Chemistry and Manufacturing Controls Regulatory Affairs

We specialise in providing consulting and contracting services in Global CMC regulatory affairs.

Orchard CMC understands the importance of quality timely submissions for licence approval and variation.   We will work with you to get your products on the market as early as possible and support your maintenance activities in an efficient manner.

We have experience across a wide range of dose forms with particular expertise in drug substance.

Our services in quality matters range from pre-approval clinical trials stages to MAA/NDA preparation and beyond to post-marketing activities.

We can carry out or assist with

• CTD content authoring and dossier preparation

• Modules 2 and 3
• IND, IMPD
• NDA, MAA
• DMF, CEP
• Variations and supplements

• Responses to questions
• CMC gap analysis

Click on the links to the left for further details.