We provide assistance in filing application for regulatory approvals and procuring approvals from any regulatory body in India. We advise clients regarding compliance requirements needed for their business and alert them about latest regulatory policy updates. Our attorneys hold expertise in handling regulatory affairs in pharmaceutical, cosmeceutical and food industry
Central Drugs Standard Control Organisation (CDSCO) Registrations:
We assist importers, manufacturers, exporters of drugs and cosmetics, Pharma R & D firms, Ethics committee, Labs and sponsors involved in drugs testing / conducting BA and BE studies and Blood bank for registering in CDSCO. We provide assistance for obtaining approval of new drugs, approval for conduct of clinical trials in India, Cosmetic Registration, Medical Devices Registration, import/manufacture license for Medical devices, registration of In-vitro diagnostics kits (IVD kits) and registration of blood products.
Food Safety and Standards Authority of India (FSSAI) License:
We assist food manufacturers, distributors, restaurants, importers, exporters, any food businesses, dairy farms, food processors for procuring FSSAI License. Based on their business turnover, we suggest whether they should go for Basic, State or Central license. We assist in filing of required forms to the local Food Business Operator.
National Biodiversity Authority (NBA) Approvals:
We assist Indian entities & researchers, foreign companies & researchers for obtaining permission from NBA for initiating research or commercial utilization of any biological resource from India including plant, animal and microorganisms or parts thereof. We also help inventor who files patents for invention based on any research on a biological resource from India for obtaining permission from NBA.