 2021

MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction

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...

Case Study Navigating QMS Requirements from a Medical Device Perspective - ProPharma

April 12, 2022

Navigating QMS Requirements from a Medical Device Perspective

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...

Videos Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life - ProPharma

September 28, 2023

Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life

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...

Case Study Overworked Medical Device Teams Missing Deadlines - ProPharma

October 14, 2021

Overworked Medical Device Teams Missing Deadlines

Is your company experiencing rapid growth? Is your team overworked and falling further and further behind? ProPharma Group’s team can help. You may recognize that this is happening but not...

Videos Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective - ProPharma

May 19, 2022

Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective

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...

Case Study Program and Project Management Effectively Deliver a QMS Optimization Program - ProPharma

April 25, 2022

Program and Project Management Effectively Deliver a QMS Optimization Program

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...

Videos Insider Talks - To Decentralize or Not to Decentralize … That is the Question - ProPharma

March 25, 2022

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...

Case Study Reduced Burden for Oncology Patients With Decentralized Visits - ProPharma

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....

Videos AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

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!

Case Study Secure Timely Product Launch by Ensuring GDP Compliance Across Europe - ProPharma

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...

Case Study Sponsor Successfully Completes Acquisition After Efficient PMA Submission - ProPharma

July 26, 2022

Sponsor Successfully Completes Acquisition After Efficient PMA Submission

A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how...

Case Study Statistical Analytics with Machine Learning Tool Enablement - 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...

Videos 20 Years of Improving Patient Health and Safety - ProPharma

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.

Case Study Supporting Decentralized Gene Therapy Visits - ProPharma

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....

Videos Cohort Management Process and Planning: Challenges, Risks, and Mitigations - ProPharma

December 7, 2021

Cohort Management Process and Planning: Challenges, Risks, and Mitigations

Learn novel and useful drug design methodologies based on ProPharma Group's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.

Videos Expedited Programs Explained: How to Expedite Product Approval in the US and Europe - ProPharma

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!

Case Study Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors - ProPharma

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...

Videos What Does it Take to Build a Legacy? (20th Anniversary Video) - ProPharma

October 15, 2021

What Does it Take to Build a Legacy? (20th Anniversary Video)

Case Study Understanding Clinical Trial Requirements for Medical Device Label Extensions - ProPharma

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...

Case Study Using Science to Achieve EMA Approval for a First-in-Class Indication - ProPharma

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...

Videos The True Cost of Non-Compliance - ProPharma

October 13, 2021

The True Cost of Non-Compliance

How to avoid getting your first, second, and third warning letter from a federal agency.

Case Study When a Team Lacks Industry Experience - ProPharma

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...

Case Study When a Team Loses Their Leader and Lacks a Plan - ProPharma

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...

Videos ProPharma Group Overview Video  - ProPharma

October 4, 2021

ProPharma Group 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.

Guide Assess Your Readiness for Supplying Drug Product to Europe and UK

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...

Whitepapers Meeting the FDA's CAPA Expectations - ProPharma

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...

Whitepapers What You Need to Know About Regulatory Programs for Expedited Approval - ProPharma

September 28, 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...

Flyers EU IVDR Progress Self Assessment - ProPharma

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.

Flyers EMA Services: Ensure Regulatory Success - ProPharma

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers Accelerating Your Product Through Drug Development - ProPharma

September 28, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers Cell and Gene Therapy Center of Excellence - ProPharma

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers Data Integrity: The Quality of Your Product Depends on The Quality of Your Data - ProPharma

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

Flyers FDA Consulting: Regulatory Strategy Expertise - ProPharma

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers ProPharma Group Services Overview - ProPharma

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers EU Market Access: Accelerate Market Access to Europe with MIA License

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

September 28, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook Outsourcing of Medical Information Content Creation: Experience of 100 Clients

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...

Whitepapers Good Science Presented Well Generates Approval

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...

Whitepapers How to Compile a Science-Backed New Drug Application (NDA) Submission

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...

Whitepapers A Guide for Efficacious Data Integrity During COVID-19

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...

eBook Evolving EMEA MI Service Models

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...

Whitepapers What You Need to Know About GxP Independent Compliance Audits

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...

eBook Outsourcing Medical Information Services: When to Consider a Dedicated Resource

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...

eBook Improving Product Quality During Technical Transfers

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...

Guide 6 Key Elements of Successful Drug & Device Development in Europe

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...

Case Study CMC Program Management Case Study

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...

Case Study Drug Development Program Management Case Study

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...

Case Study Medical Affairs Case Study

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...

Case Study Medical Safety Scientist Case Study

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...

Case Study Quality and Analytical Scientist Case Study

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...

Case Study Regulatory Affairs Project Manager Case Study

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...

Case Study SOPs and Processing Mapping Case Study

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...

Case Study Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

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...

Guide 6 Things to Consider When Selecting a Research Platform

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...

Whitepapers Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

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...

Guide Maximizing Patient Outcomes. A Contact Center Needs Assessment.

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...

Whitepapers 5 Key Challenges in the Development of Cell & Gene Therapy

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...

Case Study FSP models for IVD Clinical Trials:  Meeting Growing Pipeline Demands

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...

Flyers Functional Service Provider (FSP) Value Proposition

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...

Flyers Labeling Development & Intelligence

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...

Case Study Enhancing Site Capacity for Clinical Trials with DCT Nurses

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...

Whitepapers Compliance Auditing: Diving into Common Critical Findings

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...

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