We KNOW. We DELIVER.

Velesco Pharmaceutical Services offers the full menu of services to provide the most accurate data in a rapid timeframe. Our goal is to develop a customized plan dedicated to your compound for a fast, cost-efficient and compliant path to clinical development.

 

 Analytical Method Development / Validation

  • Stability-indicating methods
  • Drug substance
  • Forced degradation
  • Chiral methods
  • Drug product (tablets, capsules, etc.)
  • Stability testing in support of first-in-human studies
  • Content uniformity method development, validation and testing
  • Dissolution method development, validation and testing
  • Blinded comparator agent testing
  • Method troubleshooting
  • Method optimization
  • Extractables/leachables
  • Impurities
  • Cleaning verification method development/validation
  • Technology transfer


 

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Preformulation

  • Excipient compatibility
  • Hygroscopicity determination
  • Polymorph identification
  • Crystal size and habit
  • pH solubility profile
  • cLogP determination
  • Bulk/tap density
  • Flowability
  • Compressibility

 

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Formulation

  • Toxicology
  • Hard and soft gelatin capsules
  • Creams
  • Ointments
  • Oral and topical liquids
  • Small and large volume parenterals

 

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Early Phase GMP Supplies

 

  • Powder in bottle
  • Powder in capsule
  • Simple blends in capsule
  • Non-sterile liquids and semi-solids
  • Overencapsulation
  • Hand filled soft gels
  • Packaging
  • Release

 

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 Consulting

 

  • Project management
  • Vendor selection and oversight
  • Clinical supply chain management
  • Due diligence
  • Patent litigation support
  • Drug product development
  • Analytical method development
  • Facility and equipment validation
  • Regulatory support
  • GMP documentation

 

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