Regulatory Services
Navigating the complex landscape of regulatory approvals is critical to bringing pharmaceutical products and medical devices to market. Our experienced regulatory affairs team provides comprehensive support to ensure a seamless and efficient submission process. We specialize in:
- Marketing Authorization Applications (MAAs): Preparing and submitting dossiers for new pharmaceutical products, generics, biologics, vaccines, and medical devices, adhering to global standards such as the Common Technical Document (CTD) format and regional requirements (e.g., DPML in Cameroon).
- Variations and Post-Approval Changes: Managing amendments to existing approvals, including labeling updates, formulation changes, or manufacturing process modifications, ensuring compliance and minimal disruption.
- Clinical Trial Applications (CTAs): Supporting the design and submission of clinical trial protocols, coordinating with ethics committees, and ensuring alignment with Good Clinical Practices (GCP).
- Pharmacovigilance and Safety Reporting: Assisting with adverse event reporting, risk management plans, and post-market surveillance to meet regulatory obligations and safeguard patient safety.
Our team leverages strategic insights and meticulous attention to detail to streamline approvals, reduce timelines, and ensure compliance with national and international regulatory bodies.
Address:
66 Broklyn Street, New York
Email:
mail@example.com
Open Hours:
Mon-Sat: 9am - 6pm