Regulatory Affairs Services

Global strategy.Local compliance. Submission-ready execution.

EMA (EU)
  • Centralized, DCP, MRP, NP submissions
  • Scientific advice briefing books
  • eCTD dossier preparation (Modules 1–5)
  • Lifecycle management (variations, renewals, notifications)
  • National procedure & reliance routes
  • eCTD dossier compilation & submission
  • Pre-submission & accelerated review support
  • Lifecycle activities (variations, PSURs, renewals)
  • Pathway assessment: 505(b)(1), 505(b)(2), ANDA
  • Pre-IND & pre-NDA meeting support
  • IND, DMF, ANDA, NDA dossier preparation
  • ESG/eCTD publishing & SPL creation
  • Responses to IR, DRL, CRL
  • Labelling & SPL compliance
  • EMA centralized vs. DCP/MRP guidance
  • UK reliance route submissions
  • 505(b)(2) strategy planning (US)
  • UK Legal Representative / EU affiliate coordination
  • Regulatory CMC gap analysis
  • CTD Module 2 & 3 authoring
  • API/DP comparability assessments
  • DMF/ASMF/CEP preparation
  • Impurity profiling & reference standards
  • API stability programs
  • Post-approval variations & supplements
  • Comparability protocols
  • Renewals & ongoing compliance
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