Pharma Regulatory Legal Services

We provide legal support to all our clients for all the matters related to Drugs, Food, Medical devices and Cosmetics

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With so many applicable laws on pharmaceutical manufacturing and sale and their non-uniform implementation, enforcement and understanding leads to a situation where a manufacturer or distributor finds himself in legal issues. Current Indian laws are very stringent and are supported with very strong penal actions which may include fines, product ban, cancellation or suspension of licenses and imprisonment.

Hence, it is very important to understand the laws properly and avoid any kind of unwarranted legal trouble. However, in the face of such a situation then it has to be handled meticulously.

We at API First have a network of legal experts across India who are well versed with the laws and have vast experience in handling such cases. Our team of technical experts also helps our legal team in understanding the technical aspects of the case. Hence, a combination of technical and legal experts helps our clients to fight their case better.

Our team of experts help the client in framing replies to the show cause notices, Not of Standard Quality (NSQ) letters or any other legal notices issued by the Drug Authorities or any other Government departments.

The legal experts also represent the clients in courts if any need arises.

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API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.