medical writing services

An industry leader in providing global, strategic, responsive, and flexible medical writing project support.

Woman writing in notebook

Whether you need project-based support for individual medical writing deliverables or to outsource all medical writing across an entire clinical trial or a complete portfolio of products, our expertise and experience can be leveraged to ensure all your project goals are achieved.

Medical Writing Services

 

ProPharma provides comprehensive medical writing and document management services for all clinical and safety documentation required throughout the drug development lifecycle as well as other scientific communications.

Core strengths include the experience of our team and the ability of our talented medical writers to distill and assimilate scientific data to produce clear, concise, credible, and complete deliverables.

Hands typing on keyboard

ProPharma medical writers:

  • Autonomously drive the document development process
  • Make early contact with the team, identify key stakeholders, and establish clear expectations
  • Work with the team to develop timelines, determine project drivers, and assess all potential risks early in the process
  • Lead document development, develop and refine key messages, and coordinate and manage input from cross-functional stakeholders
  • Manage client review cycles, comment adjudication, and quality review
  • Facilitate signoff, publishing, and distribution of final, approved documents

Benefits of Working with Our Medical Writing & Editing Team

Around the world icon

GLOBAL AND EXPERIENCED

Our medical writers are located across North America, UK, EU, Australia, China, Japan, and India. Our writers have an average of 8 years of writing experience, many have advanced degrees, and the depth of experience encompasses multiple therapy areas.

Regulatory Sciences icon

SCALABLE

With access to a large pool of experienced medical writing resources, we can scale up as needed to accommodate any demand.

Submissions icon

QUALITY FOCUSED

We believe quality is intentional. Using a documented and systematic approach, we build quality into each document as it evolves through its lifecycle.

Full Service Clinical Trials icon

ADEPT PROJECT AND STAKEHOLDER MANAGEMENT

With experience managing deliverables from start to finish, we autonomously coordinate all aspects of input, production, and review of every document while skillfully collaborating with global, cross-functional teams.

Our Medical Writing Portfolio

Our medical writing portfolio encompasses execution of hundreds of deliverables spanning all types of clinical, safety, and other scientific communication documents, including but not limited to:

Clinical

  • Clinical Study Reports (CSRs)
  • Protocols and Protocol Amendments
  • Investigator’s Brochures (IBs) and IB Updates
  • Regulatory Submission Summary Documents (IND/NDA/MAA/CTA)
  • Responses to Questions (RTQs)/Regulatory Responses (across multiple health authorities)
  • Pre-Meeting Packages/Briefing Packages
  • Orphan Drug Applications
  • Pediatric Investigation Plans
  • Pediatric Study Plans (including waivers)
  • Health Outcomes Economics/Real World Evidence Documents
  • Fast Track Designation
  • Orphan Drug Designation (ODD) Application/Annual Reports
  • Immunogenicity Reports
  • Ethnic Sensitivity Reports
  • Conditional Marketing Authorization (CMA)
Healthcare workers sitting at table working on tablet devices
Group of professionals collaborating at board

Safety

  • Development Safety Update Reports (DSURs)
  • Periodic Benefit Risk and Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Risk Management Plans
  • Assessment of Benefit Risk (ABR)
  • Annual Reports
  • Patient Safety Narratives

Nonclinical

  • Pharmacology, Pharmacokinetic, and Toxicology Reports (in vivo/in vitro)
  • Bioanalytical Reports

Diagnostics

  • Protocol Proposals
  • Clinical Validation Plan/Clinical Performance Plan
  • Clinical Validation Report/Clinical Performance Report
  • Clinical Study Protocols (CSPs)
  • Clinical Study Reports (CSRs)
  • Intended Use Statements
  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER)
  • State-of-the-Art Determination (SOTA)
  • Scientific Validity Report (SVR)
  • Medical Assessment
  • Medical Opinion Documents
Team of writers collaborating at desk
Professional woman holding stack of folders and small cup

Devices

  • Clinical Evaluation Plans (CEPs)
  • Clinical Evaluation Reports (CERs)
  • Investigational Device Exemption (IDE)

Publications

  • Scientific Manuscripts/Abstracts
  • Posters
  • Literature Reviews/Summaries
  • Oral Presentations

Other Scientific Documents

  • Plain Language Documents (protocol synopses, results summaries)
  • Informed Consent Forms (ICFs)
  • Regulatory White Papers
  • Consumer Health Product Documents

Medical Writing Services  Frequently Asked Questions

Click on frequently asked questions about ProPharma's medical writing services and experience.

We provide medical writing services to pharmaceutical/biotech companies of all sizes (including small, mid-size, and big pharma).

The ProPharma medical writing process is an "author-driven" process that can be modified and customized to meet specific client needs. Our overall goals for each deliverable are to meet timelines, manage challenges, produce a high-quality document, and minimize cost.

At kickoff, the medical writer helps to develop the document timelines, establish team expectations and document strategy, identify potential risks, and establish a risk management plan if needed. During document development, the medical writer collects study documents, collaborates with the authoring team on document content and quality, and follows the communication plan.

The medical writer manages the document review cycles, including comment incorporation and adjudication in collaboration with the authoring team, ensures timeline integrity, and facilitates quality control (QC) reviews, final document approval, and electronic publishing, as necessary.

Yes, ProPharma medical writers collaborate closely with global cross-functional teams during all stages of document development, engaging at a level that meets each individual client’s needs.

