Analytical Development

Analytical Development Services

Analytical method development in a limited time

Product development is closely supported by an experienced analytical team during every phase of the development process. This team has expertise in method development and experience in issue management allowing them to proactively manage the issues that might arise and resolve them.

Thanks to this expertise we are able to develop analytical methods in a limited time, from bibliography study, screening parameters and conditions to sample preparation and assessment of robustness.

Skyepharma - Analytical development technician
  • Bibliography studies
  • Analytical method development and validation according to ICHQ2 guideline
  • ICHQ3D guideline for related substances of new finished formulation.
  • Analytical method transfer
  • Process optimization
  • Registration and commercial stability study
  • Qualification of secondary standards
  • Cleaning method development and validation
  • Writing of documentation (reports and protocols)
  • Analysis of all R&D samples and technical batches
  • Follow-up of the analysis of the prototyping formulation during the early stage development
  • Evaluation of the deterrent properties of formulations, recommended by recent regulatory guidelines.
  • Special support services such as high storage capacities for stability studies : 19 rooms (conditions ICH 25/60 30/65 40/75 30/75, and refrigerated conditions)
  • Method development and method optimization (such as liquid chromatography)
  • Identification by Mass Spectrometry (Q-TOF)
  • Characterization of powders with BET / Particle size analyzer
  • Infrastructure suitable for the handling of narcotic drugs or controlled substances.
  • Laboratory rooms equipped with yellow light for handling photosensitive compounds

From development to production

We prioritize agility and expertise without compromising on product quality :

Skyepharma CDMO Analytical activities
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