GIRIVAR DHARI
Regulatory Affairs at Somerset Therapeutics Limited- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Location
Bengaluru, Karnataka, India, IN
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Experience
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Somerset Therapeutics Limited
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India
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Regulatory Affairs
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Feb 2020 - Present
- Preparation of ANDA for parenteral dosage forms (Injections & Ophthalmics) - Handling of post-approval Activity (Annual Report, PADERs, CBE0, CBE 30 and PAS). - Handling of deficiencies raised by Regulatory Agency. - Product Life cycle management - Preparation of ANDA for parenteral dosage forms (Injections & Ophthalmics) - Handling of post-approval Activity (Annual Report, PADERs, CBE0, CBE 30 and PAS). - Handling of deficiencies raised by Regulatory Agency. - Product Life cycle management
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