Quality First, Every Time

Regulatory Affairs

At CLB, we have a professional regulatory affairs team with filing and submission experience in China, USA and EU. CLB provides professional regulatory consultant services as well as dossier preparation services.

Regulatory Dossier Support
  • Dossier prep for IND/BLA/NDA/DMF
  • Strategize meetings with regulatory authorities on documents preparation and technical advice
  • Support queries and responses from regulatory authorities
  • Pre and Post approval support, dossier updates, variation submissions
Regulatory Advisory
  • Regulatory strategy and gap analysis for China, USA, EU and emerging markets
  • Professional recommendations on an efficient regulatory pathway
  • Continuous support on drug lifecycle management
  • Support inspection and audits of regulatory authorities and clients
Regulatory Intelligence
  • Keeping clients informed by staying abreast of regulatory updates
  • Monitor the latest industry trends globally and in China
  • Provide the product development strategy according to the regulatory trends
  • Provide support on commercial manufacturing as per regulatory changes