PRODUCT DEVELOPMENT AND ANALYSIS


Vitas has internal procedures for release of identification, impurity and assay data on samples covering the range from clinical trial to medicinal products offered for sale. We perform release on APIs and finished products. Our Quality Manager is approved as a Qualified Person by the Norwegian Medicinal Agency.

Contact us to find out how Vitas can contribute in releasing your medicinal product.

 

We deliver analytical services on:

  • Active Pharmaceutical Ingredients (API)
  • Raw materials
  • Excipients
  • Solid formulations  
  • Tablets (coated and uncoated)
  • Capsules (hard and soft gelatine capsules)
  • Liquid formulations (solutions, suspensions, injectables)
  • Semi-solid formulations (gels, creams, ointments, suppositories)
 
 
Our services include but are not limited to:
  • Analysis according to official monographs (PhEur, USP, AOCS)
  • Method development/implementation/optimization & validation
  • Stability studies
  • Cleaning method development and validation
  • Forced degradation studies
  • Impurity profiles
  • Structural Elucidation of Unknowns
  • Reference Standard Characterization
  • Solubility studies
  • Response factor studies
  • Extractable/Leachables
  • Residual solvent analysis
  • Batch control
  • Release analysis
  • Process support
  • Container closure integrity testing
  • Dissolution and disintegration
  • Technology Transfer to QA at Contract Manufacturing partner
  • QP – Qualified person service
  • Patent Infringement – Analytical support
  • FDA Dietary Supplements Consulting


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