Facility Audit for Compliance
Strategic Services
- Strategic assistance in Pharma Regulatory filing
- Support in Outsourcing Manufacturing or Testing Laboratories for Clients
- Support in Outsourcing BA/BE study centers
- Liaison for DCGI licensing & FDA, CDSCO activities
Advisory Services
- cGMP (current Good Manufacturing Practice) compliance
- Advisory services to queries pertaining to pharma GMP, GLP, QA and regulatory affairs
- Compliance audits as per current and updated statutory pharma regulations
- Critical Review of Dossiers
- GAP Analysis/Due diligence
- Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms
Technical Assistance
- Preparation of Drug Substance and Drug product registration dossier
- Dossier Preparation & Submissions in CTD [(Electronic Common Technical Document (drug registration)]/eCTD, ACTD [Asian Common Technical Dossier]
- NeeS [Non-eCTD electronic Submissions (NeeS)] formats to different Health Authorities of Regulated and Semi-Regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, MCC-SA, ANVISA, ASEAN countries and ROW markets including Indian DCGI and CDSCO
- Drug Firm Establishment Registration with US-FDA [United States’ Food and Drug Administration] (FEI [Facility Establishment Identifier])
- Drug Listing in SPL [Structured Product labeling] format, Bulk Drug Listing
- NDC [National Drug Code] and Electronic submission
- Preparation of DMF [Drug Master Files]/ ASMF [Active Substance Master File] / CEP [Certificate of Suitability] or (CoS) / KDMF/ Technical Packages
- Site Master file as per PIC/s & Local FDA requirement