Penn's Chemistry, Manufacturing and Controls (CMC) Consultancy Service covers both proactive and reactive situations and encompasses 4 key stages:

Strategy development
Following review of information resulting from an initial diagnostic review a detailed strategic CMC development plan is drawn up.

Taking on board the development plan and feedback from the client a detailed working plan is developed. An operational team is formed to drive all support work. If issues arise as work begins, this provides a forum for feedback and rectifying of on-going challenges.

Penn CMC key advantages and benefits

• Access at all times to Penn CMC expertise via telephone and e-mail
• Senior level management profile, ensuring hands-on executive involvement throughout
• Early discussion and diagnostic ensures early anticipation of regulatory issues and a streamlined planning process
• Early definition of direction avoids unnecessary and costly commitment of resources
• Seamless progression to Penn’s operations and network resources allows a rapid, practical solution

Lead Consultant

• Paul Thomas B.Sc, C.Chem, MRSC, Director of Pharmaceutical Services and QP

Support network

Senior Operational Managers and Project Management Teams in the following key CMC support areas.

• Formulation Development
• Analytical Development
• Clinical Trial manufacturing, packing and labelling, storage and distribution

Penn CMC benefits at a glance

• Flexible and proactive approach
• Well positioned to support your development process
• Impeccable regulatory inspection record
• Significantly geared to current regulatory needs
• Capable of delivering true added value