SERVICE PORTFOLIO
Global regulatory strategy, dossier development, eCTD publishing, DMF/CEP submissions & lifecycle management across international markets.
Preclinical in vitro/in vivo studies, nitrosamine risk evaluation, E&L studies, OEL/OEB assessments & PDE/ADE calculations.
On-site & remote GMP audits, supplier qualification, CAPA planning, QMS reviews & remediation for regulatory compliance.
Labeling strategy, artwork QC, PIL/SmPC development, promotional review & global label change management systems.
510(k), PMA, CE/MDR filings, TD files, biocompatibility, risk management, IFU and post-market surveillance solutions.
PIF creation, safety assessment, ingredient compliance, claims validation & international cosmetic regulation support.
IB, CSR, protocols, RMP, PSUR/PBRER, DSUR, Module 2 summaries & evidence-based scientific literature reviews.
Safety variations, signal detection, labeling updates, PSUR/PBRER submissions & continuous post-market safety compliance.
Competitor filing assessments, global regulatory tracking, opportunity mapping & real-time intelligence dashboards.
SOPs, QMS manuals, validation protocols, stability studies & regulatory audit response documentation for global facilities.
RIMS implementation, IDMP/XEVMPD submissions, automated compliance tools & digital transformation of regulatory workflows.
Driving digital transformation with innovation, security, and scalable technology.