pharmacovigilance

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

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Pharmacovigilance Consulting Services

ProPharma's team of highly qualified pharmacovigilance experts, combined with integrated technology, ensures your product meets the highest levels of compliance with both regional and global pharmacovigilance regulations. We are well equipped to expand as your business grows, guiding you through every step of the pharmacovigilance process and pivoting to meet your developing needs. ProPharma’s team of experts is prepared to handle large case volumes at a global scale, supporting clients throughout the complete product lifecycle. Our pharmacovigilance services are available on a standalone basis or can be integrated with global Medical Information and Regulatory Sciences.

All Pharmacovigilance Solutions

ProPharma’s pharmacovigilance consulting services ensure safety and consistency through your product’s entire lifecycle.

 

Pharmacovigilance

ProPharma’s team of highly qualified pharmacovigilance (PV) experts, combined with integrated technology, ensures that your product meets the highest levels of compliance with both regional and global PV regulations. Your team can rely on our industry-leading PV specialists who provide a full suite of pharmacovigilance services that ensure safety and consistency, from clinical development through post-approval.

As your business grows, we are well-equipped to guide you through every step of the PV process and pivot to meet your developing needs. Our pharmacovigilance consulting services team is prepared to handle large case volumes and operates globally, supporting clients throughout the complete product lifecycle. Our PV services are available on a standalone basis or can be integrated with global Medical Information and Regulatory services.


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clinical-pharmacovigilance

Clinical Pharmacovigilance

We employ a robust professional staff of healthcare providers that work across a broad range of therapeutic areas when it comes to clinical pharmacovigilance. Our PV experts ensure safety and consistency throughout your clinical trials. Our global team helps develop and deploy your drug safety programs through the entire lifecycle of your product. This starts with defining the roles and communication with safety management plans (SMPs) and verifying the effectiveness of clinical trials through clinical pharmacovigilance auditing services.

Postmarketing Pharmacovigilance

Once your medical product is in use, our postmarketing PV and drug surveillance help monitor concerns around potential new safety risks and comply with global regulatory requirements. We are proud to be an industry leader in providing global, comprehensive drug safety services to supplement or fully outsource your existing PV function.

A Global Team of Trusted PV and Drug Experts

Our pharmacovigilance consulting team consists of experienced healthcare professionals such as PharmDs, Nurses, and Medical Doctors and works as your collaborative partner, in support of our mission to improve patient health and safety.

Whether you need standalone PV services or integrated global pharmacovigilance, medical information, and regulatory services, ProPharma can support your specific needs.

  • QPPV and LPPV Services - Our fully qualified PV specialists utilize their wide-ranging experience in pharmaceuticals, regulatory, and academia to provide comprehensive QPPV and LPPV services.
  • Single-Source Provider - 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.
  • 24/7/365 Multilingual Services - Our “follow the sun” capabilities and native-speaking specialists in more than 30 languages allow our team to support clients anywhere in the world

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Safety Systems

Safety Management Plan (SMP) Development

The Safety Management Plan (SMP) is one of the most important documents because it regulates all safety communication between the Sponsor and the Contract Research Organization (CRO). The SMP details the roles, responsibilities, processes, and timelines for all safety activities. It ensures a systematic approach to safety monitoring and promotes early issue detection to help mitigate any safety risks in clinical trial subjects and patients.

At ProPharma, we partner with you to create an SMP that includes a Development Risk Management Plan, Safety Monitoring Plan, and other postmarketing safety documents. We collaborate with your team to minimize compliance gaps and to create efficient safety data management.

Our experts follow the latest industry trends requiring a more proactive approach to pre- and post-clinical safety surveillance activities to ensure patient safety throughout the drug development lifecycle.

Clinical Pharmacovigilance (PV) Auditing Services

Pharmacovigilance (PV) Audits are designed to verify the appropriateness and effectiveness of the implementation and operation of a PV system, including its quality system.

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Our PV audits cover the whole PV system (case intake, adverse events processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing, signal and risk management, clinical safety, etc.). Our pharmacovigilance auditing services review compliance applicable to FDA and EMA regulations, guidelines, and standards; third-party agreements; specifications; protocols and policies; standard operating procedures; and work instructions.

