Pharmaceutical IPR and Regulatory Affairs

Development of a new pharmaceutical product requires at least 15 years because of changes in the regulatory. Regulatory Affairs Department acts as the interface between the pharmaceutical company and the regulatory agencies across the world. Regulatory authorities act a vital role for approval of generics.

Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment.

North America and Europe contribute about 57.0% of global pharmaceutical sales. The global regulatory affairs outsourcing market size was valued at USD 4.53 billion in 2016 and is expected to grow at a CAGR of 11.9% over the forecast period.

 

  • Drug Safety
  • Best Industry Practices
  • Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals
  • Regulatory Strategies and developments for new drugs
  • Regulatory Requirements for Pharmaceuticals
  • Pharmacoeconomics & outcomes research
  • Biosimilars

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