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Pharmaceutical Compliances:

India has emerged as one of the leading markets for pharmaceutical products. Increase in the private healthcare infrastructure, widening rural markets, and inclusion of newer technologies have placed healthcare as an independent sector in India. The Indian pharmaceutical industry is now discovering new opportunities of growth in clinical research, contract research, manufacturing and innovation opportunities. It has enormous growth potential due to various factors such as growing population, increase in the income, demand for quality healthcare service, changing lifestyle leading to change in disease patterns etc.

We, Singh & Associates represent varied clients like manufacturers/importers of drugs and medical devices, multinational pharmaceutical companies, distributors, etc. We represent a number of multinational pharmaceutical companies on turnkey basis.

The services provided by Singh & Associates in the field of Pharmaceutical and allied industries include:

  • Mergers & Acquisitions.
  • Advising and assisting clients on drugs regulatory compliances such as registration certificates, drug licenses, wholesale & retail licenses, labelling & packing compliances etc.
  • Addressing issues related to Drugs & Cosmetics Act, 1940 & Rules made therein, Drugs (Prices Control) Order, 1995, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 etc.
  • Appearance before regulatory bodies such as National Pharmaceutical Pricing Authority (NPPA), DCGI, various States FDAs, Drugs Inspectors etc.
  • Assisting MNCs in undertaking Clinical Trials in India.
  • Due diligence of pharma companies.
  • Drafting of various contracts/agreements.
  • Intellectual property related services.
  • Advisory services including without limitation to manufacturing, stock, sale, distribution compliances, good clinical practises and manufacturing practise requirements, regulatory strategies, price approvals, product liability, filing of review applications before the NPPA etc.

 



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