Analytical laboratory serving the Pharmaceutical Industry

More than 140 people
More than 140 people at your service
5200 m² laboratory
5200 m² laboratory + 99% of services are provided in-house
Accredited laboratory
Accredited laboratory COFRAC ISO 17025

Analysis and expertise in chemistry and materials for 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 pharmaceutical analysis needs thanks to their expertise in the pharmaceutical industry:

  • Implementation of an analysis method specific to your products, validated according to ICH Q2 standards
  • Identification of impurities or particles
  • Problems with the behaviour of one of your products (degradation, colour change, odour, etc.)
  • Deformation of an API or existing product

From the development of new galenic formulas to production control, 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 carries out analyses and expert reports for the pharmaceutical industry

As an extension of your in-house laboratories, the laboratory offers pharmaceutical manufacturers the following services:

Analysis

Our control analyses for the pharmaceutical industry

Nitrosamine analysis

Nitrosamines are classified by the IARC and the WHO as harmful compounds that can cause cancer in humans. They are also being closely monitored by ANSM.

Search for elementary impurities 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.

Analysis of residual solvents according to USP 467 (ICH Q3C context)

The ICH Q3C guideline provides guidance on toxicologically acceptable thresholds for patient safety with regard to concentrations of residual solvents (or residual volatile impurities) in pharmaceutical products.

Analyse du solide
Stability studies on pharmaceutical products and medicines
Expertise

Our expertise and R&D support

Particulate 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

Analysis of extractables and leachables is used to check the compliance of health products, assessing the risk of substances migrating from packaging.

Damage studies

A forced degradation study tests the stability of pharmaceutical products/APIs to assess their behaviour, purity and compliance over time.

ICH Q2 analytical validation and development

The ICH Q2 guideline guides the validation of analysis methods, drawn up by ICH experts and subject to regulatory consultation.

Quality control by rmn analysis
Training in validation of analytical methods

Filab can help you provide training in analytical method validation for your teams

Cofrac

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 techniques

Organic chemical analysis

GC/MS, Py-GCMS, UPLC-MSMS, LC-QTOF-MS, LC-QTOF-MS, LC-ORBITRAP, GPC, RMN, IRTF

Powder analysis

XRD, SEM-FEG EDX, BET, Laser Granulometry

Mineral chemical analysis

ICP, DRX, CI

Thermal analysis

ATG, ATG-FTIR, DSC

Surface characterisation

MEB-FEG EDX, XPS, TOF-SIMS

Our FAQs

The filab advantages
A highly qualified team
A highly qualified team
Responsiveness in responding to and processing requests
Responsiveness in responding to and processing requests
A COFRAC ISO 17025 accredited laboratory
A COFRAC ISO 17025 accredited laboratory
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
A complete analytical park of 5,200m²
A complete analytical park of 5,200m²
Tailor-made support
Tailor-made support
Contact us
To find out more about these services, don't hesitate
to contact our team.
Anaïs DECAUX Customer Support Manager
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