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Early Phase Product Development Solutions

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With more than 30 years of experience working on thousands of compounds, Eurofins BioPharma Product Testing has a unique and unmatched understanding of the analytical, regulatory, pre-formulation, formulation, and manufacturing envelope that encompasses the drug development process.

As your strategic partner, we combine our industry-leading drug development expertise with our understanding of the variations in manufacturing and regulatory landscape to deliver highly efficient Chemistry, Manufacturing & Control (CMC) services that can speed early-stage drug development programs.  We also offer a seamless transition to the scope and scale of CMC services needed for registration and commercial stages of drug product development.

We can support your therapeutic assets and accelerate progress from discovery through phase II clinical trials with our expertise and broad range of services, including analytical method development and validation, API and drug product release and stability testing, pre-formulation, toxicology test article preparation and analysis, formulation development, drug product manufacture, clinical trial material kitting, labeling and logistics, project management, regulatory consulting and regulatory submissions.

Enlisting Eurofins BioPharma Product Testing to facilitate your development process ensures a high quality development pipeline, reduces costs to you and  expedites the outsourcing process allowing you to focus on your strategic objectives.

Why Choose Eurofins BioPharma Product Testing?

  • We deliver increased project quality with reduced time-to-delivery and development costs
  • We have a deep understanding of the early development  requirements (clinical and non-clinical) to set strategic direction for delivery of phase I and II clinical material
  • Tightly coupled product development, process development, QC, QA, and drug product manufacturing teams
  • We provide full CMC support for IND/IMPD, NDA, BLA, ANDA submissions
  • We can help you reduce costs as one point-of-contact drives each aspect of the project
  • We reduce the time-to-delivery by decreasing the number of managed resource interfaces

Project Management

Our PMP Certified Project Managers oversee development assets from pre-clinical through phase II of development, including:

  • Coordination of analytical data for support of API supply, drug product manufacture and release and stability of clinical supplies
  • Management of the API supplier and commercial drug product manufacturing organization
  • Management of methodologies and specifications to meet development, stability and clinical release needs.

Drug Product Formulation Development Services

We provide formulation development services for all API types (small molecule, peptide, protein, RNA, DNA) and a wide range of dosage form types, including:

  • Injectables (solutions, suspensions, emulsions, nano-emulsions)
  • Oral solutions, tablets and capsules
  • Topicals (creams, ointments, gels, lotions)

We also provide a wide range of product development support services, including:

  • Toxicology test article preparation and analysis
  • Analytical method development, qualification, and validation
  • Comparator testing
  • Compatibility testing (excipients, container/closure, manufacturing materials, etc.)
  • Solubility and stability screening
  • QC release and stability testing
  • USP <467> (all classes of residual solvents in current chapter)
  • Customized method development/validation

Manufacturing

We expedite availability of clinical trial materials by providing manufacturing services, including:

  • Technology transfer
  • Manufacturing process development and validation
  • “Atypical” active pharmaceutical ingredients
  • Clinical packaging
    • Labeling, re-labeling
    • Randomization
    • Kitting
    • Logistics (storage, distribution, returns)

Quality and Regulatory Consulting

We help you navigate the regulatory landscape by offering regulatory consulting, including:

  • Quality compliance reviews/audits to assess:
    • Manufacturing processes
    • Quality systems
    • Laboratory methods and SOPs
    • Laboratory data
    • CAPA/OOS investigations
  • Contract quality auditing
    • Internal quality system assessment and review
    • PAI readiness audits and/or preparatory assistance
    • CMO assessment and qualification
    • Raw material vendors
    • Component suppliers
  • Quality review of regulatory submission information (API and drug product CMC sections)
  • Compile and/or review regulatory submission information supporting INDs, IMPDs, ANDAs, BLAs, NDAs
    • CMC data/information as “ready for submission”

Transition to Registration and Commercial Stages of Drug Product Development

We offer the scope and scale of services required to support registration and commercial drug product activities and a straightforward  transition from early stage development to late stage development.  Examples of late-stage services offered include:

  • Project management
  • Regulatory consultation and submissions
  • Quality support and consultation
  • Extractables and leachables testing
  • Raw materials testing
  • Small-scale manufacturing