Regulatory Writing Services

Expert Regulatory Documentation for Global Compliance and Approval

Regulatory writing is a critical component of the drug, biologics, and medical device approval process, ensuring that clinical and non-clinical data are accurately documented, interpreted, and presented in compliance with global regulatory requirements. At Clievi, we offer end-to-end regulatory writing solutions tailored to the guidelines of regulatory authorities such as the FDA, EMA, MHRA, Health Canada, PMDA, and ICMR.

Our regulatory writing services include clinical trial documentation, regulatory submission dossiers, pharmacovigilance reports, and post-marketing regulatory support, ensuring clarity, compliance, and scientific integrity throughout the drug development and approval lifecycle.

Our Comprehensive Regulatory Writing Services

1. Clinical Regulatory Writing Services

We provide clinical trial documentation to support Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA).

• Clinical Study Protocols (CSPs): ICH-compliant protocols outlining study objectives, design, methodology, endpoints, and statistical analysis plans (SAPs).
• Investigator’s Brochures (IBs): Concise summaries of preclinical and clinical data to guide investigators in trial execution.
• Clinical Study Reports (CSRs): ICH E3-compliant CSRs summarizing safety, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) outcomes.
• Informed Consent Forms (ICFs): Regulatory-compliant, patient-friendly ICFs for ethical and transparent clinical trial participation.
• Patient Narratives & Safety Summaries: Clear, structured summaries of adverse events (AEs) and serious adverse events (SAEs) for regulatory filings.

2. Regulatory Submission Dossiers

Our team prepares regulatory submission documents compliant with ICH, eCTD, and country-specific regulatory frameworks.

• Common Technical Document (CTD) & eCTD Dossiers:
  • Module 2: Summary of Clinical and Non-Clinical Data
  • Module 3: Quality & CMC (Chemistry, Manufacturing & Controls) Data
  • Module 5: Clinical Study Reports and Statistical Analysis
• Investigational New Drug (IND) & New Drug Application (NDA) Submissions: End-to-end IND/NDA documentation with data interpretation and submission readiness checks.
• Biologics License Application (BLA) Documentation: Clinical, non-clinical, and manufacturing documents for biologics regulatory approvals.
• Medical Device Regulatory Submissions: 510(k), De Novo, PMA, and CE Marking (EU MDR 2017/745) dossiers for medical device compliance.
• Orphan Drug & Paediatric Investigation Plans (PIP): Expert documentation for orphan drug designation (ODD) and pediatric study plans to meet global regulatory requirements.

3. Pharmacovigilance & Safety Writing

Ensuring post-marketing compliance and safety monitoring with comprehensive risk-benefit analysis and pharmacovigilance reporting.

• Periodic Safety Update Reports (PSURs) & Periodic Benefit-Risk Evaluation Reports (PBRERs): Post-marketing safety reports complying with ICH E2E and EMA GVP guidelines.
• Development Safety Update Reports (DSURs): Continuous safety monitoring reports for ongoing clinical trials, compliant with ICH E2F.
• Risk Management Plans (RMPs): FDA REMS & EMA RMP documentation for assessing drug safety and mitigation strategies.
• Post-Marketing Surveillance (PMS) Reports: Phase IV & real-world evidence (RWE) safety data analysis to monitor long-term product safety.
• Serious Adverse Event (SAE) & Individual Case Safety Reports (ICSRs): Narrative writing for clinical trial and post-marketing safety cases.

4. Non-Clinical & Preclinical Regulatory Writing

Our non-clinical writing team specializes in toxicology, pharmacology, and preclinical study documentation to support early-phase drug development.

• Non-Clinical Study Reports (NSRs): Summary of in vivo and in vitro toxicology, safety pharmacology, and ADME (Absorption, Distribution, Metabolism, and Excretion) studies.
• Investigator’s Brochure (IB) – Non-Clinical Section: Compiling preclinical safety and efficacy data for clinical investigators.
• Toxicology Study Reports: Preparing GLP-compliant documentation on animal toxicology findings for regulatory review.
• Preclinical Data Summary Reports: Translational research documentation for early-stage drug development decisions.

5. Medical Device & In Vitro Diagnostics (IVD) Regulatory Writing

Regulatory compliance for medical devices and diagnostics is critical for global market entry. We provide:

• Clinical Evaluation Reports (CERs) & Performance Evaluation Reports (PERs): EU MDR/IVDR-compliant documentation for medical devices and diagnostics.
• Device Risk-Benefit Assessments & Safety Reports: Human factors analysis, biocompatibility summaries, and usability risk assessments.
• 510(k), De Novo, and PMA Submissions: U.S. FDA documentation for medical device clearances and approvals.
• Medical Device Clinical Investigation Plans (CIP): Structuring study designs for ISO 14155 and FDA CFR Part 812 compliance.

Why Choose Clievi for Regulatory Writing Services?

• Global Regulatory Expertise: Proven experience in FDA, EMA, MHRA, Health Canada, PMDA, TGA, and WHO submissions.
• Compliance-Driven Approach: ICH, GCP, GVP, ISO 14155, and CFR compliance for regulatory document preparation.
• Multi-Therapeutic Area Experience: Expertise in oncology, neurology, cardiology, rare diseases, infectious diseases, and more.
• Seamless Integration with Biostatistics & Data Science: Ensuring data-driven regulatory documentation backed by real-world evidence (RWE) and statistical modeling.
• End-to-End Support: From preclinical to post-marketing regulatory documentation, we offer full lifecycle regulatory writing services.

Get Started with Clievi’s Regulatory Writing Services

Ensure regulatory approval, compliance, and scientific accuracy with Clievi’s expert regulatory writing services. Contact us today to discuss your clinical, preclinical, and post-marketing regulatory documentation needs.