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post-market monitoring

Highly qualified experts & technology to ensure continued commercial safety and access.

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Although pre-clinical trials provide important information regarding safety and effectiveness, it is possible that new safety concerns will emerge. As a result, health authorities continue to monitor performance after approval. ProPharma’s expertise spans across the following Post-Market competencies:

  • Market Development and Commercial Readiness
  • Patient Reported Safety & Outcomes
  • Real World Evidence
  • Labeling & Promotional Review
  • Risk Management Plans

 

 

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Post-Market Monitoring

Real world and observational studies to support long term drug evaluation and integrated marketed product maintenance activities for continued commercial differentiation, safety, and access.

Patient Reported Safety and Outcomes

Adverse Event (AE) Intake and Follow-up Services

Our skilled staff follows established processes and guidelines to obtain timely, accurate, and comprehensive adverse event information. All AE data is thoroughly documented in either our fully validated database or your MI database, and AE case records are sent to the designated pharmacovigilance (PV) department within one business day. Our experienced MI team is also fully equipped to execute outbound follow-up communication, to collect additional data that was not available at initial intake and lessen the burden on your pharmacovigilance department. For a seamless experience, ProPharma offers comprehensive AE processing and reporting through our dedicated pharmacovigilance team to supplement or fully outsource your existing PV function.

 

 

Adverse Intake and Followup

 

Product Complaint Intake and Follow-up Services

As your trusted MI partner, our highly trained staff follow established processes and guidelines for handling PQC events, to meet both regulatory reporting requirements as well as your company’s own internal quality and manufacturing standards. Our experts can conduct case follow-ups and/or provide full case processing on your company’s behalf. We are dedicated to supporting your customers and patients, beyond just satisfying regulations.

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Real World Evidence

ProPharma's team of experts support Real World Evidence (RWE) research efforts so that clients can make faster decisions and have better insight into their products and meet key stakeholder needs.

Our team takes a customized approach to RWE that assesses each client's specific needs and develops strategic solutions that support their asset leading up to commercial launch and beyond.

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RWE services include:

  • Non-Interventional Studies
    • Registries (product, indication)
    • Database driven (EMR, etc.)
  • Systematic and targeted literature reviews
    • Data Dissemination/Publications
  • Synthesis and Modeling
    • Economic Modeling
    • Dossier and Submission Support

Labelling & Promotional Review

Compelling, Compliant Information to Successfully Promote Your Product

Any activity undertaken, organized, or sponsored by a company that is intended to promote the prescription, recommendation, supply, administration, or consumption of a pharmaceutical, biotechnology, or medical device product may be considered promotional material. Such marketing collateral can be available through various methods of communication, including ads and brochures, mailings, websites, congress materials, and presentations from spokespersons or medical representatives. This content must follow strict European Union (EU) and national guidelines relating to the promotion of medicines, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) code of practice.

During every step of the product lifecycle, your product’s messaging to healthcare professionals and patients must always be clear, compelling, and fully compliant. Whether you’re developing print materials, websites, digital sales aids, or patient support materials, ProPharma has the knowledge and experience to help ensure all of your marketing materials are balanced and aligned with all regulatory and ethical codes.

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Fair Balance, Compliance, and Business Objectives

Promotional material has two equally important objectives:

(1) it must achieve business goals, and (2) it must comply with regulatory constraints. Any promotional material must always accurately present both risks and benefits, and all claims need to be truthful, substantiated, and non-misleading.
At ProPharma, our experts can ensure that you adhere to applicable laws, regulations, and industry standards while maintaining the highest ethical standards for reporting of your sales, marketing, and promotional material in the EU/European Economic Area (EEA). We can help with all aspects of creating and publishing promotional material, including:

  • Regulatory review of promotional and non-promotional materials and activities in accordance with the respective ethical codes in the local country
  • Creation and update of Abbreviated Product Information (API) texts
  • Support in setting up a routine for local review of promotional materials in the local country
  • Advice on general questions regarding the local ethical codes

Medical & Regulatory Advertising Promotional Review

ProPharma provides medical and regulatory review services with our experienced staff that are overseen and mentored by leaders who have sat in your chair:

 

  • Service provider in over 100 companies of all shapes and sizes
  • Experience in pharmaceutical, biotechnology, medical device (Class I, II, III), nutritional supplements, animal health and cosmetic products
  • Collaborative professionals who launch new products (pre-approval, launch and post-approval brand support), maintain growth and legacy products
    • Promotional Materials - HCP, Consumer and Managed Care
    • Press/Public Affairs Materials and Activities
    • Medical Affairs/R&D Materials

Regulatory Review

Experienced and collaborative regulatory professionals.
  • OPDP or APLB product advisory comment submissions –authoring, editing, and preparation
  • Successful interactions with OPDP
  • Guide teams through FDA regulations, guidance documents and enforcement communications
  • Deep understanding of trial design and outcomes

Medical Review

Cost-effective resources to manage day-to-day review responsibilities, without sacrificing scientific accuracy or integrity.

