- Keen Knowledge on Regulatory guidelines for finished product registration.
- Dossier compilation as per guidelines.
- Compilation and review the product dossiers for submission in CTD, ACTD.
- Gap analysis of the dossier and addressing the gaps before submission to MOH.
- Handling the customer and MOH queries.
- Life cycle management of the product.
- Development report, scale up report, specification, COA, stability protocol and Process validation protocol.
- Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability).
- Post approval experience to file the applicable variations timely.
- Knowledge on EAEU, ICH and EMEA guidelines.
- Re-registration (Renewal) procedures.
- Administrative documents requirements (COPP, Mfg. License and Import License) .
- Registration information management system updates on regular basis.