Experienced. Focused. Reputation.
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Food and Drug Administration, Maharashtra State
Pharmalex is providing legal advice to all major Pharmaceutical Industry Associations and many leading pharmaceutical companies. The clients include multinational companies, medium scale and small scale industries. The list of major clients to whom legal advice is provided either on retainership basis or on case to case basis is as under:-
Legal advice in the matter of issues arising out of compliance of the drug laws in India like Drugs and Cosmetics Act, 1940 and Rules, 1945, Drugs and Magic Remedies [Objectionable Advertisements] Act. 1954 and Rules, 1955, Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules related to manufactured drugs, Psychotropic Substances and Controlled Substances, Drugs (Prices Control) Order, 2013 etc
Technical guidance in routine regulatory activities where Regulatory Affairs face the challenges due to different interpretation of the provisions under the above said Acts and Rules.
Technical audits of manufacturing sites and distributors, warehouses to assess compliance of drug legislations in India and provide advice on Corrective And Preventive Action [CAPA].
Training for professionals in pharmaceutical industry, distribution network and community pharmacist to sensitize them about drug legislation in India for better compliance.
Providing opinion on the specific issue raised by the regulatory authorities, drafting response to the issues raised by regulatory authorities.
Drafting of appeal against the order of licensing authorities
PHARMALEX
1601, 'B' Wing, Gurukrupa Nirmalam, Khernagar, Bandra (E), Mumbai – 400 051
+91 9987173651
Mon-Fri 11am- 5pm