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Regulatory services
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.