
Regulatory Regulatory Affairs Service
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Product Specifications
| Submission Types | eCTD, NeeS |
| Markets Covered | Global |
| Service Level | Full |
| Regulatory Expertise | Pharma |
| Document Types | Various |
| Compliance Standards | ICH, FDA |
| Usage | Drug registration and regulatory compliance support globally, encompassing eCTD submissions, NeeS documents, and various other regulatory filings for diverse markets, to ensure compliance with ICH and FDA standards. |
| Features | Global reach, Efficent service, Compliance support, Reduced time, Expert guidance, Dossier creation, Registration aid |
Product Overview
Key Features
-Ectd Submissions (For Us, Eu, Ca, Ch, Jp, Gcc And S.Africa Markets)
-Non-Ectd Submissions (Nees)
-Paper Ctd Submissions
-Cta (Clinical Trial Application)
-Impd (Investigational Medicinal Product Dossier)
-Ecopy (Publishing Of Pma, 510(K) And Ide)
-Vnees (Veterinary Nees)
Pharma Regulatory Services For Emerging Markets
- Asean Ctd (Actd) Dossier & Registration Services
- Asia Ctd/Country-Specific Dossier & Registration Services
- African Ctd/Country-Specific Dossier & Registration Services
- Gcc/Middle East Ctd/Country-Specific Dossier & Registration Services
- Cis - Ctd/Country-Specific Dossier & Registration Services
- Latam - Ctd/Country-Specific Dossier & Registration Services
Other Regulatory Services
- Cdsco/Dcgi/Fda/Dgft/Fssai/Ayush Liaison Services
- Import License / Registration Certificate Services
- Ba/Be Study Reports/Dmf/Method Validation / Process Validation Services
- Embassy Attestation/Legalization/Apostille Services
- Medical Writing / Translation Services
- Mfg./Test/Wholesale/Who-Gmp/Copp Certificate/License Applications
- Artworks Development And Compliance Services
Company Details
Focusing on a customer-centric approach, Prelude Regulatory Services has a pan-India presence and caters to a huge consumer base throughout the country. Get Others from Prelude Regulatory Services at Trade India quality-assured services.
Business Type
Service Provider
Establishment
2014
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Seller Details
Ahmedabad, Gujarat
Head - Regulatory Affairs
Mr. Kalpesh Khodifad
Address
Plot No A-915, Siddhi Vinayak Towers, Behind Adani CNG Pump, Makarba, Ahmedabad, Gujarat, 380051, India
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