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Regultory Affairs – In the ever-changing pharmaceutical regulatory environment, it is important for pharmaceutical companies to keep their knowledge abreast of international legislations, guidelines and customer practices in all countries.

Regulatory Affairs

Regulatory Affairs at 4C is a team of competent professionals that brings on average over 20 years of 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 globe
  • 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
  • Regulatory classification of products across different jurisdictions
  • Conduct face-to-face Meetings with Regulatory Authorities
  • Provide expert regulatory CMC compliance advice throughout development
Regulatory Affairs Strategy

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, 4C can help you with efficient gap analysis and ensuring the timelines for submission.

Regulatory Affairs Dossier Writing

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

4C operates in partnering with globally recognized submission software tool provider EXTEDO to enable solutions covering the entire regulatory landscape.

Regulatory Compilation and Publishing:
  • Dossier Preparations and Gap Analysis
  • Product Registration support: NDAs, ANDAs, MAA and other global registration applications
  • PMA, 510K, CE, IFUs, IDEs, CERs and CEPs for Medical Devices
  • BLA Support for Biologicals
  • Conversion of Dossiers (Paper / NeeS / eCTD)
  • Life Cycle Management
  • License, Maintenance and Renewals
  • Structured Product Labeling (SPL)
  • Regulatory Software Support Services
  • Compliance and Validation Services
  • Regulatory Information Management
Regulatory Affairs Compilation

We at 4C are equally committed in terms of quality service and support for large organization and regulated small businesses. We understand the challenges of small and medium enterprises and support them comply with regulations through custom services.

Regulatory Affairs
Establishment registrations and US Agent support Services:
  • Establishment registrations
  • US Agent support services
  • Web Trader registrations
  • Regulatory Software Support Services
  • Drug Listing services
  • Regulatory Information Management

4C is a comprehensive healthcare solutions provider company, specializing in Pharmacovigilance, Medical Information Call Center, Regulatory Affairs, Medical Writing, Clinical Data Management and Hosting Solutions

15 Corporate Place South
Suite 110
Piscataway, New Jersey 08854

Phone: +1 (732) 529-6989
Fax: +1 (732) 529-6990