Regulatory

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Dossiers (CTD) compilation for submissions in:
- Asia
- Africa
- Middle East
- Central America
- South America
- North America
Dossier compilation in Common Technical Dossier (CTD) format and Conversion to eCTD for: - US FDA

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AFRA Pharma Consultant

Hillmist Harmony, Pune, Maharashtra
3.7/5
★★★★★
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(3)
GST- 27AJAPA5261E1ZR
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Product Description

Dossiers (CTD) compilation for submissions in:

  • Asia
  • Africa
  • Middle East
  • Central America
  • South America
  • North America

Dossier compilation in Common Technical Dossier (CTD) format and Conversion to eCTD for:

  • US FDA
  • Saudi FDA
  • European counties

DMF (Drug Master File):
We have associated with NABL Certified well established labs to carry out analytical testing.

We also perform the following studies, in co-operations to DMF preparation:

  • Structural Elucidation Studies
  • Analytical Report (COA)
  • Analytical Method Validation
  • Process Validation
  • Stability data studies
  • Determination & Validation of Potential Impurities & Solvent Impurities

(All the data supported by necessary Chromatograms & Spectrums)


PREPARE SUMMARY OF PRODUCT (SPC), PACK INSERT, PRODUCT RATIONALE.

Expert Reports

  • Quality
  • Pre-clinical
  • Clinical

Nonclinical Study Reports (Module 4)
Clinical Study Reports (Module 5)
Dossier conversion (from one country to another) and

Registration Assistance:

  • Worldwide Regulatory Consultation of Human medicines
  • Worldwide Regulatory Consultation of Veterinary medicines
  • Worldwide Regulatory Consultation of Medical Devices
  • Worldwide Regulatory Consultation of Food
  • Worldwide Regulatory Consultation of Dietary Supplements
  • Worldwide Regulatory Consultation of Herbal Drugs

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Regulatory

About the Company

Year of Establishment2011
Legal Status of FirmIndividual - Proprietor
Nature of BusinessService Provider
Number of Employees11 to 25 People
Annual TurnoverUpto Rs. 50 Lakh
IndiaMART Member SinceJun 2012
GST27AJAPA5261E1ZR

Afra Pharma Consultant (APC) is a private limited company based in Pune, India, established in the year 2011, and is the leading provider of quality resource for the regulation of pharmaceutical products including those deemed as consumer Health and OTC. APC dedicated team is comprised of consultants with rich experience of over 8-10 years in all aspects and at all levels of regulatory affairs in worldwide markets. The services are designed to meet all of the latest regulations, helping clients to meet all of the stringent requirements of the pharmaceutical world.

The company is managed by Mir Sadat Ali, who has been involved in the Regulatory Affairs industry for over 9 years in Saudi Arabia and has been there in all transit phases of regulatory changes from Ministry of Health to Saudi Food and Drug Authority to G.C.C. He has also successfully completed and worked on the projects like joint venture, technology transfer and finished products company registrations in the Middle East.
Afra Pharma Consultants has a satisfied network of clients, situated throughout the Europe, Asian countries, North Africa, GCC, Saudi Arabia and India. The company provides a comprehensive range of services, including Training, PIL, Project Management, Audits and Inspections, and Strategic Planning. Tailored to the individual client’s requirements, the services are designed for Pharmaceutical Companies of all sizes.

Afra Pharma Consultant strives to develop long-term relationships with clients, based on the highest levels of integrity, professionalism and trust. We are committed to doing business in an ethical and socially responsible manner.

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Seller Contact Details

Sadat Ali

H/201, Hillmist Harmony, NIBM Road
Hillmist Harmony
Pune - 411048, Maharashtra, India

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