Regulatory Affairs

Regulatory Affairs

Regulatory Affairs at IR is a team of competent professionals that brings on average over 20 years of a good experience in multinational pharmaceutical corporations who can help you with regulatory support of: new chemical entity development, clinical trials, marketed products, generics, OTC products, medical devices, biologics & nutraceuticals.

REGULATORY STRATEGY AND CONSULTATION:

  • Advice on Regulatory strategies for successful product market entries across the Pakistan
  • Guidance for regulatory pathway that is necessary for timely regulatory approval
  • Advice on industry trends and current market needs
  • Advice on Regulatory Affairs and Regulatory Operations Outsourcing
  • Advice on the Regulatory mergers and acquisitions

MANAGING A MULTI-COUNTRY

Managing a multi-country dossier and maintaining consistency across disciplines and documents could be cumbersome and sometimes causes delay in completing regulatory submissions.

With a cross functional experience in regulatory affairs, medical writing and pharmacovigilance, IR can help you with efficient gap analysis and ensuring the timelines for submission.

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REGULATORY WRITING:

  • Preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for drug substances and finished formulations
  • Preparation and Submission of Annual Reports, Variation Applications, Renewal Application, Amendments and Supplements
  • Preparation and Submission of Health Authority query responses
  • Preparation of Clinical and Non-clinical Module documents
  • Quality Overall Summaries (QOS)
  • Integrated drug development reports
  • TMF, DMF, ASMF, Applications and Submissions

REGULATORY AUTHORITIES EXPECT

Regulatory Authorities expect pharmaceutical companies to implement meaningful and effective strategies to manage their data integrity issues based upon process understanding and knowledge management of technologies.

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REGULATORY COMPILATION AND PUBLISHING:

  • Dossier Preparations and Gap Analysis
  • Compliance and Validation Services
  • Regulatory Information Management
  • Regulatory Affairs Compilation

We at IR are equally committed in terms of quality service and support for large and small organization. We understand the challenges of small and medium enterprises and support them comply with regulations through custom services.

WANT TO WORK WITH US

We are always looking for new challenges and interesting parterns. Also, we love to say hello.