Regulatory Writing Services

Unlock the pathways to your successful regulatory documentation with Freyr's expert Medical Writing Services right before the submissions. From clinical overviews to risk assessment reports, our team ensures precision and compliance with global Regulatory guidelines. Partner with us for seamless documentation and unparalleled quality.

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Regulatory Medical Writing Services - Overview

Regulatory medical writing is an indispensable aspect of any Regulatory submission for Pharmaceuticals. Developing accurate clinical and nonclinical documents for Regulatory submission dossiers under medical writing requires an in-depth understanding, experience, and thorough knowledge of the Regulatory guidelines.

Freyr is a significant player in Regulatory medical writing services and has vast expertise due to a team of highly qualified medical and scientific writing professionals. At Freyr, well-established processes governed by SOPs, checklists, and reviews ensure that high-quality documents are maintained. Our Regulatory medical writing team is also flexible in adapting to client-specific processes and templates for the development of any documents. The alignment of medical writing experts and other team members based on project-specific requirements ensures better time management through an efficient transition to project completion.

Our medical writing team is well-versed in dealing with submissions for the US FDA, EMA, MHRA, and other regulated and semi-regulated countries.

Regulatory medical writing services at Freyr include the following:

  • Clinical Services
  • Non- Clinical Services
  • Scientific Writing Services
  • Ad-Promo Services

Regulatory Medical Writing Services

  • Strategic Regulatory writing support for clinical and nonclinical development according to the submission type and Regulatory authority.
  • Preparation and review of nonclinical & clinical overviews and summaries (eCTD Module 2.4, 2.5, 2.6, and 2.7), including the preparation and review of eCTD Modules 4 and 5.
  • Preparation and review of Clinical Study Report (CSR, eCTD Module 5).
  • Preparation and review of Clinical Trial Protocol (CTP), Investigator Brochure (IB), efficacy and safety summaries, and patient/safety narrative writing.
  • Support on 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 expertise and support in study-specific monitoring.
  • Toxicological Risk Assessment (TRA) of impurities, extractables & leachable, excipients, and industrial chemicals.
  • Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) calculations.
  • Scientific writing services like publications, abstracts, posters, brochures, presentations, literature searches, and reviews.
  • Ad-Promo services like the Regulatory and medical reviews of advertising and promotional materials.
  • A holistic review of promotional products with compliance management.
  • A team of over forty (40) medical writing experts, which includes clinical, nonclinical, and scientific writers.
  • In-depth Regulatory medical writing knowledge like the ICH-GCP, EMA, and FDA guidelines perfectly integrated with IT capabilities.
  • Complete understanding of the complex drug development process, including NCEs, generics, biologics, and biosimilars.
  • Vast experience in working across 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).
  • Well-versed in working with various stakeholders alongside Regulatory medical writing teams like clinical operations, data management, biostatistics, medical, and safety to deliver documents.
  • Submission-ready medical writing documents in terms of technicalities, language, format, and templates used to prepare the documents.
  • Timely delivery of medical writing documents with the highest standard of quality.

Ready to elevate your medical content? Our experienced team of medical writers is here to deliver exceptional results. Reach out to us now and let's discuss how we can meet your specific medical writing needs

Contact Freyr

Partnering with Leading Organizations

 

Medicinal Products

Medical Writing

India

A big thanks to the Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward to a continuous business association with Freyr.​

Head of Quality Assurance​

India-based, Leading Pharma Contract Manufacturing Organization​

 

Medicinal Products

Medical Writing

India

A big thanks to Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward for a continuous business association with Freyr.

Head of Quality Assurance

 

Medicinal Products

Medical Writing

UK

We are extremely happy to inform you that the BLA was successfully submitted to the FDA. We convey our sincere gratitude to the Freyr team, who worked diligently, tirelessly, and very closely with our Bridgewater and Beijing teams over the past several months to accomplish this monumental feat on time. Freyr’s team went beyond the call of duty to make this BLA submission come true. We truly appreciate Freyr’s flexibility and eagerness to work with us to accomplish aggressive goals. Look forward to your perennial support and our continued relationship and beyond. ​

Global CMC Technical Lead​

China-based, Leading Innovator Pharmaceutical Company​

 

Medicinal Products

Medical Writing

USA

Thank you, Freyr team. I appreciate your professionalism, dedication, and hard work. You’ve gone above and beyond to ensure all deliverables were met ahead of schedule throughout the project and have done a great job managing a challenging group of products. I appreciate your attention to detail and follow-up on the large workload you’ve managed. It’s been a pleasure working with you, and I wish you and your family all the best in the future!​

Director, Global Labeling Management – Labeling Cluster Head Global Product ​ Development, Global Regulatory Affairs

US-based, Multinational Pharmaceutical and Biotechnology Company​

 

Medicinal Products

Medical Writing

Vietnam​

Thank you so much for being a great partner in our Regulatory compliance journey.

As Asian countries move towards having safety assessments as a key requirement, your support has helped us significantly in fulfilling those requirements well ahead of our competitors in Vietnam. ​

In fact, I shared your contact with our regulatory officers so that they can share it across the industry if the safety assessments become necessary.

Lead, R&D/Personal Care

India-based, Multinational Consumer Goods Company​

 

Medicinal Products

Medical Writing

USA

Kudos to you all for the brilliant teamwork !! Alone, we can do so little; together, we can do so much.

Look forward to the next milestone and collaboration on new projects in the future.

SVP - R&D ( Finished Dosage Form)​

US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development​