Isha's GMP Consultancy Private Limited, Chennai - 600 014, India Mon-Sat 09:00 AM- 18:00 PM +91 8667589984
Isha’s GMP Consultancy

Contact us:

Isha’s GMP Consultancy,
D.No.6, Flat No.2B,
2 nd Floor,
Gankai Amman Kovil Street
Royapettah,Chennai-600014,India
Branch office
Under registration at Ireland ,
United Kingdom
Monday – Saturday 08:00-19:00
+91 8667589984,+91 8939666562

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      Regulatory Affairs

      It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and its extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions.

      We provide Technical Support in the below mentioned Areas:

      • Preparation of Drug Substance and Drug product registration dossier
      • Dossier Preparation & Submissions Support 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 labelling] 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