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Regulatory Affairs

Our experienced Regulatory Affairs consulting team will provide support from set up through to program close out.

During set up, our Regulatory Affairs consulting team conducts a comprehensive country by country feasibility exercise. As part of the feasibility exercise, we assess whether a Named Patient or Cohort approach may be best, as well as advise on label text. This results in confirmation of the specific regulatory requirements and ensures compliance.

Our experienced Regulatory Affairs consulting team monitors all regulatory activity during the program and provides support by interpreting and providing guidance for issues related to pre-approval access regulation.

Well before the transition to commercial product in the countries, our experienced Regulatory Affairs consulting team will advise on the regulatory implications and play a role in the communications to sites, ensuring no interruption to patient therapy during this critical time.

During set up, our Regulatory Affairs consulting team conducts a comprehensive country by country feasibility exercise. As part of the feasibility exercise, we assess whether a Named Patient or Cohort approach may be best, as well as advise on label text. This results in confirmation of the specific regulatory requirements and ensures compliance.

Our experienced Regulatory Affairs consulting team monitors all regulatory activity during the program and provides support by interpreting and providing guidance for issues related to pre-approval access regulation.

Well before the transition to commercial product in the countries, our experienced Regulatory Affairs consulting team will advise on the regulatory implications and play a role in the communications to sites, ensuring no interruption to patient therapy during this critical time.