medical writing services
An industry leader in providing global, strategic, responsive, and flexible medical writing project support.
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
September 27, 2023
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...
September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
September 21, 2023
Meet the Expert: Kamila Rocha
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
News & Insights
September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
