COONEY PHARMA CONSULTING, LLC 

With extensive expertise in the area of Drug Substance / Active Pharmaceutical Ingredients (API) development and manufacturing, Rita can help your company navigate the complicated world of APIs.    She has experience with both New Chemical Entities (NCEs) and generic APIs, and associated regulatory CMC and Drug Master File (DMF) filing requirements.

 

 

• API process development and analytical requirements associated, from key raw materials to in-process controls, isolated intermediates, and final drug substance

• Predominantly small molecule APIs, synthentically or naturally derived

• Second-source API qualifications for existing marketed commercial drug products

• Procurement of appropriate third-party CDMO for your required API

• Working with third-party suppliers of key raw materials, intermediates or final API

• Investigate problematic APIs in terms of release specification failures, new impurities, stability failures

• Considerable experience with cGMP API manufacturing processes

• CMC sections for IND, NDA, ANDA and DMF regulatory filings

• Post-approval (CBE0, CBE30, Prior Approval) justification for method and spec changes

• Cleaning requirements and residual limits for manufacturing equipment (rinses and swabs)