We are the preferred PV audit service provider for many large and small pharmaceutical companies where our team performs over 100 (remote and on-site) audits on behalf of our clients each year. We have served and maintained long-term relationships with more than 400 clients across the United States, Canada, Japan, and Europe.

Data Safety Monitoring Board

Data Safety Monitoring Board (DSMB) services provide you with improved workflows, compliance, and communication to ensure the safety and integrity of your clinical study data.

Our team of consultants provides the option of safety data review (i.e., individual case safety reports and/or aggregate summaries of data) by a physician with experience in pharmacovigilance. The review and consultation include an assessment of the data and its significance to the conduct of the study. Our team then provides a recommendation for any actions to be taken, including reporting of aggregate data to the FDA as an IND Safety Report, requesting review by the DSMB, and/or changes to the Investigator’s Brochure, Informed Consent Form, or study protocol.

ProPharma’s DSMB, medical monitoring, and physician teams support a wide variety of therapeutic areas and will meet your requirements and keep your study moving forward by providing any or all of the following services:

  • DSMB program support
  • Blinded and unblinded DSMB meeting support
  • Eligibility requirements review for inclusion/exclusion criteria issues
  • Protocol review for exemptions and deviations
  • Medical crisis impact review involving a study patient
  • Biostatistician review
  • Laboratory findings review
  • Reporting a serious adverse event (SAE)
  • Causality assessment discussions
  • Clinical Trial Emergency Unblinding Services

Medical Monitoring Services

Safety and compliance are essential for clinical trials, which require the oversight of an experienced medical monitoring team. At ProPharma, our team can evaluate your medical monitoring system to ensure there are no pharmacovigilance medical monitoring bandwidth issues, and partner with you to ensure you have the right resources to keep your clinical trials on schedule.

ProPharma’s medical monitoring consultants help you meet requirements to maintain quality and compliance throughout your clinical trials. Our medical monitors have vast knowledge in a wide variety of therapeutic areas and partner with you to address all your needs, including:

  • Inclusion/exclusion criteria issues
  • Protocol exemptions and deviations
  • Medical crisis monitoring for cases involving a study patient
  • Medication issues
  • Laboratory findings
  • SAE reporting
  • Causality assessment discussions

Our medical monitoring consultants will work with you to ensure safety and compliance throughout your clinical trials, from pre-trial planning through end-of-trial review.

Contact us to learn more about our medical monitoring services and how we can provide expert guidance for your upcoming clinical trials.

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QPPV Office

Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV) services from ProPharma ensure your pharmacovigilance (PV) system meets European Regulatory Requirements. Through simple and scalable solutions, we provide tiered options and customized services to fit your needs.

The QPPV and LPPV roles are critical for ensuring compliance with EU regulatory requirements and the safety of products marketed in the EU. Appointing the right EU QPPV can require considerable time and resources, which is why some organizations are outsourcing this role to experienced third parties. Learn about the importance of a QPPV and LPPV along with information on our services to help with your pharmacovigilance operations.

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.

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Case Management

At ProPharma our Clinical Pharmacovigilance (PV) Individual Case Safety Reports (ICSR) Specialists provide project management, subject matter expertise, and case processing services that are customized to meet clients’ needs.

Our internal healthcare professionals (nurses and PharmDs) complete all case processing and quality review activities with particular attention to timelines and submission requirements for global regulatory authorities. As a provider of both clinical and postmarketing PV services, we provide one global safety database and ensure a smooth transition from clinical to postmarketing safety services.

Individual Case Safety Reports (ICSR) Processing and Submission

Clinical Pharmacovigilance Expertise and Resources

The capture and analysis of safety data is critical in clinical trial management as trials must thoroughly demonstrate safety and efficacy. At ProPharma, our Clinical Pharmacovigilance (PV) Individual Case Safety Reports (ICSR) Specialists provide project management, subject matter expertise, and case processing services that are customized to meet clients’ needs.

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Our internal healthcare professionals (nurses and PharmDs) complete all case processing and quality review activities with particular attention to timelines and submission requirements for global regulatory authorities. As a provider of both clinical and postmarketing PV services, we provide one global safety database and ensure a smooth transition from clinical to postmarketing safety services.

Reduce Time and Expense with Our High-Quality Processing

Our extensive experience in providing clinical pharmacovigilance services specializing in ICSR processing and analyzing safety data includes case intake, data entry, coding, medical review, follow up, quality control, and reconciliation.

