Regulatory strategy and in-time feasibility checks lay the foundation for successful products

Our Experience and Specialisation

The service portfolio from GW PharmaConsult builds on 30 years of experience from the pharmaceutical industry. This experience covers areas such as Proof-of-Concept or feasibility studies and full formulation development, but also more specialized areas such as first-in-man concepts and development of combination products.

Our professional consulting services are based on a solid scientific foundation, but also on a sharp focus on how to avoid deviations and risks, and the ability to provide efficient, creative and reliable solutions with regulatory success at the end.

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Pharmaceutical development

  • Pre-formulation/early phase formulation development (e.g. compatibility studies, temperature/pH challenge tests, open dish studies, temperature cycling studies)
  • First-in-man concepts with simple formulations
  • Stepwise formulation development to minimize the development risks
    Step 1: Feasibility/Proof-of-Concept studies (evaluation of critical product attributes)
    Step 2: Full development according ICHQ8/Q9/Q10 requirements
  • Generic formulation development including combination-preparations (e.g. ibuprofen/pseudoephedrine, diclofenac/omeprazole ( EP2645996)
  • Concepts for bioavailability/bioequivalence studies including comparative dissolution testing following EMA guideline on bioequivalence
  • Clinical Trial Material manufacture according cGMP
  • Scale-up to production, technology transfer
  • Process optimization (robustness, processibility, API stability)
  • Manufacturing process validation
  • Formulation development reports as basis for IMPDs, ANDAs and CTDs

Project management

  • Project management for own, co-development and customer fee for service projects
  • International project management for formulation development within “big pharma”
  • Project management for early stage NCE developments as ”standard tablets“ or “simple formulations” for Proof-of-Concept clinical studies
  • Project management for external formulation development of Self (Micro)Emulsifying Drug Delivery Systems (SMEDDS, SEDDS)

Manufacturing processes

  • High shear mixing/granulation
  • Thermoplastic granulation
  • Pelletizing
  • High shear homogenization
  • Roller milling
  • Blending
  • Tabletting
  • Fluid bed coating
  • Pan coating (soft capsules and tablets)
  • Rotary die encapsulation
  • Microencapsulation

Dosage forms

Solid dosage forms Semisolid / liquid dosage forms
  • Drops, solutions, suspensions, syrups (oral administration)
  • Sachets for ready-to-use preparations (oral administration)
  • Ointments, creams and gels (dermal administration)
Special experience for
  • Soft capsules
  • Multiple unit dosage forms
  • Enteric coatings

Drug substances

Generic drug substances
  • Ibuprofen, diclofenac-sodium, omeprazole, theophylline, carbamazepine, glibenclamide, acetylsalicylic acid, acetaminophen, codein phosphate, noscapine, caffeine, pseudoephedrine, methylephedrine, diphenhydramine, torasemide, duloxetine, methylphenidate, nilvadipine, dutasteride, cholecalciferol, calcitriol, ergocalciferol, isotretinoine, dronabinol, peppermint oil
Plant extracts
  • Ginkgo biloba dry extract, bearberry leaf dry extract, horse-chestnut seed dry extract
Several NCEs for peroral and dermal application