Regulatory Support

We provide comprehensive support for global regulatory application, validating the reliability of your supply and our consistent high quality

We support you with well-versed regulatory service, including consulting/strategic services, scientific advisory meetings, preparing regulatory dossiers and supporting for agency communication/responses preparation.

We have the capabilities and experience of IND/CTA and BLA/MAA/NDA dossier preparation (English, Chinese) and application worldwide with proven success. Our regulatory team has established a close working relationship with regulatory agencies in US, EU, Australia, China and other Asian countries, and has comprehensive understanding and knowledge of competent authorities’ laws and regulations to provide strategic regulatory advices throughout the product development lifecycle.

As a strategic cooperation organisation, Scendea and Chime Biologics can jointly provide a more comprehensive regulatory service.

Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. Scendea’s origin dates back over 20 years, with involvement in over 1,000 development programmes. Scendea has team members based in the UK, Ireland, the Netherlands and the US. Scendea’s expert team deliver strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory to successfully guide products from early development to marketing approval. A combination of scientific excellence, industry experience and commercial awareness allow our expert team to solve complex issues associated with medicinal product development, aligned to jurisdiction-specific regulatory requirements.