Packaging and labeling

Packaging and labeling
Product Description

Alcami provides custom packaging, labeling, and kitting for clinical trial materials destined for trials anywhere in the world. We also provide specialized expert support for randomization and blinding studies, including placebo, comparator, and crossover studies, as well as reconciliation drug accountability, serialization, and destruction services as needed.
With the ability to accommodate preclinical through commercial lifecycles, our inherent flexibility allows clients direct access to a simplified supply chain. Alcami offers stand-alone packaging through full development programs that can be integrated with manufacturing, stability storage, and analytical services. We have made significant investments to upgrade our packaging lines for full serialization and aggregation capability. Partnering with TraceLink® has enabled us to have serial number generation and commissioning as well as data transfer with our clients and trading partners.

Alcami

  • US
  • 2016
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
Specifications
  • Selling Points
    Experienced Technicians; Quality Service
  • Supplied from
    United States

Alcami

  • US
  • 2016
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company

More Products from Alcami (17)

  • Analytical development

    Product Analytical development

    Alcami offers a fully-integrated analytical method development, method validation, and testing solution with a full complement of advanced analytical and information technologies. From Alcami’s electronic laboratory notebook (ELN) data collection system to its integration with our formulation development, ...
  • Biopharmaceutical development

    Product Biopharmaceutical development

    From initial characterization of drug substance to commercial batch release, each phase of your drug product development requires analytical methods to qualify the product for safety, integrity, strength, purity, and quality.  With these critical attributes in mind, Alcami’s biologics analytical devel...
  • Formulation development

    Product Formulation development

    Alcami’s formulation development team proactively guides your development program every step of the way – from Compound to Clinic.  Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing high-performance dose forms to meet today’s consumer needs. We offer...
  • Integrated offerings

    Product Integrated offerings

    Alcami is a Us-based, contract development, testing, and manufacturing organization for pharma and biotech companies. Our goal is to support our clients in making their projects go from potential to reality day-after-day.
    Core Capabilities:Sterile-fill finish development and manufacturingO...
  • Manufacturing

    Product Manufacturing

    Alcami offers cGMP manufacturing services with operations ready to scale in tandem with your development and approval milestones. From preclincial through commercial supply, Alcami’s development and manufacturing sites are DEA certified to manage controlled substances, APIs, and other complex compounds. Al...
  • Microbiology

    Product Microbiology

    Microbiological testing is an important factor in ensuring your product’s safety, efficacy, and timely project completion. At Alcami, we combine decades of microbiological expertise, developed from serving the biotech, pharmaceutical, and medical device industries, to provide the most current and effective...
  • Parenteral manufacturing

    Product Parenteral manufacturing

    Dedicated to manufacturing parenteral dosage forms, Alcami’s Charleston, South Carolina site supports preclinical production through commercial launch and supply. This US- and EU-compliant and DEA-licensed sterile manufacturing facility is fully integrated with our Wilmington, North Carolina packaging and ...
  • Solid oral dose

    Product Solid oral dose

    Specialized to manufacture oral solid dosage (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. We differentiate ourselves by providing ample problem-solving solutions to your scientific needs.  

    Our cGMP manufact...
  • Stability

    Product Stability

    Study Types-In-use studies (broaching, reconstituted product stability, multi-use container stability)
    -Formulation development studies including stress studies
    -Photostability (Options I and II)
    -Comparator studies
    -Thermal cycling/freeze thaw
    -Shipping excursion studies
    -Long-term stabi...
  • Analytical Services

    Product Analytical Services

    Method development and phase appropriate validations to support clinical and commercial programsCompendial Testing
    Raw Material Testing
  • Contract Manufacturing

    Product Contract Manufacturing

    Development and optimization of suitable manufacturing processes to support clinical and commercial programs
  • Contract Packaging

    Product Contract Packaging

    Support stand along packaging activities or integrated with Alcami's manufacturing capabilities. Can support packaging for clinical kits including kit assembly and commercial packaging.

Alcami resources (3)