About Regulatory services

❖ Dossier compilation for Module 2 to 5.
❖ Dossier documents review and Due Diligence.
❖ Dossier Publishing.
❖ Medical writing for Clinical and Non-clinical overview along with Summary.

OUR USP

Audited well known CRO’s Globally
Monitored 350+ Bio studies within multiple therapeutic areas
More then 60 GCP Audits (Pre-qualification & Routine audits)
More then 50 GMP Audits (Qualification of supplier & Routine audits)
Serving to 20+ National & International customers (Generic and Specialty pharma companies)
 CDISC Projects 15+
IVIVR-IVIVC Analysis for 7+ molecules
USFDA Pre-inspection Audits with zero 483
Out Licensing Project with International sponsors
Review/Preparation of Module 4 & 5/Module 2.4 & 2.5

CRO Qualification Audits & study specific Audits

Audit is an important element to ensure process, system, instruments, personnel etc…in advance to
verify compliance with GCP and regulatory specific guidance.