Lawyers

  • Manish Modak

    Partner

    BA. LL.B

    manishmodak@astrealegal.com

    Expertise IT, Retail,Due Diligence, Licence and Registration, Transaction, Asset Management, FDI, Risk, Assessment, Election Laws, Corruption and Bribery Laws, Adoption, Legal Strategy

  • Pradeep Rihal

    Sr. Associate

    B.Com. LL.B, LL.M.

    psrihal@astrealegal.com

    Expertise Legal Due Diligence, Work Permits, Credit, Risk Assesment, Security Fraud, Debt recovery, Defamation, Election Laws, Tribunals, Land Laws, Administrative Laws, Insurance, Work Permits, Extradition & Asylum, Forest laws, Corruption and Bribery Laws, Perjury.

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Pharmaceutical and Healthcare Industry

India’s pharmaceutical and healthcare sector is not only one of the fastest-growing but also among the largest contributors to revenue and employment in the country. With its dynamic advancements in technology, research, and global partnerships, the industry has witnessed a surge in the demand for robust legal and regulatory support.

At Astrea Legal, we understand the complexities and nuances of the pharmaceutical and healthcare industries.

Key Components

  1. Agreements and Contracts
    • Drafting and negotiating Distribution, Manufacturing, and Supply Agreements.
    • Legal support for Import and Sponsorship of Drugs.
  2. Product Liability Defense
    • Assistance in resolving disputes related to defective drugs or healthcare products.
  3. Licensing
    • Guidance on obtaining and maintaining licenses necessary for healthcare and pharmaceutical operations.
  4. Intellectual Property (IP) Protection
    • Assistance with Patent and Trademark registration.
    • Support with Know-How Licensing Agreements.
  5. Compliance and Regulations
    • Ensuring adherence to Labeling, Packaging, and FSSAI guidelines.
    • Support for compliance with emerging healthcare laws and regulatory frameworks.
  6. Advisory Services
    • Structuring businesses for Hospitals and Healthcare Institutions.
    • Providing strategic guidance on Taxation and Investment Regulations.
  7. Litigation and Due Diligence
    • Representing clients in disputes and litigation.
    • Assistance with Structuring Foreign Investments and obtaining necessary regulatory approvals.

Sector Highlights

  • Pharmaceutical Innovation: Post-2005 amendments aligning India with WTO’s TRIPS compliance have revolutionized research-based product development while presenting challenges for generic manufacturers.
  • Healthcare Growth: Projected to reach estimate 638  US$  billion, the sector includes hospitals, medical devices, clinical trials, outsourcing, and insurance.
  • Stem Cell Research: India is making strides in this field, with pending regulatory frameworks expected soon.

Astrea Legal is committed to offering customized and strategic legal solutions tailored to the evolving needs of the pharmaceutical and healthcare sectors.

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