International Growth Readies PCI for DSCSA and FMD Regulatory Deadlines

Three acquisitions in 12 months bolster PCI’s global position for speed-to-market in support of clients’ drug development and commercialization.

PCI Pharma Services continues to focus its strategic investment on supporting the biopharmaceutical industry with global access, with an enhanced international presence to ensure drug development, manufacturing, packaging and supply services for clients and their patients in more than 100 countries worldwide.

The company’s strategy comes as Brexit is pending for the UK and EU, with important regulatory deadlines approaching in the U.S. and E.U., as well as for emerging market countries, PCI stands ready to ensure service continuity following considerable growth and strategic expansion.

To help mitigate Brexit risk, PCI has strengthened its EU presence vis s series of site expansions and investments that include a purpose-built laboratory and an expanded footprint in Europe.

DSCSA, FMD, traceability and serialization

PCI’s strategic program of investment and expansion has continued across its global network throughout 2018. PCI’s proactive approach has ensured that the organization is ready and compliant in advance of key regulatory implementation dates—including the U.S. DSCSA in Nov. 2018, the E.U. FMD in Feb. 2019, and emerging market traceability deadlines.

PCI’s serialization and anticounterfeiting technology investment includes more than 80 lines installed and actively supporting commercial products destined for the U.S., E.U. and other emerging markets.  

Early-stage development investment

PCI also continues to invest in services to support client development and commercialization of new medicines, focusing on services and technologies that provide speed-to-market. This includes investment in early-stage development and services expediting early-phase clinical studies, expert formulation and drug development solutions, new capabilities for early-stage manufacturing development including sterile drug deliveries, as well as advanced packaging technologies to get developmental product into study quickly.

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