In addition to content development, ProPharma writers are also trained to support publications strategy and project management. Our writers will drive timelines, manage meetings, and coordinate with both internal sponsor partners and external KOLs. They can assist your team with everything from researching target journals to creating graphics. They will proactively review Rules for Authors to ensure adherence to the guidelines and can also manage the journal submission. Our team is flexible in providing whatever services you need to support your publications.

ProPharma recruits and retains experienced medical writers, with routine training on our internal policies, SOPs, and work practice documents. Training on client-specific processes is provided as needed. Medical writing leadership mentors the medical writing staff to ensure consistency in performance, communication, and project/time management. Senior/peer reviews of documents provide continuous learning opportunities for writers to ensure quality and internal consistency of our work product. We designate document-specific SMEs who are available to answer questions about process, timelines, documentation, and best practices. We work together to answer questions internally to provide learning opportunities and minimize any interruption or burden on our clients.

ProPharma has also developed an extensive early talent and training program that provides hands-on, mentor-driven medical writing training and support for those interested in becoming medical writers. The foundational training program provides core knowledge and soft skills training (e.g., stakeholder management, communication, teamwork/collaboration, time/project management) through document-specific curriculum, hands-on exercises, shadowing, and direct mentoring designed to accelerate the learning curve and train the next generation of medical writers.

Have additional medical writing questions?

We'd be happy to talk with you about your unique needs and goals.

News & Insights

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

February 2, 2026

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

Explore how AI is transforming pharmacovigilance while ensuring patient safety, data integrity, and regulatory compliance with insights from the 2025 CIOMS report.

Preparing for eCTD 4.0: What FDA Submitters Need to Know

January 29, 2026

Preparing for eCTD 4.0: What FDA Submitters Need to Know

eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance

January 26, 2026

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...

Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

January 27, 2026

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...

ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.

ProPharma Expands Operations with New Office in Hyderabad

December 11, 2025

ProPharma Expands Operations with New Office in Hyderabad

ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

December 4, 2025

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Case Study High-Volume Global Pharmacovigilance Onboarding - ProPharma

January 30, 2026

High-Volume Global Pharmacovigilance Onboarding

A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding...

Case Study Stabilizing High-Volume Legal Case Processing Through Structured Governance - ProPharma

January 28, 2026

Stabilizing High-Volume Legal Case Processing Through Structured Governance

ProPharma’s client faced escalating operational risk as high-volume legal case documentation overwhelmed their prior vendor. Thousands of documents, missed regulatory timelines, and a surge of...

Case Study Overcoming Operational Hurdles in a High-Stakes Stroke Trial - ProPharma

December 15, 2025

Overcoming Operational Hurdles in a High-Stakes Stroke Trial

Argenica Therapeutics’ Phase 2 acute ischaemic stroke trial faced the challenges of unpredictable patient presentation, narrow treatment windows, and demanding emergency care environments. This...

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

March 12, 2026

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

Uncover the intricacies of Pharmacovigilance System Master File (PSMF) management and explore proven strategies to ensure inspection readiness, effective MAH oversight, and regulatory compliance...

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

February 17, 2026

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

With promotional scrutiny increasing around areas such as social media, influencer campaigns, direct-to-consumer (DTC) messaging, and data-driven claims, the session walks through the characteristics...

Scaling High-Quality Medical Information Through Offshoring

February 11, 2026

Scaling High-Quality Medical Information Through Offshoring

Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an...

News & Insights

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

February 2, 2026

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

Explore how AI is transforming pharmacovigilance while ensuring patient safety, data integrity, and regulatory compliance with insights from the 2025 CIOMS report.

Preparing for eCTD 4.0: What FDA Submitters Need to Know

January 29, 2026

Preparing for eCTD 4.0: What FDA Submitters Need to Know

eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance

January 26, 2026

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...

Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.

Previous Post Arrow Next Post Arrow
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

January 27, 2026

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...

ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.

ProPharma Expands Operations with New Office in Hyderabad

December 11, 2025

ProPharma Expands Operations with New Office in Hyderabad

ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

December 4, 2025

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study High-Volume Global Pharmacovigilance Onboarding - ProPharma

January 30, 2026

High-Volume Global Pharmacovigilance Onboarding

A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding...

Case Study Stabilizing High-Volume Legal Case Processing Through Structured Governance - ProPharma

January 28, 2026

Stabilizing High-Volume Legal Case Processing Through Structured Governance

ProPharma’s client faced escalating operational risk as high-volume legal case documentation overwhelmed their prior vendor. Thousands of documents, missed regulatory timelines, and a surge of...

Case Study Overcoming Operational Hurdles in a High-Stakes Stroke Trial - ProPharma

December 15, 2025

Overcoming Operational Hurdles in a High-Stakes Stroke Trial

Argenica Therapeutics’ Phase 2 acute ischaemic stroke trial faced the challenges of unpredictable patient presentation, narrow treatment windows, and demanding emergency care environments. This...

Previous Resource Arrow Next Resource Arrow
Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

March 12, 2026

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

Uncover the intricacies of Pharmacovigilance System Master File (PSMF) management and explore proven strategies to ensure inspection readiness, effective MAH oversight, and regulatory compliance...

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

February 17, 2026

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

With promotional scrutiny increasing around areas such as social media, influencer campaigns, direct-to-consumer (DTC) messaging, and data-driven claims, the session walks through the characteristics...

Scaling High-Quality Medical Information Through Offshoring

February 11, 2026

Scaling High-Quality Medical Information Through Offshoring

Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an...

Previous Webinar Arrow Next Webinar Arrow