CMC pharmaceutical consulting & supply chain services

Whether you’re developing an oral small molecule, an autologous cell therapy, or anything in between, our CMC pharma experts can support your pipeline in the US and Europe. Each of our consultants brings significant industry experience and specialized knowledge across a range of therapeutic modalities, disease areas, and geographies. This allows us to build projects teams that match the precise CMC needs of each client.

Sound CMC strategy and execution frequently results in time and financial resource savings by heading off possible challenges early in product development. Additionally, our CMC experts often work in an integrated fashion with other disciplines on broader consulting projects, helping to ensure an aligned path forward for our clients.

Our CMC capabilities:

Pharmaceutical development strategy

Cytopharma provides technical and regulatory strategic planning support through the various stages of a product’s pharmaceutical development, applying “quality by design” principles and helping clients get the most from their CMO/CDMO/CPO relationships. Our experts can help ensure the manufacturing process is optimized and development moves efficiently forward towards regulatory submission with a product of consistent quality and performance.

CMC regulatory support

Our CMC consultants are experts in the FDA/EMA regulations that pertain to CMC, including the additional complexities biologics and cell and gene therapies present, such as with manufacturing process optimization. Our team can provide high-level reviews to help uncover any potential regulatory issues, review and/or prepare regulatory submission packages, and assist with interactions with regulatory bodies, in the US, Europe, and other territories.

Within our network are CMC professionals with advanced expertise in many therapeutic areas and disease indications, allowing us to provide experts with the exact regulatory experience our clients seek. This has proven to be critical, especially with engagements involving autologous products, which may change meaningfully from the time their IND is first granted.

Quality management systems and cGXP compliance/audits

Cytopharma QA experts can help you develop an effective quality management system and prepare your facilities for cGMP inspection, both with the FDA and EMA. We also conduct compliance audits of manufacturing facilities and have consultants available for in-person plant visits.

CMC due diligence

Cytopharma frequently provides CMC due diligence to support business development activities, including technical review of CMC-related program documentation, to ensure that prospective licensees and investors are aware of any issues that may affect a transaction. If an issue is uncovered during a DD exercise, we typically provide risk mitigation strategies.

Upstream & downstream supply chain consulting

As a component of commercial launch planning activities, Cytopharma consultants help our clients get their product to customers in key geographic markets, by providing expertise in strategic and tactical design, as well as the legal, financial and practical setup, of pharmaceutical supply chains. Our experts will help you build a patient-oriented supply chain that balances the needs of the patient, the providers, the market and the company, in compliance of local regulations.