cGMP Lab & CMC Services

PPD is a leading provider of chemistry, manufacturing and controls (CMC) laboratory services for all phases of drug development and follows current Good Manufacturing Practices (cGMPs).

Full range of analytical services in state-of-the-art cGMP facilities

With more than 200,000 square feet of space and cutting-edge cGMP facilities and equipment in Athlone, Ireland; Middleton, Wis.; and Wayne, Pa., we provide fully integrated product and analytical development services. Our CMC services range from early characterization, formulation and method development through commercial release and stability. Our highly qualified cGMP lab staff works with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices. PPD’s cGMP laboratories house one of the premier inhalation product analysis facilities in the industry at the Middleton, Wis., site.

• Our Wayne, Pa., facility includes testing for vaccines and biologics
• The Athlone facility also provides regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms

PPD offers a full range of CMC laboratory testing services for a broad range of products and dosage forms, including:

• Biopharmaceuticals testing
• Compendial testing
• Customized, electronic and cumulative reporting
• Extractables/leachables analysis
• Inhalation product testing
• Method development and validation
• Microbiology
• Product and materials characterization
• Protocol development and consultation
• Quality control and release testing
• Stability and photostability testing, storage and management

For more information about PPD’s CMC laboratory services, take our cGMP laboratory online tour.