Regulatory & Ethics Approval Support
We provide comprehensive global regulatory expertise to help Sponsors navigate the complex and ever-evolving landscape of clinical trial regulations. Our team of seasoned experts coordinate all aspects of the regulatory process, across every stage of the development journey, providing true end-to-end support. We leverage decades of experience and utilize data-driven strategies to maximize study success.
What We Offer
- Expert-Led Guidance: Our regulatory specialists bring decades of experience in clinical trial approvals and submissions.
- Global Reach, Local Expertise: We understand country-specific regulatory requirements to ensure seamless global trial execution.
- Proactive Risk Management: We identify compliance risks and potential regulatory hurdles early, and mitigate them effectively to avoid costly delays.
- Efficient & Accelerated Processes: Our expertise in regulatory pathways helps expedite approvals and trial initiation.
- Documentation Review and Preparation: We align submission strategies with global requirements by drafting, reviewing, and managing all essential regulatory documents.
- Communication with Regulatory Authorities: WEP has knows when and how best to communicate with regulatory agencies to facilitate dialogue and issue resolution.
Regulatory Solutions that Flex as you Flex
We are committed to providing tailored regulatory solutions that meet local and international requirements and drive overall Sponsor objectives. Because we understand that programs evolve and needs change, we ensure our regulatory teams remain proactive and nimble, offering flexible solutions that can adapt quickly and efficiently throughout the study duration, to keep your project on course for success.
We can assist with the preparation and submission of a full dossier of regulatory documents, including:
- Clinical Trial Authorization/Application/Exemptions (CTA/CTX)
- Clinical Trial Notifications (CTN)
- Common Technical Document (CTD)
- Investigational Drug Exemptions (IDE)
- Investigational New Drug Applications (IND)
- Marketing Authorization Applications (MAA)
- New Drug Applications (NDA)
- Biologics License Application (BLA)
- Abbreviated New Drug Application (ANDA)