A successful marketing authorization campaign is only as good as its preceding development work

Our Services

Successful marketing authorizations of drug products are based on sound development planning. GW PharmaConsult offers services for development of solid dosage forms (immediate and modified release), especially tablets, multiple units, hard capsules and soft capsules, including scale-up to production.

  • Concept establishment
  • Formulation development
  • Technology transfer
  • Process optimization
  • Regulatory support
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Concepts for formulation development based on your regulatory strategy

  • Proof-of-Concept studies for evaluation of critical product attributes
  • Full formulation development according current ICH requirements
  • First-in-man concepts
  • Application of standard technologies for stringent manufacturing

Formulation development of solid dosage forms, mainly for (film-coated) tablets, pellets, hard capsules and soft capsules

  • Pre-formulation/early phase formulation development
  • Feasibility/Proof-of-Concept studies for evaluation of critical product attributes (e.g. formulation feasibility, processibility, pilot bioequivalence studies)
  • Full formulation development according ICH Q8/Q9/Q10 requirements
  • Development of combination products ( EP2645996)
  • Selection of CDMOs for product development
  • Concepts for bioavailability/bioequivalence studies
  • Clinical Trial Material manufacture according cGMP
  • Manufacturing scale-up to production
  • Manufacturing process validation

Formulation/manufacturing process optimization of existing drug products

  • Drug product adaptations considering optimization efficiency with minimum regulatory risk
  • Excipient selection, compatibility studies, reformulation
  • API stability and solubility, bioavailability enhancement
  • Manufacturing process robustness/processibility
  • Adaptation of manufacturing equipment and processing conditions

Technology transfer of existing drug products

  • Transfer planning and overall project management
  • Gap analysis of missing "state-of-the-art" documents for the current drug product
  • Establishment of constructive technological approaches for variation submissions
  • Selection of CMOs for product manufacturing (GMP certified)
  • Coordination of analytical method transfer
  • Process adaptation to available equipment
  • Manufacture of transfer batches and scale-up to production
  • Supervision of process validation and stability studies

Regulatory support for CTDs, ANDAs and IMPDs considering the ICHQ8/Q9/Q10 requirements

  • Technological concepts within variation submissions
  • Quality by Design studies
  • Concepts for comparative dissolution testing following EMA guideline on bioequivalence
  • Formulation development reports