COONEY PHARMA CONSULTING, LLC
"your peace of mind during stressful times"
PHARMACEUTICALS
Whether you need expertise with your drug substance/API or formulated drug products Cooney Pharma Consulting, LLC can help. Rita has extensive experience from development through commercial launch, and a thorough understanding of cGMP manufacturing requirements and facility operations. She is experienced with DEA regulations and the requirements for handling controlled drug substances and products.
With extensive experience in the field of drug substance / APIs, Rita can help you with a variety of areas related to the life cycle of a drug substance from development and pre-tox studies to commercial marketed applications.
Rita also has considerable experience with solid and liquid oral dosage drug products, and sterile injectable drug products for IND, NDA and ANDA regulatory applications.
Having directed Analytical Organizations within the CDMO marketplace, Rita's experience and technical expertise is extremely valuable to those already in the industry, or looking to partner with a CDMO or CRO.