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Client:

Robert Downey, Jr.

Case Category:

Banking and Finance

Time Frame:

60 Days

Status:

Win

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The healthcare and pharmaceutical sectors in India are heavily regulated, with stringent requirements for drug approvals, patents, and clinical trials.

  • Regulatory Expertise: We assist pharmaceutical companies in navigating the Drugs and Cosmetics Act, 1940, including obtaining approvals from the Central Drugs Standard Control Organization (CDSCO) for drug manufacturing, marketing, and distribution.
  • Patent and IP Law: Our firm advises on patent protection for new drug formulations and assists in enforcing IP rights to prevent the infringement of pharmaceutical patents.
  • Clinical Trials: We provide legal support in obtaining necessary approvals for clinical trials, ensuring compliance with both Indian laws and international ethical standards.

International Perspective:

Pharmaceutical companies often operate globally, requiring compliance with international standards:

  • Regulatory Compliance: We assist clients in navigating FDA (Food and Drug Administration) regulations in the US, and EMA (European Medicines Agency) approvals in Europe, ensuring that products meet global safety and efficacy standards.
  • Cross-border Collaborations: We advise on international licensing agreements and strategic partnerships in the life sciences sector, ensuring compliance with local and international laws.