  • Promotional and Medical Review Committee participation
  • Medical accuracy and evidentiary standard review (substantial evidence, competent and reliable/FTC)
  • Broad therapeutic experience

Labeling Development  

The ProPharma team includes experienced staff to help companies develop HCP and consumer labeling for prescription drugs and biologics.  

ProPharma provides strategic support to your team. Our experienced staff can manage the entire product labeling process, including development of:

  • Company Core Data Sheets (CCDS)
  • U.S. package inserts
  • Medication guides
  • E.U. Summary of Product Characteristics (SPC)
  • Patient Information Leaflets (PIL)

Develop labeling content, manage and support complex labeling and regulatory situations, manage health authority communications, and assist in the design of your company’s labeling policy and process - that's what we do at ProPharma.

Talk with an Expert

Labeling

Compliance Program Development & Monitoring

ProPharma helps companies develop and maintain effective compliance programs. Monitoring and Auditing Support. The compliance monitoring program at ProPharma includes:

  • Field monitoring:  ride-alongs, speaker programs and other events
  • Monitoring of data analytics from sales representatives, HCP interactions, and email Strategic monitoring plans such as quick start guides and plans for protocol development

Compliance Program Development

ProPharma helps small companies develop ethics and compliance programs using the Office of the Inspector General’s seven elements of an effective compliance program as a starting point and then develop programs to meet state and federal compliance requirements to avoid unwanted scrutiny, enforcement, and fines. To make that happen, we implement our proprietary four-step process:

  • Perform program assessment
  • Identify and document inherent compliance risks
  • Compliance program development 
  • Compliance monitoring and support

Talk with an Expert

Regulatory Operations

ProPharma helps companies implement the correct solutions of processes, standards, systems, templates, and best practices for effective Regulatory Operations. With the right Regulatory Operations group, you can achieve high quality document management, data management, and regulatory agency submissions.

ProPharma provides strategic support to your team.  Our experienced staff can assist with:

  • Process Optimization
  • System Implementations
  • Document Management
  • Submission Management
  • Publishing
  • Archiving
  • RIM
  • Submission Managers
  • Publishers
  • Fully Outsourced Regulatory Operations

Marketing Operations

Promotional Material Review Process & Marketing Materials Management 

  • Commercial Operations Infrastructure Build & Support (Policy, Process, and Procedure Development)
  • Promotional Material "Medical, Legal, Regulatory (MLR)" Review Process Management
  • Technical System Implementation (Veeva/PromoMats)
  • Marketing Materials Execution Project Management (Print & Digital Production and Distribution)
  • HCP & Patient Speaker Bureau and Speaker Program Operations Management
  • Medical Conventions, Exhibits, Meetings & Events Management
  • Vendor/External Partner Procurement & Management
Talk with an Expert

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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 Overview Video  - ProPharma

October 4, 2021

ProPharma Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

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

December 1, 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

December 1, 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 Services Overview - ProPharma

October 4, 2021

ProPharma Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development from ProPharma

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 - Flyer

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) - Flyer

December 1, 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 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 Good Science Presented Well Generates Approval - A ProPharma Whitepaper

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 Whitepaer

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 Whitepaper

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

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

eBook Evolving EMEA MI Service Models 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 Whitepaper: 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 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 Improving Product Quality During Technical Transfers 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...

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 Case Study

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 Guide to 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 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 Case Study

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 Flyer

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 Case Study

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 Whitepaper

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...

Case Study Biostatistics and Programming - More than Just Clinical Trials - A ProPharma Case Study

October 16, 2023

Biostatistics and Programming - More than Just Clinical Trials

Learn how ProPharma’s Biostatisticians and Programmers enabled a small biotech company to derive more meaningful and actionable insights from their legacy data.

Flyers Product Quality Complaint Management - ProPharma

October 19, 2023

Product Quality Complaint Management

Ensuring the safety and health of patients is of utmost significance when it comes to pharmaceuticals, medical devices, and diagnostic programs. This is especially vital in today's intricate and...

Case Study Case Study: Product Quality and Safety Issues with Global Collaboration

November 6, 2023

Tackling Product Quality and Safety Issues through Global Collaboration

See how ProPharma effectively addressed a globally renowned corporation's surge in product quality complaints and financial pressures by establishing a tiered support system, leveraging offshore...

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