Regulatory Support

Our experienced professionals have thorough knowledge and understanding of the regional specific requirements and legal obligations. We carefully assess your needs and integrate our expertise to provide viable strategies that will maximize product’s success. We carefully evaluate our customer’s need and customize our services.

We provide Local Agent Representation services including:

  • Key interface between the company and the regulatory authorities.
  • Key interface between the company and the local market.
  • Arrangements for company to import, export or manufacture pharmaceutical medicines and medical devices.
  • Manage the legal responsibilities in regulated markets for company.

With exceptional knowledge of current regulatory guidelines and experience in Global Regulatory Affairs, our experts provide regulatory advice and establish a strong regulatory strategy including:

  • Strategic regulatory framework from product development to approval and throughout the life cycle management
  • Advise on procedures and formats
  • Subsequent negotiations necessary to obtain and maintain marketing authorization for the pharmaceutical products
  • Advise on the regulations and scientific requirements to help in development strategy from a regulatory perspective and assess the acceptability of quality, pre-clinical and clinical documentation for submission filing
  • Technical advice and scientific justification
  • Regulatory compliance with regional and local requirements

We have experienced regulatory professionals with extensive industry experience across diverse Regulatory Affairs to advice clients to leverage their existing regulatory approvals to enter new markets rapidly and cost effectively including:

  • Gap analysis and review of existing approved dossier appropriateness for registration to new markets and to ensure that the submissions comply with regional and local requirements.
  • Gap analysis for the new dossier and anticipated queries from the agency.
  • Review of administration information and Product Information for the specific country.