- Assay method development or variation (HPLC, spectrophotometer, TLC, burette)
- Assay method transfer
- Dissolution method development or variation (USP2- USP4)
- Dissolution method transfer
- Development of HPLC method for dissolution
- Development of spectrometric method for dissolution
- Water content method development.
- Assay method validation according to ICH Q2R
- Validation of HPLC and spectrometric method for dissolution
- Data analysis using a 21CFR part 11 software (e-Noval)
- Analysis of customer data
In vivo assessments
- Ex vivo: transdermal and transmucosal permeation using biopsies
- In vivo: administration to rats, rabbits or mini-pigs of injectable depot (microspheres, implants and microcrystals), buccal bioadhesive tablets, nasal solutions and transdermal gels and creams.
- Development of LC-MS assays