Analytical laboratory serving the Pharmaceutical Industry
The pharmaceutical sector is a world unto itself, with its own rules and codes. The FILAB laboratory fully understands this exceptional dimension. Our PhD students and engineers are trained to meet your specific needs for pharmaceutical analysis and expertise:
- Implementation of an analysis method specific to your products, validated to ICH Q2 standards
- Impurity or particle identification
- A behavioral problem with one of your products (degradation, color change, odor, etc.)
- Deformation of an existing API or product
From the development of new galenic formulas to the control of your production, the FILAB laboratory offers you high-level human skills and state-of-the-art analytical equipment to provide you with tailor-made services, in a quality environment that meets GMP criteria.
FILAB provides analysis and expertise
for the pharmaceutical industry.
As an extension of your in-house laboratories, the laboratory offers
pharmaceutical manufacturers with the following services:
Analysis
Our control analyses for the pharmaceutical industry
• Nitrosamine analysis
Nitrosamine analysis
Nitrosamines are classified by the IARC and WHO as harmful compounds that can cause cancer in humans. What's more, ANSM keeps a close eye on them.
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• Elemental impurity detection according to ICH Q3D
Elemental impurity detection according to ICH Q3D
The ICH Q3D guide sets out the procedure for assessing elemental impurities in pharmaceutical products, including those intended for human use.
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• Residual solvent analysis according to USP 467 (ICH Q3C context)
Residual solvent analysis according to USP 467 (ICH Q3C context)
The ICH Q3C guideline provides guidance on toxicologically acceptable thresholds for patient safety with regard to residual solvent concentrations (or residual volatile impurities) in pharmaceutical products.
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• Solid analysis
Solid analysis
Expertise
Our expertise and R&D support
• Particle contamination
Particle contamination
Particle counting is a crucial method for measuring and quantifying contaminants in various media, such as air, water and raw materials, and is vital in many scientific and industrial sectors. This technique provides detailed information on the size, shape and distribution of particles, which is particularly important for the pharmaceutical industry in monitoring the contamination of powders and injectable products.
• Extractibles & Relargable / stability study
Extractibles & Relargable / stability study
Analysis of extractables and leachables enables us to check the conformity of health products, assessing the risks of substance migration from packaging.
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• Degradation studies
Degradation studies
A forced degradation study tests the stability of pharmaceutical products/APIs to assess their behavior, purity and compliance over time.
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• ICH Q2 analytical validation and development
ICH Q2 analytical validation and development
The ICH Q2 guideline for the validation of analytical methods, drawn up by ICH experts and subject to regulatory consultation.
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In particular, FILAB is the only laboratory in France accredited to ISO 17025 by COFRAC (www.cofrac.fr: accreditation no. 1-1793) for the analysis of elemental impurities in pharmaceutical matrices.
Our technical resources
The filab advantages
A highly qualified team
Responsiveness in responding to and processing requests
A COFRAC ISO 17025 accredited laboratory
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
A complete analytical park of 2100m²
Tailor-made support
Contact us
To find out more about these services, don't hesitate
to contact our team.
Anaïs DECAUX
Customer Support Manager
Ask for your quote
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- Laboratory in support of the mirage teams
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- Packaging analysis laboratory for the pharmaceutical industry
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- Laboratory Analysis in the Pharmaceutical Industry
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- Forced degradation study in laboratory
- Laboratory analysis in line with GMPs
- Dissolution test of a drug in the laboratory
- Identification of particles in a pharmaceutical solution
- Laboratory analysis in accordance with official Pharmacopeias
- Stability testing on a drug or active ingredient (API) in a laboratory
- Excipient analysis laboratory for the pharmaceutical industry
- Laboratory analysis of pharmaceutical products intended for animal consumption
- Laboratory analysis of medications
- Pharmaceutical quality control analysis laboratory
- Laboratory analysis of pharmaceutical formulations
- Laboratory reverse engineering of a pharmaceutical product
- Forced degradation (stress testing) in a laboratory
- Residual solvent analysis of pharmaceutical products in accordance with the ICH Q3C guideline
- Laboratory analysis of active ingredients for the pharmaceutical industry
- ICP analysis laboratory for the pharmaceutical industry
