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Regulatory Affairs Services
Regulatory Affairs Services
Expert Guidance for Global Market Compliance
Defining a clear regulatory strategy is essential for successful product approvals across target markets and regions. This includes patent terms and extensions, application processes, data requirements, and launch deadlines.
Our Technical Support Covers:
Drug Substance & Product Registration Dossiers
- Preparation & Submission of Dossiers in various formats:
  • CTD / eCTD (Electronic Common Technical Document)
  • ACTD (Asian Common Technical Dossier)
  • NeeS (Non-eCTD Electronic Submissions)
   ✔ Submission to Health Authorities in Regulated & Semi-Regulated Markets, including:
  • US-FDA, Health Canada, EMA (Europe), UK-MHRA, MCC-SA, ANVISA, ASEAN Countries, ROW Markets, CDSCO & DCGI (India)
US-FDA Compliance & Drug Registration
- Drug Firm Establishment Registration (FEI – Facility Establishment Identifier)
- Drug Listing in SPL (Structured Product Labeling) Format
- Bulk Drug Listing & National Drug Code (NDC) Electronic Submission
Regulatory Filings & Documentation Support
- Drug Master Files (DMF) / Active Substance Master File (ASMF)
- Certificates of Suitability (CEP/CoS) & Korean DMF (KDMF)
- Technical Packages for Drug Submissions
- Site Master File (SMF) Preparation – Compliance with PIC/S & Local FDA Requirements
Why Choose Isha’s GMP?
- Comprehensive Regulatory Support – From dossier preparation to global submissions
- Expertise Across Global Markets – Ensuring compliance with diverse regulatory authorities
- Streamlined Documentation & Filing – Reducing approval time and regulatory risks
Need Regulatory Assistance?
Let Isha’s GMP help you navigate the complexities of regulatory compliance. Contact us today!