FDA-registered laboratory (Pharmaceutical sector)

Chemical analysis Problem solving R&D support
More than 140 people
More than 140 people at your service
5200 m² laboratory
5200 m² laboratory + 99% of services are provided in-house
+2200 clients
+2200 clients in France and abroad

As a manufacturer, you would like to export your pharmaceutical products to the USA

The FDA regulates access to pharmaceutical products in the USA

The FDA (Food and Drug Administration) is the U.S. federal agency responsible for protecting and promoting public health. Its primary mission is to regulate and oversee the safety and efficacy of food products, drugs, medical devices, cosmetics, biological products, and more. The FDA ensures that consumer products are safe, effective, and properly labeled.

Control the conformity of your medications

Non-compliance of the drug (presence of impurities, interaction between the active ingredient and excipients) could lead to the drug being denied marketing authorization or even withdrawn from the market.

To meet these technical challenges and export your products to the USA, you are looking for a reliable and responsive pharmaceutical analysis laboratory capable of supporting you with the analyses required by the FDA.

FILAB laboratory is registered with the FDA and assists you with the analysis of your pharmaceutical products exported to the USA

Why choose FILAB for your drug and pharmaceutical product analysis exported to the USA?

FILAB is an FDA-registered laboratory that supports pharmaceutical companies exporting their products to the USA, who are required to have their products analyzed by an FDA-registered laboratory.

FILAB offers pharmaceutical companies highly skilled personnel and state-of-the-art analytical resources to provide services that meet FDA compliance requirements.

Furthermore, FILAB is the only laboratory in France accredited to ISO 17025 by COFRAC (www.cofrac.fr: accreditation no. 1-1793) for elemental impurity analysis in pharmaceutical matrices and performs drug analysis according to GMP standards.

Our technical resources for the analysis of medicines and pharmaceutical products

Organic analysis : GCMS, Py-GCMS, LC-MSMS, GPC, NMR, FTIR

Thermal analysis : TGA, DSC

Powder analysis : XRD, SEM-FEG EDX, BET

Mineral analysis : ICP, XRD, IC

Metallurgical analysis : ICP, SEM-FEG EDX, SEO

Surface analysis : SEM-FEG EDX, PES, ToF-SIMS

Our services for analyzing drugs and pharmaceutical products

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 facility of 5,200m²
A complete analytical facility of 5,200m²
Tailor-made support
Tailor-made support
Video debriefing available with the expert
Video debriefing available with the expert
Anaïs DECAUX Customer Support Manager
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