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Regulatory services

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  • Our qualified experts are competent to simplify the end-to-end product life cycle management with their multi-disciplinary experiences.
  • Regulatory Experts contributes in every step of process from product design to Life Cycle Management of simple to complex molecules.
  • Our experts are experienced for entire lifecycle of drug Product in all regulated markets.
  • Our Regulatory experts define strategical solutions for a successful regulatory approval and maintain life cycle management as a valued partner.
  • Proficient working relationship with global regulatory health authorities.
  • Ensure safe and streamline product introduction to patients and prescribers.
  • Access to national database and Regulatory Intelligence.
01

Pre-submission activities like Regulatory Due Diligence and Regulatory Strategy Design.

02

Submission of Marketing Authorization Applications throughout the globe including CP/DCP/MRP/NS for Europe.

03

Compilation of modules 1-5 in eCTD format.

04

eCTD compilation and Publishing.

05

Post-Marketing Authorization Maintenance including variations, renewals and notifications.