Strategic Regulatory Services
Our regulatory services include:
- Marketing Authorization Application (MAAs): Preparing and submitting dossiers for new pharmaceutical products (generics. OTCs, biologics, biosimilars, vaccines), nutraceuticals products and medical devices. We understand and adhere to global standards as well as the local regulatory requirements of the country.
- Variations and Post-Approval Changes: We manage amendments to existing approvals. These include manufacturing site, labelling update, formulation changes, manufacturing process modifications to ensure compliance and minimal disruptions.
- Clinical Trial Applications (CTAs): We support the design and submission of clinical trial protocols, coordinate to get the Ethical Review Board approvals and ensure alignment with Good Clinical Practices (GCP).
- Pharmacovigilance and Safety Reporting: We manage adverse event reporting, risk management plans, and post marketing surveillance to meet post-approval 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:
Carrefour Claritaine - Nkolbisson, Yaounde - Cameroon
Email:
info@teakpharma.com