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.
Benefits of Working with Our Medical Writing & Editing Team
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.
SCALABLE
With access to a large pool of experienced medical writing resources, we can scale up as needed to accommodate any demand.
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.
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)
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
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
News & Insights
July 28, 2025
Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market
Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...
July 25, 2025
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).
July 24, 2025
FDA Publishes over 200 Complete Response Letters (CRLs)
FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.
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News & Insights
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma 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.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
