Know-how & Expertises

Analytical services

Our teams work to ensure you receive the best quality

Analysis and Quality Control

Every PiLeJe Industrie industrial facility has its own QA laboratory which carries out all the analytical tests required for release of your finished product. Our multi-disciplinary teams aim to meet your expectations in a wide range of areas:

– Quality approval of new raw materials.

– Making changes safe.

– Raw material regulatory watch.

– Raw material and finished product inspections.

– Assay of actives or finding contaminants.

Analytical Development

Our analytical development services support each step in the development of your product:

– Development & validation of assay techniques.

– Ingredient compatibility studies.

– Validation of the cleaning method.

– Validating the uniformity and robustness of manufacturing processes.

Stability Studies

We can offer tailored protocols for checking formulation stability and setting a best before date for your products. Depending on the matrix and end-delivery form we will perform the stability study on your product under the ICH conditions that apply to each country where it is going to be sold:

– Long term (25°C ± 2°C / 60% RH ± 5%).

– Intermediate (30°C ± 2°C / 65% RH ± 5%) or (30°C ± 2°C / 75% RH ± 5%).

– Accelerated (40°C ± 2°C 75% RH ± 5%).

A report is generated on each phase of the study so that potential optimisations can be suggested or packaging changes to guarantee that your customers always have the best possible perception of your products.

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