Freyr Solutions and Services
Freyr supported for preparation of CTD and BLA Submission. Product registration in LATAM and APAC countries was done as per the Regulatory strategy developed by Freyr and agreed upon by the Client where Freyr executed the following activities:
- Assessment of the CMC data provided by the client and prepared gap analysis for the generation of additional data as per the USFDA requirements.
- The dossier submission strategy was developed by preparing country specific dossier checklist for the smooth submission of dossiers in LATAM and APAC countries within stipulated timelines to avoid pre-submission assessment delays in LATAM and APAC countries.
Freyr successfully supported a Korea-based biotechnology manufacturer in the preparation and submission of their Biologics License Application (BLA). This included ensuring compliance with regulatory requirements for CTD and facilitating the strategic registration of the product in the LATAM and APAC markets.
- BLA was successfully submitted in the USA.
- Product Registration Dossiers were submitted in many targeted LATAM and APAC countries within stipulated timelines.
- The project was successfully executed within agreed timelines.
