Medical Writing Services

Regulatory Medical Writing Services

Medical writing is a fundamental need in the pharmaceutical and biotechnological industries, essential throughout the lifecycle of a product—from clinical development and regulatory submissions to safety assessments and post-market surveillance. DDReg’s specialized medical writing services address the multifaceted challenges associated with regulatory and safety documentation, including navigating ever-evolving regulations, analyzing complex data, and ensuring effective risk communication.

Regulatory and Safety Writing Solutions

Our regulatory writing services are designed to meet the highest standards of quality and compliance. We specialize in the creation of crucial documents such as:

• Clinical and nonclinical sections of the eCTD (Modules 2.4 to 2.7)
• Product labels (SPC/PIL/PIs)
• Biowaiver justifications
• Product reviews
• Pharmacoeconomic write-ups
• Clinical study reports
• Study protocols
• Investigator’s brochures
• Annual safety reports
• Development Safety Update Reports (DSURs)
• Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Periodic Adverse Drug Experience Reports (PADERs)

These documents are essential for regulatory submissions and require a deep understanding of regulatory guidelines, extensive experience, and an in-depth knowledge of the dynamic regulatory landscape.

Why Choose DDReg for Safety and Regulatory Writing Services?

Our Expertise and Excellence in Medical Writing

With over 14 years of experience, DDReg has established itself as a premier provider of regulatory medical writing services globally. Our team consists of highly qualified medical and scientific writing professionals dedicated to delivering documents of the highest quality and scientific rigor. Our success is built on:

• Extensive industry and subject-matter expertise
• Experience with over 120 regulatory agencies
• Robust processes governed by Standard Operating Procedures (SOPs), checklists, and thorough reviews
• Compliance with international standards and guidelines

Client-Focused Approach

Our medical writing consultant team integrates client-specific processes and templates to produce precise and accurate documents. We work closely with the Regulatory Affairs and Pharmacovigilance departments to ensure timely project completion and optimal time management. Our capabilities include:

• Developing and reviewing documents essential for clinical development, regulatory submissions, drug safety, and pharmacovigilance
• Gathering relevant information from diverse sources such as scientific literature and safety data
• Drafting, compiling, and rigorously reviewing a wide array of documents

Global Reach

DDReg has a proven track record of collaborating with leading global organizations, including pharmaceutical companies, Contract Research Organizations (CROs), and Biotechnology firms. We support submissions to stringent regulatory authorities such as the US FDA, EMA, UK MHRA, PMDA, Health Canada, and authorities in emerging markets (LatAM, CIS, MENA, GCC, ASEAN, ANZ). Our team undergoes thorough scientific, editorial, and quality control reviews to ensure all documents meet the highest standards.

DDReg offers a diverse range of medical writing solutions throughout all stages of the product lifecycle:

Clinical Development Plan & Documentation:

Regulatory Filing and Submission:

Post Approval & Life Cycle Management: