Analytical development for the pharmaceutical industry
Why use analytical development in the pharmaceutical industry?
In the Health sector (Pharmaceutical or Medical Devices), analytical development is a key factor allowing :
To ensure the content of an active ingredient (API) within given specifications
Validate the safety and quality of the product in the context of product monitoring
To do this, the analytical research and development laboratory must take charge of the different stages of the development of an analytical method.
How to develop an analytical method in the pharmaceutical industry?
To develop an analytical method in the pharmaceutical industry, it is necessary to use a research and development laboratory. The FILAB laboratory offers you an analytical development methodology based on the following points
- Bibliographic study, definition of the methodology
- Choice of technique and analytical method
- Feasibility study
- Isolation of the analyte
- Purification
- Development of the analytical method
- Verification of parameters
- Analytical optimization
- Analytical validation
- Implementation of a dedicated operating procedure
I contact the FILAB laboratory for an analytical development
FILAB laboratory: specialized in analytical development for the pharmaceutical industry
FILAB's unique experience in pharmaceutical analytical development
For many years, FILAB’s experts have been trained in the specificities of the pharmaceutical sector. Indeed, each of our PhD students and specialized engineers is fully aware of the unique needs of your industry and the regulatory standards you must meet. Thus, we offer you a tailor-made support for the analytical development of your pharmaceutical products.
Thanks to these internal skills, we have already worked on the development of the following analytical methods for pharmaceutical raw materials or finished products:
- Development of a method for the analysis of an impurity / degradation product in a pharmaceutical tablet
- Analytical development for the analysis of elemental impurities in accordance with the ICH Q3D guideline, USP 232 and USP 233
- Implementation of a method for the analysis of substances potentially released from packaging:
- Extractable and Relargable Studies and Container-
- Content Interactions
- Development of an analytical method for the determination of antibiotics present in a surface treatment of a prosthesis (medical device)
- Development of an analytical method for the determination of an anti-aging active ingredient in a formulation (medical device)
To develop a specific analytical method, FILAB mobilizes the skills of its best specialists who are entirely dedicated to your file. You can therefore exchange with the same people until the end.
Why choose FILAB for your analytical developments?
And if, after all these arguments, you are still hesitating, you should know that the FILAB laboratory is an approved training organization. This means that we can assist you in transferring an analytical method to your own laboratory through customized training services. The objective: to provide you with a robust turnkey analytical method!
Consult our Pharmaceutical Industry brochure
Consult our Medical Devices brochure
FILAB also provides the following services
- Biocompatibility studies according to ISO 10993 ( -18 / -12 / -13 / -14 / -15 / -19 / -22 )
- R&D support: custom chemical analysis, material and surface characterization, analytical development
- Problem solving: non-conformity, breakage, adhesion, corrosion…
- Process validation: Cleaning (ISO 19227), surface treatment
