Prasad Naik
Regulatory Affairs Executive @Perdaman Pharmaceuticals Ltd
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WORK HISTORY
Regulatory Affairs Executive @Perdaman Pharmaceuticals Ltd
Hyderabad, IN
Compilation & Submission of dossier: Compilation and Submission of dossiers in CTD & ACTD format for Finished Pharmacutical Products (Tablets, Capsules & Liquid preparation) of the following countries ASEAN Countries (Srilanka, Myanmar, Cambodia, Vietnam, Philippines and Kazakhstan) African Countries (Botswana, Tanzania, Madagascar, Mozambique and Nigeria) Armenia Latin America: Guatemala.Review and other relevant activities: As per market demands compilation, review and submission of CTD and ACTD format dossiers (for tablets, capsules and Liquid preparation) to agents/customers, as well as responsible for query responses and pending documents submission in order to get the approvals. Submission of Variation dossiers Review of documents like BMR, BPR, PV, AMV, CDR, BA/BE Reports, PDR and all other Technical documents before submission to minimize the queries. Maintenance of soft and hard copies, registration status and records. Co-ordination with all departments like QA, FR & D, QC, Packaging and Production department, as well as CRO’s. Coordinating with customer/agent to clarify the queries raised by MOH. Respond to Queries. Art Work Development:• Review of Artworks. • Preparation and review of Patient Information Leaflet (PIL), Pack insert and SmPC.
EDUCATION
Acharya Nagarjuna Vishwavidhyalayamu
Bachelor of Pharmacy (B.Pharm.)
Andhra University
M Phrmacy
SKILLS
ABOUT PRASAD NAIK
BUSINESS AND PHARMACIST
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