REGULATORY AFFAIRS
Our Medical & Regulatory affairs team are up to date with the latest pharmaceutical and healthcare practices to ensure consistency with the most recent guidelines, regulations and clinical publications.
This includes;
- Preparation and submission of clinical trial applications, regulatory submissions and correspondence to various regulatory agencies on behalf of sponsor
- Obtaining approval for new pharmaceutical products and medical devices as well as changes for approved products
- Common Technical Dossier (CTD) and ASEAN Common Technical Dossier (ACTD) dossier review and gap analysis identification
- Creation of regulatory standard operating procedure (SOP) documents.
- Advice and development of regulatory affairs filing strategy