Regulatory Affairs
At WEP, our Regulatory Affairs group provides expert guidance and end-to-end regulatory support to help sponsors navigate the complex global regulatory landscape. We ensure that clinical trials meet regulatory, ethical, and compliance standards from study initiation to final submission, enabling a smooth, efficient, and compliant trial process.
Regulatory Affairs Services at WEP include the following:
Regulatory Strategy & Consulting
- Develop customized regulatory strategies tailored to the trial’s therapeutic area and geographic scope.
- Provide early regulatory assessments to identify potential challenges and mitigate risks.
- Advise on global regulatory requirements (FDA, EMA, MHRA, PMDA, Health Canada, and more).
- Support IND (Investigational New Drug) and CTA (Clinical Trial Application) submissions.
Clinical Trial Applications & Regulatory Submissions
- Prepare and submits Investigational New Drug (IND), Clinical Trial Applications (CTA), and Investigational Medicinal Product Dossiers (IMPD).
- Manage pre-IND and pre-CTA meetings with regulatory agencies to streamline approvals.
- Ensure compliance with ICH-GCP, FDA 21 CFR Part 11, EMA, and other regulatory guidelines.
- Facilitate communication and negotiations with regulatory authorities for fast approvals.
Regulatory Documentation & Medical Writing
Develop and reviews key regulatory documents, including:
- Clinical Study Protocols (CSPs)
- Investigator’s Brochures (IBs)
- Informed Consent Forms (ICFs)
- Clinical Study Reports (CSRs)
- Risk Management Plans (RMPs)
- Common Technical Documents (CTD/eCTD) for regulatory submissions
Ethics & Institutional Review Board (IRB) Submissions
- Prepare and submits documentation for IRB and Ethics Committee (EC) approvals.
- Ensure informed consent documents are ethically and legally compliant.
- Manage ongoing ethics review processes throughout the trial.
Regulatory Compliance & Audit Readiness
- Ensure trials meet regulatory and Good Clinical Practice (GCP) standards.
- Conduct regulatory gap analyses and compliance audits.
- Provide inspection readiness training for sponsors, CROs, and research sites.
- Support regulatory agency inspections, audits, and responses to queries.
Post-Approval & Market Authorization Support
- Prepare New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA).
- Support post-marketing commitments, safety reporting, and Phase IV studies.
- Assist with labeling, pharmacovigilance, and risk mitigation strategies.
Why Choose WEP’s Regulatory Affairs Team?
- Expert Regulatory Guidance: Our team includes former regulatory agency professionals, compliance specialists, and medical writers.
- Global Regulatory Expertise: Extensive knowledge of FDA, EMA, MHRA, Health Canada, PMDA, and other health authorities.
- Seamless CRO Integration: Our regulatory affairs experts will work closely with Clinical Operations, Medical Affairs, and Data Management teams.
- Accelerated Regulatory Approvals: Proactive regulatory planning helps reduce trial delays and optimize approval timelines.
- Full Lifecycle Support: From pre-clinical regulatory strategy to post-market regulatory compliance.