Analytical laboratory serving the pharmaceutical industry
The healthcare sector imposes regulatory and analytical requirements of absolute rigor. As a leading pharmaceutical analysis laboratory, FILAB provides you with the expertise of its PhDs, engineers, and technicians to decode complex issues related to molecular chemistry and material behavior (excipients, primary packaging, medical devices).
Chemistry and materials characterization: the expertise of our pharmaceutical analysis laboratory
Your need: to rely on a trusted analytical partner to validate the compliance of your inputs, characterize your material structures (packaging, medical devices), or resolve a complex chemical anomaly under the strictest regulatory requirements.
To meet this need, our analysis and characterization laboratory for the pharmaceutical industry offers a tailor-made approach combining materials characterization and analytical chemistry. Whether the goal is to secure your marketing authorization dossiers or handle an emergency in production, we turn your technical challenges into robust analytical protocols and GMP-compliant / BPF.
Our expertise in pharmaceutical analysis and quality control
From the development of your new dosage forms to the routine testing of your batches, FILAB combines top-level expertise with state-of-the-art analytical equipment.
- Validation of analytical methods specific to your products, according to the ICH Q2 reference standard.
- Identification and characterization of chemical impurities or isolated particulate contamination.
- Resolution of product behavior issues on your products under development or in production (degradation kinetics, color change, instability, odor drift, etc.).
- Deformulation of APIs (Active Pharmaceutical Ingredients) or complex finished products.
FILAB carries out expert assessments and analysis for the pharmaceutical industry
To secure your marketing authorization dossiers, validate your processes, or release your batches, our pharmaceutical testing laboratory deploys robust testing protocols aligned with the requirements of pharmacopoeias and health authorities (ANSM, EMA, FDA).
Pharmaceutical analytical and compliance testing
Nitrosamines are classified by IARC and the WHO as harmful compounds and likely to cause cancer in humans.
In addition, ANSM closely monitors them
Faced with the regulatory risk linked to mutagenic impurities, we provide screening and ultra-trace quantification (NDMA, NDSRI...) by LC-MS/MS and LC-Orbitrap. Secure your production with our expertise in nitrosamine analysis and quantification.
ICH Q3C provides guidance on acceptable toxicological thresholds for patient safety regarding residual solvent concentrations (or residual volatile impurities) in pharmaceutical products.
As the only quality control laboratory for the pharmaceutical industry in France accredited COFRAC ISO 17025 for this protocol, FILAB measures heavy metals (Classes 1 to 3) by ICP-MS on complex matrices. Trust us with your [analyse d'impuretés élémentaires selon l'ICH Q3D].The ICH Q3D guide establishes the procedure for assessing elemental impurities in pharmaceutical products, including those intended for human use
ICH Q3C provides guidance on acceptable toxicological thresholds for patient safety regarding residual solvent concentrations (or residual volatile impurities) in pharmaceutical products.
To ensure the safety of your products, we identify and quantify volatile impurities (Classes 1, 2 and 3) by GC-MS coupled with headspace analysis. Validate your raw materials through our residual solvent analysis service according to USP 467.
Since the structure of a powder determines the bioavailability of the active ingredient, we characterize your excipients and APIs (polymorphism by XRD, morphology by FE-SEM, particle size distribution). Discover our pharmaceutical solid characterization and analysis services.
Our advanced expertise and support for pharmaceutical R&D
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 particle size, shape, and distribution, which is particularly important for the pharmaceutical industry in controlling contamination in powders and injectable products
Beyond simple counting (USP <788>), our experts isolate and identify the exact nature and origin of contaminants in your powders or injectables using SEM-FEG EDX and micro-FTIR. Quickly resolve your production incidents with our expertise in particle contamination analysis.
FILAB’s laboratory follows the ICH Q3E guideline.
FILAB assesses container-content interactions (production lines, plastic packaging, medical devices) in accordance with the ICH Q3E guideline, BPOG protocols, and USP monographs <1663>, <1664>, <661> and <665>. Secure your regulatory files with a tailor-made extractables and leachables (E&L) study.
A forced degradation study tests the stability of pharmaceutical products/APIs to assess their behavior, purity, and compliance over time.
To anticipate the impurity profile of your active pharmaceutical ingredients (API) or finished products, we subject your molecules to controlled stress conditions (thermal, photolytic, oxidative, pH). Precisely map the behavior of your formulations thanks to our forced degradation studies for pharmaceutical products.
