Regulatory Affairs

Regulatory Affairs

Services for Rare Diseases, Cell & Gene Therapies and Biosimilars.
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Pkinetix provides the following regulatory affairs services for rare diseases : orphan drug designations, pediatric rare disease designations, fast track designations, breakthrough therapy designations and humanitarian use exemptions. We also provide regulatory services for cell & gene therapies and biosimilars as well as standard product registrations, CTA submissions and meetings with Latin regulatory authorities in the following countries:

  • Argentina (ANMAT)
  • Bolivia (AGEMED)
  • Brazil (ANVISA)
  • Caribbean Countries (CARPHA)
  • Chile (ISPCH)
  • Colombia (INVIMA)
  • Costa Rica (ARN)
  • Dominican Republic (DIGEMAPS)
  • Ecuador (ARCSA)
  • El Salvador (DNM)
  • Guatemala (DRCPFA)
  • Honduras (ARSA)
  • Mexico (COFEPRIS)
  • Nicaragua (DGRS)
  • Panama (DNFD)
  • Paraguay (DNVS)
  • Peru (DIGEMID)
  • Uruguay (MSP)

Pkinetix offers a complete pharmaceutical regulatory affairs support service to assist you in the implementation of a global regulatory strategy for your products in Latin America (LatAm). The role of our staff is to tell you the current standards of the different national regulatory authorities in LatAm for your submissions, and what you need to do to meet them.

Our Regulatory services include:

  • Development, preparation, assembly and submission of complete Product Dossiers (PDs) in Common Technical Documentation (CTD) format (if necessary) for marketing authorization applications.
  • ​Preparation of responses to regulatory authorities, comment letters, and assessment reports.
  • ​Provision of support for scientific advice meetings, representation to regulatory agencies and/or meeting planning with national regulatory authorities.
  • ​Preparation and submission of clinical trial authorization (CTAs) and ethics committee applications.

Pkinetix regulatory affairs consultants have the experience to take a broad view of the pharmaceutical process. This means we are well-trained to tailor the submission of the sponsor’s documentation to facilitate a company’s chances of achieving product registration. Post submission, Pkinetix can assist the client in answering questions raised by regulatory agencies. Pkinetix will review all questions and examine submitted data and will work with agencies on your behalf to ensure an optimal path to market.