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About Regulatory Affairs (RA)

Regulatory Affairs (RA) professionals play critical roles in a pharmaceutical industry because it is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.

The role of regulatory affairs is to develop and execute a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is approvable by global regulators but is also differentiated from the competition in some way and also is to ensure that the company’s activities, from non-clinical research through to advertising and promotion, are conducted in accordance with the regulations and guidelines established by regulatory authorities.

Our consultants act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.

We offer regulatory services in Pharmaceutical drug regulatory affairs, Regulatory affairs in product management, Regulatory affairs in clinical trials and Regulatory affairs in R&D

Below are various kinds of Regulatory Affair services we offer to our clients

  • Development, preparation, assembly and submission of complete Common Technical Documentation (CTD) for marketing authorization applications (MAAs) in both Europe and the USA.
  • Drug master file (DMF) compilation in Common technical documentation (CTD) Format including Open, Close, Review and submission of DMF writing.
  • Preparation and submission (US, Canada and Europe).
  • Dossiers compilation in Common technical documentation (CTD) Format including Administrative Information, CTD Overview, Drug & Product Part /CMC, Non Clinical and Clinical.
  • Conversion of paper or NEES documents into electronic dossiers using e-CTD (electronic Common Technical Document) software.
  • Preparation of responses to regulatory authorities, comment letters, and assessment reports.
  • Orphan drug designation/applications
  • We provide regulatory services mainly in DMF, IND, Manufacturing, Import & Exports, CMC, NDA and ANDA.
  • We also involve in preparation of case report forms, Product information (SPC and PILS).

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We excel in our industry so that you can get in yours

  • Get in Touch

  • Address:
    Sathram Corp 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536
  • Email:
    hr@sathramcorp.com
  • Phone:
    732-380-5181
  • Office Hours:
    Monday - Friday : 9.00AM - 5.00PM