Sharp Services


Sharp is a global leader in pharmaceutical packaging, clinical trial supply services, and small-scale sterile manufacturing, with a heritage spanning over 70 years. They partner with pharmaceutical and biotechnology clients, offering solutions from phase I trials to commercial launch and lifecycle management. Their team leverages state-of-the-art GMP facilities across the US, UK, Belgium, and the Netherlands, committed to quality, innovation, and customer success.

Industries

health-care
life-science

Nr. of Employees

Very Large (1000+)

Sharp Services

Sharp Services, LLC, [Address not specified in the content]


Products

Clinical Trial Supply Services

Support for pharmaceutical and biotechnology clients from Phase I trials to commercial launch, reducing risk, complexity, and trial length.

Commercial Pharmaceutical Packaging Services

Primary and secondary packaging solutions from GMP sites in the US, EU, and UK.

Sterile Fill-Finish

Manufacturing, packaging, and distribution solutions for sterile injectable products through a partnership with Berkshire Sterile Manufacturing.

Analytical Services

Comprehensive analytical testing including excipient/raw material release testing, in-process testing, QC release testing, stability testing, and impurity profiling.

Comparator Drug Supply

Global sourcing, procurement, and blinding of comparator products for clinical trials.

Primary Packaging

Isolator-based sterile fill-finish and primary packaging services for investigational medicinal products (IMP).


Services

Aseptic fill–finish for clinical and small-to-medium commercial sterile injectables, including isolator-based filling, lyophilization and terminal sterilization, delivered from GMP sites.

End-to-end clinical services including investigational product sourcing, analytical release testing, packaging, storage, depot network management, distribution and direct-to-patient solutions.

Primary and secondary pharmaceutical packaging services including high-speed bottle and blister lines, serialization and cold-chain packaging delivered from GMP facilities.

Implementation and managed delivery of interactive response technology and clinical inventory management systems to support patient randomization, supply allocation and trial supply visibility.

Selection, implementation and integration of Manufacturing Execution Systems and electronic batch record infrastructure to support production control, batch documentation and release workflows.

Partnership-based logistics and distribution capabilities to support international clinical trials, including regional depot operations, import/export handling and local market support.

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Expertise Areas

  • Clinical trial supply chain management
  • Sterile fill–finish manufacturing for injectables
  • Pharmaceutical primary and secondary packaging
  • Injectable device assembly and labeling
  • Show More (10)

Key Technologies

  • GMP sterile fill–finish processes
  • Isolator-based sterile filling
  • Lyophilization (freeze-drying) technology
  • Primary and secondary packaging machinery
  • Show More (6)

News & Updates

Sharp's new facility in Rhymney, developed since 2017 and approved by the UK’s MHRA in early 2019, is fully operational and offers an extended range of clinical services.

An article discussing the collaboration between Sharp and ClinsChain to support clinical trials in China, addressing challenges and solutions.

An article exploring the science behind filling viscous drug products, focusing on pumps, pressure, and process optimization.

An article explaining the importance of the UN Global Compact and Sharp's involvement.

An article discussing the challenges and solutions in designing secondary packaging for sterile injectables.

An article providing key questions to consider when preparing an IND application.

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