Case Study 39: Regulatory Support for eCTD Publishing for Biologics

Company Situation

The Client is a US based biotechnology company with transfusion dependent products for Thalassemia. The client already has approved products in Europe and US and were looking for support with their eCTD submissions.

GRP Solution

GRP has significant experience in handling rare drug products in global markets including America and Europe. GRP has inhouse publishing and submission experts with experience in managing end to end publishing process along with maintenance submission. GRP has been acting as a multi-year partners to them with accurate planning of each steps considering the timelines with well-defined KPIs and KRAs. GRP implemented a phase wise approach for the publishing activities.

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China's NMPA

In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).