We support clients by providing ICSR processing in a fully compliant and validated safety database. Our system is secure and has appropriate backup, business continuity, and disaster recovery procedures in place. Our processes and systems are regularly audited and have a long history of compliance. In addition, we have knowledge and experience with all major safety databases.

We also have specialized submissions teams who are qualified for electronic submissions to regulatory authorities and reporting to investigators, Institutional Review Boards (IRBs), and Ethics Committees (ECs).

Aggregate Safety Report Generation and Reporting

High-Quality Postmarketing Report Writing

Within aggregate safety reports, safety data from relevant sources are periodically reviewed and assessed for patients’ safety and well-being.

At ProPharma, our team works diligently to ensure compliance with applicable regulations for aggregate safety reports. We have extensive knowledge in pharmacovigilance and aggregate safety report writing, and practical experience from the pharmaceutical industry, regulatory authorities, and academic settings.

Aggregate Safety Report Services and Expertise

Our full Aggregate Safety Report services include planning, time management, data requests, writing, quality control, strategic advice, communication, and evaluation. We have wide-ranging experience in analyzing and evaluating data and generating required periodic reports such as the Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).


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Global Literature Review

Single source of truth for regulatory intelligence.

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Partnering with You to Ensure Compliance

To ensure compliance with regulatory legislation worldwide it is essential that global and local literature screening identify reportable ICSRs and detect new safety signals for emerging safety issues.

Our experienced team at ProPharma can support you with these activities to ensure your pharmacovigilance (PV) program adheres to the global regulatory requirements.

Wide Range of Postmarketing Services

ProPharma’s comprehensive suite of services ensure you meet all PV obligations.

Our services are cost-effective, and we are able to conduct global literature surveillance of the large bibliographical databases of Embase® and Medline®.

We have extensive experience in developing robust search strategies for our clients and provide results from these searches according to an agreed periodicity.

We help with the review and assessment of identified literature articles, ensure the efficient and auditable documentation of results, and write company comments for articles relevant for PSURs, PBRERs, and ICSRs.

For Marketing Authorization Holders (MAHs) with active substances included in the EMA’s Medical Literature Monitoring (MLM) list, we perform weekly EudraVigilance checks using the ICSR Export module.

In addition, we provide local literature searches in relevant local journals of every EU country where your product is marketed.

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Signal Management

Signal management is a complex pharmacovigilance topic that requires the utmost expertise. ProPharma offers signal detection, triage, and evaluation of potential health risks of adverse reactions indicated in ICSRs to comply with legal and regulatory expectations. 

Postmarketing Methodologies that Improve Patient Safety

Signal management is a critical process for the proactive and timely identification of potential new safety risks for medicinal products. 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.

At ProPharma, we have industry and regulatory experience with various signal management methodologies. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

Wide-Ranging Signal Management Services

Signal management can be deployed throughout both the clinical development and postmarketing phases of the product lifecycle.

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 ensure that MAHs comply with their obligations for signal detection and management.

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Global Submissions

The PV Systems and Submissions Team includes several dedicated Submission Specialists who work in coordination with Client Services and the Case Processing Team to implement reporting requirements into the safety database and submit ICSRs on behalf of postmarketing pharmacovigilance clients and clinical safety Sponsors.

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Reports

ICSR submissions include 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. 

Compliance

ProPharma has a greater than 99% compliance rate, successfully submitting over 2,000 ICSRs per month to health authorities (FDA, EMA, Health Canada) and safety partners. Compliance metrics are generated via safety database submission reports for all pharmacovigilance and clinical safety clients.

Client Oversight and Collaboration

Reports are exchanged with clients and Sponsors for review and commenting before the final submission. 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 population 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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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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January 26, 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

October 15, 2021

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

Case Study

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

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

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

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

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

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.  

Flyers

August 8, 2022

QP MIA Survey - Progress Self-Assessment

Use this readiness questionnaire to assess the current state of your progress.

Whitepapers

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

January 26, 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

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

October 14, 2021

EMA Services: Ensure Regulatory Success

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

Flyers

January 26, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers

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

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

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers

October 4, 2021

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

Reduce Launch Timeline and Improve Business Efficiency

Flyers

January 26, 2023

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

Save Time and Boost your Bottom Line

eBook

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

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

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

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

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

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

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

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...

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Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.