Mir Shahroz

Mr. Mir Shahroz

Regulatory affairs

Biography

Total professional Experiences: More than 16 years Industrial experiences Department: Regulatory affairs He has successfully filed and got approval for more than 45 ANDAs – US-FDA (Complete product lifecycle), 100 MAs-Europe (Complete product lifecycle) and More than 1000 Product dossiers filed and got approval from Different countries (ASEAN, CIS, EAC, MENA etc.) till date. During approval process of Drug products/cGMP-Facilities, he did a technical communication with several Regulatory Agencies Like, USFDA, UKMHRA, SULK, ANSM, CBG, other EU regulatory Agencies. He is expert in establishment of departments (Regulatory affairs/Pharmacovigilance/QA) through building the system SOPs/Training and evaluate its effectiveness for continual improvement. He is expert in giving the regulatory solution to company to launch the potential products in least minimum time.

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