Our Services
- Legal services in the matter of the drug laws in India like Drugs and Cosmetics Act, 1940 and Rules, 1945, Medical Devices Rules, 2017, New Drugs and Clinical Trial Rules, 2019, Drugs (Prices Control) Order, 2013, 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, etc.
- 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
- 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.
- Recommendations on Infrastructure changes, preparing the plan layouts, facility requirements.
- Support for documentation review, changes.
- Improving on Quality Management System.
- Training of management staff and workmen on data integrity, documentation, basic GMP, Quality Management System, Qualifications & Validations & how to face audits etc.
- Help in investigations and preparation of CAPA.
- Keeping updates with recent trends, updates related to GMP, QMS of API Industry.