Regulatory Medical Writing

Overview

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

Reg Solutions is a significant achiever in Regulatory Medical Writing and has vast experience and expertise coupled with a team of highly qualified medical and scientific writing professionals. At Fryer, well-established processes governed by SOPs, checklists, and reviews ensure that the quality of documents is maintained at the highest standard. Our team is also flexible in adapting to client-specific processes and templates for the development of any documents. The alignment of experts and other team members based on project-specific requirements ensures better time management through an efficient transition to project completion.

Together, our experts have developed numerous documents for a variety of submissions across the globe. Our team is well-versed in dealing with submissions for the US FDA, EMEA, MHRA, and other regulated and semi-regulated countries.

Full range of MW Services at Reg Solutions

• Clinical Services.

• Nonclinical Services.

• Scientific Writing Services.

• Ad Promo Services.

Reg Solutions Expertise

• Strategic 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.

• Justification for abuse liability assessment.

• Expertise in clinical (GCP) and bioanalytical (GLP) facility audits and support in study-specific monitoring.

• Toxicological Risk Assessment (TRA) of impurities, extractables & leachables, excipients, and industrial chemicals.

• Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) calculations.

• Scientific writing services like publications, abstracts, posters, brochures, PowerPoint presentations, literature searches, and reviews.

• Ad Promo services like the global Regulatory and medical review of advertising and promotional materials.

• A holistic review of promotional products with compliance management.

Reg Solutions Advantages

• A team of over forty (40) clinical and nonclinical experts, including scientific writers.

• In-depth Regulatory 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 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 like clinical operations, data management, biostatistics, medical, and safety teams to deliver documents.

• Submission-ready documents in terms of technical information, language, format, and templates used to prepare the documents.

• Timely delivery with the highest standard of quality.

• Regulatory Medical Writing

  • Regulatory/Medical Review of Ad Promo Material

  • Advertising and Promotional (Ad Promo) Review Services

  • Clinical Services

    • Regulatory Writing Services

    • Clinical Trial and Consulting Services

    • Clinical Trial Audit and Monitoring Services

  • Non-clinical Services

    • Nonclinical Regulatory Writing

    • Permitted Daily Exposure (PDE)

    • Toxicological Risk Assessment (TRA) of Impurities, Extractables & Leachables

  • Scientific Writing

    • Publication Support Services

• Pharmacovigilance

  • ICSR Services

  • Literature Monitoring Services

  • Aggregate Safety Reports

  • Signal Management

  • Risk Management

  • PV Audit and Training

  • Pharmacovigilance Safety Database

  • Medical Device PMS/Vigilance

  • Regulatory Intelligence and Consulting in Pharmacovigilance

  • Quality Control

• Compliance, Audit and Validation

  • GxP Audit Services

  • SOP Writing and SOP Review Services

  • Computer System Validation and Computer System Assurance

  • End-to-End Compliance Services

  • Remote and Virtual Audit

• Spin-offs, Mergers & Acquisitions, and Divestitures (SoMAD) Consulting services