##  [Regulatory Medical Writing Services](/index%2ephp/medicinal-products/regulatory-medical-writing-services) 

# Regulatory Medical Writing Services

Unlock success in documentation with Freyr's Regulatory medical writing services right before the submissions. From Clinical overviews to Risk Assessment reports, we ensure precision and compliance with global Regulatory standards.





- 60
    
    \+
    
    
    
    Experts
- 20
    
    \+
    
    
    
    Years of Domain Expertise
- 150
    
    \+
    
    
    
    Customers/Clients
- 150
    
    \+
    
    
    
    Dossiers Prepared for NDAs, BLAs, MAAs, and 505 b(2)s
- 2500
    
    \+
    
    
    
    PDE & OEL Reports
- 500
    
    \+
    
    
    
    Impurities risk assessments
- 50
    
    \+
    
    
    
    ERA as per EMA 2024 requirements











- [Overview](#overview)
- [Services](#services)
- [Expertise & Advantages](#expertise)
- [Success Stories](#success-stories)
- [Testimonials](#testimonial)
- [Insights](#insights)







## Regulatory Medical Writing Services - Overview



Medical writing is an indispensable aspect of any Regulatory submission for Pharmaceuticals. Handing clinical and non-clinical modules for Regulatory submission dossiers under medical writing requires an in-depth understanding, experience, and thorough Regulatory knowledge.

Freyr is a significant player in Regulatory Medical Writing Services and has expertise through a team of highly qualified medical writing professionals. Our well-established processes, governed by SOPs, checklists, and reviews, ensure high-quality documents are maintained. Our Regulatory medical writing team is flexible and adapts to client-specific processes and templates for document development. Such alignment among experts based on project-specific requirements ensures better time management during project completion.

Our Regulatory writing services team is equipped to work with the US, EU, UK, and other regulated and semi-regulated countries.













## Freyr’s Regulatory Medical Writing Services



##### MPR - Medical Writing Menu Block 

- [Clinical Services](/index%2ephp/medicinal-products/clinical-writing-services)
- [Non-Clinical Writing Services](/index%2ephp/medicinal-products/non-clinical-writing-services)
- [Regulatory Toxicology Services](/index%2ephp/medicinal-products/regulatory-toxicology-services)
- [Clinical and Non-Clinical Consulting and Strategic Services](/index%2ephp/medicinal-products/clinical-and-non-clinical-consulting-and-strategic-services)
- [Automation in Medical Writing](/index%2ephp/medicinal-products/automation-in-medical-writing)
 
 









## Regulatory Medical Writing Services



- [Expertise](#mdv-1)
- [Advantages](#mdv-2)

- Preparation and review of Non-Clinical and Clinical Overviews and Summaries (eCTD Modules 2.4, 2.5, 2.6, and 2.7), including the preparation and review of eCTD Modules 4 and 5
- Preparation and review of the Clinical Study Report (CSR, eCTD Module 5)
- Preparation and review of the Clinical Trial Protocol (CTP), Investigator Brochure (IB), efficacy and safety summaries, and patient/safety narrative writing
- Support for Integrated Summaries (ISS, ISE, and ISI)
- Clinical justification documents for the EU, US, and other emerging Regulatory markets
- Biowaiver support for product approval and strategic support for study design
- Abuse liability assessment justification support
- Clinical (GCP) and bioanalytical (GLP) facility audits provide expertise and support for study-specific monitoring
- Toxicological Risk Assessment (TRA) of impurities, extractables and leachables, excipients, and industrial chemicals
- Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) calculations



![Regulatory Medical Writing Services]()





- A team of over sixty (60) clinical and non-clinical medical writing experts
- In-depth Regulatory medical writing knowledge, like the ICH-GCP, EMA, and FDA guidelines, with IT capabilities integration
- Vast experience in multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
- Defined processes of thorough scientific, medical, editorial, and in-house quality control review before the sponsor review
- Experience in drafting medical writing documents for various phases of clinical development, including Phase I to IV, Post-Marketing Surveillance Studies (PMS), and Post-Authorization Safety Studies (PASS)
- Timely delivery of medical writing documents with the highest standard of quality



![Regulatory Medical Writing Services]()













#### Precise Regulatory Writing Starts Here

[Get Started with Freyr](javascript:void(0))