Regulatory Support

REGULATORY SUPPORT

MEDYUR provides regulatory supports for registration and marketing of pharmaceutical and nutraceutical products in foreign countries.

We provide all the required documents for registration of pharmaceutical products along with the working standards and samples.

All the legal documents related to manufacturing plant is duly notarised as per the need of the registering country.

We have a dynamic team who is proficient in various languages for communication and translation of documents.

  • We provide CTD and ACTD Dossiers for all products.
  • We provide Certificate of Pharmaceutical Products (COPP).
  • We provide Certificate of Analysis (COA).
  • We provide Free Sale Certificate (FSC) certificate.
  • We also provide Bioequivalence (BE) study for selected products.

CTD DOSSIER:

CTD Dossier is the Common Technical Document used for registration of pharmaceutical products. It is mostly used in regulated countries like United States, Europe, Canada, Japan etc.
It is submitted to the regulatory authorities/Food and Drug Authorities of country registering the product along with all the legal documents of manufacturing plant.

It consists of 5 modules:

  • Module 1 – Administrative Information which is specific to the countries
  • Module 2 – Common Technical Summary and Overview
  • Module 3 – Quality of the product
  • Module 4 – Non-Clinical Studies Report
  • Module 5 – Clinical Studies Report

ACTD DOSSIER:

ACTD Dossier is the Asean Common Technical Document used for registration of pharmaceutical products. It is mostly used in ASEAN (Association of South Eastern Asian Nations) region like Vietnam, Singapore .
It is submitted to the regulatory authorities/Food and Drug Authorities of country registering the product along with all the legal documents of manufacturing plant.

It consists of 4 modules of the CTD Dossier:

  • Module 1 – Administrative Information which is specific to the countries
  • Module 2 – Quality of the product
  • Module 3 – Non-Clinical Studies Report
  • Module 4 – Clinical Studies Report

CERTIFICATE OF PHARMACEUTICAL PRODUCT
The certificate of pharmaceutical product (CPP or COPP) is a certificate issued in the format recommended by the World Health Organization (WHO).
The COPP will be issued by zonal/sub zonal officers on behalf of Drugs Controller General of India after inspection and satisfactory clearances by CDSCO officers as per WHO – GMP guidelines.
It is valid for 3 years from date of issue and companies can apply for renewal at the time of expiration.
A COPP demonstrates that the registered medicine is of the appropriate standard of quality, safety and efficacy to allow marketing in their market, having undergone rigorous testing and examination to Regulatory Authorities in the exporting country and also demonstrates that it follows the correct guidelines and procedures of Good Manufacturing Practice (GMP), increasing the level of quality and indeed safety of the product.

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