Regulatory Consulting & Strategy

Regulatory Agencies worldwide has started implementing inclusive Regulatory system to control the manufacturing and usage of medicinal products, being compliant with stringent requirements is becoming a challenging issue for product registrations and drug approvals. Therefore, there is need to have well-defined Regulatory strategies right from the product development to lifecycle management to addressing all submission requirements, and to comply with the mandatory requirements.

Our services in this area include

  • Strategic planning to take the products approved in one region to other Regulated markets (for example,┬áthe USA to Europe or vice versa)
  • Stability study planning for all possible presentations / container closure system
  • Identification of reference medicinal product as per the global commercialization plan and defining the Regulatory route map.
  • Switchover from paper format to electronic Common Technical Document (eCTD) submission

Other Services


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