Our dedicated Global Regulatory Affairs CMC Team offers CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through forward-looking gap analyses and meticulous preparation of source documents. Our dedicated team can add tremendous value to your development program and speed time to market.
CMC dossier preparation and technical review(IND/CTA/NDA for USA, Europe and China)
Consultation to evaluate strategy, planning and feasibility by staying abreast with key CMC activities, suggestion of any regulatory contribution
Gap analysis to evaluate documentation needs for filing readiness
Ensure that quality of source documents are ready for regulatory submission
Support to fill any gaps through renowned WuXi STA CMC platform and WuXi AppTec R&D platform
Translation of written English documents to Chinese or vice versa (e.g.,CMC dossier, technical documents) to different filing purpose
A team of highly skilled CMC professional, with average of ~10 years of pharmaceutical industry experience
In-depth regulatory CMC knowledge, with defined processes of thorough technical and quality control review in-house prior to client review
Multi-lingual ability to help respond to regulatory agency questions
Program and project managers to seamlessly coordinate across entire WuXi STA platform
Do you have peptide drug candidates in development? Attend our webinar co-presented by Yen-Huei Lin, Ph.D. Exec. Director,
Biopharmaceutical Development and Manufacturing at Neuraly and William Fang, Head of Oligo/Peptide Business about how an integrated CMC partnership was critical in accelerating a novel peptide to phase 1 clinical trial.