The Center for Pharmaceutical Integration (CPI) provides Chemistry & Manufacturing Control (CMC) consultancy across the spectrum of drug development from early stages to commercialisation. The company was established in 2011 by Mick Banks and Mike Yelvigi who had previously held Vice President and Senior Director positions in Pfizer R and D. CPI has a multi-disciplinary team of over 20 highly experienced Ph.D. level, senior scientific & technical professionals with backgrounds in pharmaceutical & biotechnology areas. Collectively, CPI possesses over 500 years of CMC experience and expertise.

Customized CMC pharmaceutical consultancy services to meet your unique needs and budgets. Our services include

• Early Development (preclinical to Phase 1)
• Development of project strategy and provision of technical support.
• Assembly of submissions (e.g CTD for IND's) and interactions with Regulatory Agencies (including FDA/EMA).
• Development (Phase 2 & 3 to commercialisation)
• API synthesis and formulation development to commercialisation.
• Trouble shooting.
• Regulatory filings (Global).
• Quality & Technical Audits
• Due Diligence.
• GMP, GLP & readiness for Pre-approval Inspections (PAI).
• Merger and Acquisition Support
• Technical Integration of CMC units in R&D and manufacturing.
• Technology Transfer of API and Dosage Forms.
• Technical Training
• Drug Development.

Our clients include start-up, virtual/small companies, large companies, academic institutions and investment institutions. Let us help resolve your project and business challenges.

• Scientific rigor & technical scrutiny.
• Responsiveness and nimbleness.
• Openness.
• Value.
• Delivery (to milestones and agreed budgets).