Eviva offer a broad based pharmaceutical consulting service encompassing all aspects and phases of pharmaceutical development, including formulation development of most drug delivery systems.

Formulation Development

These range from phase 1 pre-formulation activities to clinical trials manufacturing in support of Pharma IMPD’s (formerly CTX) through to troubleshooting secondary manufacturing problems and technology transfers and associated CMC regulatory affairs.  These are supplemented by analytical method development/analytical chemistry consultancy.

Dosage forms that Eviva Pharma have developed include:

  • injections aqueous, lyophilised, co-solvents and micellar systems
  • oral dose including hard and soft gelatine capsules and tablets
  • syrups and suspensions
  • respiratory products including nebuliser solutions and inhalers
  • topicals including gels, creams and ointments

Product developments include human Rx, OTC, veterinary and ‘nutraceuticals’.

Phase 0/1

  • Pre-formulation; help in designing pre-formulation studies to support the formulation
    • Advice on compound selection where physico-chemical parameters are likely to be rate limiting for development
    • Salt selection guidance
    • Assignment of potency, standardisation of reference
    • pH-solubility, pH-stability
    • Binary mix compatibility/excipient selection
    • Solvent solubility
    • Physical characterisation of Drug Substance
    • Assistance in setting Drug Substance specifications
  • Formulation
    • Pre-clinical dosage form design
    • Selection of most suitable dosage form to suit the clinical indication
    • Optimisation of excipients for stability, processability, biological action
    • Short-term stability studies on candidate formulation
    • Stability studies on GMP batch(es)
    • Harmonisation of Drug Substance/Drug Product analytical methods
  • GMP Manufacture
    • Selection of appropriate GMP manufacturer for clinical trials manufacturing and pharmaceutical analysis
    • Oversee confidentiality, commercial and technical agreements
    • Technology transfer
    • Set finished product specifications
    • Oversee/supervise first batch(es)
  • Review IMPD/IND CMC Sections

Phase 2-4

  • GMP API Drug Product Manufacture and scale-up
  • Technology transfer
  • GMP Drug Product Manufacture and scale-up
  • Revising Drug Substance and Drug Product Specifications
  • MAA/NDA review

Please contact us to see if we can help with the formulation development of your product.