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Pharm Astute

Pharm Astute is a proprietary concern of Nilesh Gandhi

Services

Legal services in the matter of the drug laws in India like Drugs and Cosmetics

Technical guidance in the activities where the challenges due to different interpretation of the provisions under the above said Acts and Rules are faced.

Provide legal opinion on issues pertaining to the drug laws and drafting response to the issues raised by regulatory authorities.

Drafting of appeal against the order of licensing authorities

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About Pharm Astute

Pharm Astute is a proprietary concern of Nilesh Gandhi and is in existence from December, 2018. Nilesh Gandhi voluntarily retired from FDA, Maharashtra as the Assistant Commissioner (Drugs). He is Bachelor in Pharmacy and Law. He has 4 years experience in manufacture of Pharmaceutical Products and 26 years of outstanding service in FDA, Maharashtra in enforcement of drug regulations. PHARM ASTUTE offers comprehensive legal services in drug legislations. It assists pharmaceutical manufacturers, distributors and retailers in compliance of requirements under the drug laws in India. Pharm Astute is providing legal services, trainings, pre-audits, regulatory compliance support to many leading pharmaceutical companies.

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