FERRERE has extensive experience in the Pharmaceuticals and Biotechnology industry, particularly in detecting regulatory opportunities and threats for its clients. Its accrued knowledge and experience facilitate regular coordination with pharmaceutical chemists and specialists in regulatory areas, to keep its practice in step with the sector’s technological progress.

Thanks to the emphasis on specialization that characterizes the pharmaceutical industry team, clients use its services in strategic activities.

Especialidades dentro del área:

  • Company authorizations, GMP registration, product transfer procedures, and regularization with health authorities and regulators
  • Advice on obtaining complex product registries, filing or changes in representation and/or licenses
  • Handling of delicate situations related to product recalls
  • Advice on incorporation of new technologies (medical and high-cost products) with drug therapeutic formularium
  • Advice on implementation of patient-support programs
  • Advice on regulatory matters: distribution agreements, contract negotiation and termination.  Impacts due to change in distributor and registry transfer
  • Advice on regulatory matters of quality control agreements, logistics and outsourced services in general, as well as processing of applicable authorizations
  • Advice on public tenders; preparation, assignment of awardee capacity
  • Advice on implementation of mergers and demergers, product transfers and regularization with regulatory authorities
  • Advice on donations
  • In-house courses on regulatory updates