Registered in England and Wales No. 7817798 | Registered Office: 34 Spring Lane, Watlington, Oxon, UK , OX49 5QN
NDA/MAA Applications
info@orchardcmcconsulting.com +44 (0) 1491 612198
We specialise in the following areas of CTD dossiers or equivalent for other regional formats such as ASEAN and iCTD
- Module 2.3 Quality Overall Summary (QOS)
- Module 3.2.S Drug Substance
- Module 3.2.P Drug Product
- Module 1 CMC documentation for EU e.g. application form annexes
- Responses to questions
- Gap analysis of Module 3 for submission in new markets
