Pharma Engineering Services provides consulting / contract services to pharmaceutical, biotech, life sciences and medical device industries with focus in program management and product development including combination product design control, cross-functional program management, and engineering support. Advise / support companies in CMC development including regulatory filings and PAI readiness. Pharma Engineering Services also provides CMO and CSP oversight including Person-In-Plant, Batch Release, and compliance support.Recent product developments include: prefilled syringes, intravitreal products, aerosolization devices, anesthesia, innovative delivery systems, solid oral dosage forms, and biosimilars.Recent clients include: The Medicines Company, Impax Laboratories, Coherus Biosciences, Triple Ring Technologies, Arcutis Biotherapeutics, Escape Bio. Supported FDA approvals: UDENYCA®(pegfilgrastim-cbqv injection), LEQVIO® (Inclisiran injection), SYROVRE® (pegcetacoplan injection)

Provided Project Management and Project Engineering services overseeing design and procurement of new USP Purified Water System. Technical advisor for implementation of new Global Engineering systems and policies to improve efficiencies across the global organization. Supported FDA 483 and Warning Letter remediation activities, which resulted in successful resolution letter from FDA in Sept. 2015.