Saravanan Muthiah
Avp-regulatory Affairs at Bafna Pharmaceuticals Limited , India
Based in Ahmedabad, India
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Seniority
Director
Department
Science
Location
Ahmedabad
Industry
Pharmaceutical Manufacturing
Company size
216
Contact information
Reveal Saravanan's email and phone
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s•••••••@bafnapharma.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Saravanan Muthiah
Expertise: Submission of applications for pharmaceutical product registration at various Regulatory Agencies like USFDA, EMA, TGA, WHO, etc. Preparation of acceptable response to comments received from the Agencies. Strong Review in the CMC Sections (especially Specifications, Standard Testing Procedure, Analytical Method Validations, Stability Data, etc.) of an application (CTD, NeeS, eCTD, etc.) Regulatory Project Management/TrackingAudit the Contract Manufacturing/Testing facilities for CGMP Compliance especially in QMS (Change Control, Deviation, CAPA, Market Complaints, etc.).Impart Training in specialized subjects like 21 CFR Part 11, EU GMP Annex11, Data Integrity, Debarment, Size, Shape and Physical Attributes, Requirement on Scored Tablets, IIG, etc. Experience: Earned very good reputation by serving for about 20 years in following Organizations:• Cadila Pharmaceuticals Ltd, Ahmedabad, India.• MicroLabs Ltd, Mumbai & Hosur, India.• Unichem Labs Ltd, Mumbai, India• Glenmark Research Centre, Navi Mumbai, IndiaEducation: A post graduate in Pharmacy (M.Pharm) graduated from Banaras Hindu University (B.H.U.), Varanasi, India Access:Reachable through e-mail: sariya1972@gmail.com; Phone/Mobile:+91-990-948-3835
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