PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers.
Our core services support each stage of the product lifecycle, including drug development, clinical trial supply, commercial launch and ongoing commercial supply. We partner with clients in providing innovative technologies, flexible solutions, and an integrated supply network supporting lifesaving medicines destined to over 100 countries around the world.
State-of-the-art cGMP facilities in North America, Europe and Australia support products destined to over 100 countries; site segregation for Sch II-V Controlled Substances, Animal Health, Hormonal Products, Penicillin Products, Cytotoxins, SafeBridge™ Band 1-4 Potent Compounds; Cold Chain packaging and distribution at 2-8°C, -20°C, -40°C, -80°C, and -196°C for Advanced Therapeutic Medicinal Products (ATMPs); low humidity packaging; and modified environments for oxygen and light sensitive products.
Full service Formulation Development including Analytical Development/Characterization. We are able to offer formulation development services for a variety of dosage forms including: tablets, capsules, powders, gels, creams, liquids, solutions, suspensions, emulsions, suppositories, pessaries, granules for reconstitution, and drug in capsule/vial.
CLINICAL TRIAL SERVICES:
Tablet, Capsule, Powder and Liquids Manufacturing, Analytical Development, Stability Testing, Clinical Packaging & Labeling including product Blinding & Randomization, Global Storage & Distribution, sterile & non-sterile drug manufacture for early stage studies, as well as Returns Management & Destruction.
Commercial drug manufacturing including Commercial scale-up. Packaging Services for Oral Solids, Powders, Liquids, Creams, and Gels, as well as Injectable & Parenteral Delivery forms including Device Assembly. Analytical & Stability Services in support of commercial supply.
Contained manufacturing and packaging services for clinical and commercial medicines. PCI’s state-of-the-art, purpose-built, contained manufacturing site handles potent compounds with OEL’s down to 0.01μg/m3, and was recognized by ISPE as a Facility of the Year in 2013. Contained potent compound manufacturing is further supported by segregated, purpose-built packaging facilities in both Europe and North America.
Leveraging over 7 years of commercial Serialization services to domestic and emerging markets, PCI offers clients both integrated and stand-alone Serialization solutions.
In the last year, PCI acquired Millmount Healthcare, located in Dublin Ireland in the European Union, Pharmaceutical Packaging Professionals located in Melbourne, Australia, and Sherpa Packaging Professionals located in San Diego, CA.
Posted Date: 10/31/2018
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