The ICH Q2 guideline governs the validation of analytical methods, developed by ICH experts and submitted to regulatory consultations.
In response to the emergence of new matrices, our pharmaceutical analysis laboratory develops, transfers, and validates specific and robust assay methods in accordance with the strict criteria of ICH Q2. Secure your future testing with our ICH Q2 analytical method validation service.
To ensure the safety and compliance of your raw materials, excipients, and finished products, FILAB carries out your routine analysis in accordance with Pharmacopoeia monographs (Ph. Eur., USP, BP). Secure the market launch of your products and ensure the continuity of your production flows with our quality control services for the pharmaceutical industry.
Filab supports you with training in analytical method validation for your teams
The FILAB laboratory is notably the only laboratory in France accredited ISO 17025 by COFRAC (www.cofrac.fr: accreditation no. 1-1793) for elemental impurity analysis in pharmaceutical matrices.
Our techniques
Organic chemical analysis
GC/MS, Py-GCMS, UPLC-MSMS, LC-QTOF-MS, LC-QTOF-MS, LC-ORBITRAP, GPC, NMR, FTIR
Powder analysis
XRD, SEM-FEG EDX, BET, Laser particle size analysis
Inorganic chemical analysis
ICP, DRX, CI
Thermal analysis
ATG, ATG-FTIR, DSC
Surface characterization
SEM-FEG EDX, XPS, TOF-SIMS
Ensuring your regulatory compliance: from development to batch release
From the validation of submission dossiers (MAA) for your new dosage forms to the routine testing of your commercial batches, FILAB secures every stage of your value chain in the face of health authority requirements (ANSM, FDA, EMA).
As a quality control laboratory for the pharmaceutical industry, we operate under a strict quality management system, rigorously compliant with GMP / BPF (Good Manufacturing Practices) criteria.
Our processes guarantee absolute traceability, compliance with Pharmacopoeia monographs (Ph. Eur., USP, BP), and the complete integrity of your analytical data (Data Integrity). By entrusting us with your analysis, you benefit from robust protocols (aligned with ICH Q2, Q3D, Q3E guidelines) that are essential for controlling the regulatory risk of your products.
Our FAQ
A pharmaceutical analysis laboratory provides essential scientific support to validate the chemical composition of products, characterize materials (packaging, devices) and ensure regulatory compliance. It works alongside your internal teams to carry out highly technical testing, from the research and development (R&D) phase through to the resolution of complex incidents.
Healthcare manufacturers call on external expertise when faced with specific technical challenges: a blockage during the development of a new formula, the appearance of an unknown impurity, an unexplained change in a product’s color or odor, or an urgent need to characterize materials in order to validate a new primary packaging supplier.
In a crisis situation (such as the presence of a suspicious particle in a batch), the FILAB laboratory deploys state-of-the-art tools (SEM-FEG, micro-FTIR, chromatography) to identify the exact nature of the failure. Determining whether it is a maintenance residue, plastic material degradation or external contamination makes it possible to quickly correct the industrial process.
Simply send us your specifications via our contact form or by phone. Our engineers review your needs (objectives, type of matrix, regulatory context) and send you a tailored technical and pricing proposal within 48 business hours.
Lead times vary depending on the nature of the analysis and the complexity of the expert assessment project.
FILAB is nevertheless committed to providing fast turnaround times tailored to your constraints and industrial urgencies.
Why trust FILAB laboratory for analysis serving the Pharmaceutical Industry?
Expérience industrielle
- Aerospace, energy, defense, metallurgy
- Chemicals, healthcare, medical devices
Un expert à votre contact
Pharmaceutical industry expert
Benoît Persin supports analytical projects for the pharmaceutical industry and medical devices.
Chemical and pharma analysis expert
Barbara Beauvais supports chemical analysis, quality control, and medical device projects.
What our clients say
"I used Filab for a chemical analysis. Very satisfied with the service. Responsive team, deadlines met, and a clear analysis report. I recommend them."
"Very responsive laboratory, with excellent analysis quality and deadlines met. Communication is smooth, the technical explanations are clear, and the team knows how to adapt to specific needs. I recommend them for their professionalism and reliability!"
"Clear and precise deliverable, delivered on time. I recommend them."
Where to find us and how to contact us
FILAB Laboratory
Ecoparc Dijon Bourgogne
80 rue Jean-Louis Auguste Petitjean
21850 Saint-Apollinaire, France
Tél. +33 (0)3 80 52 32 05
Request a quote
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