FDA-registered laboratory (Pharmaceutical Sector)
As a manufacturer, you want to export your pharmaceutical products to the USA
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 drugs
Pharmaceutical manufacturers of human and animal health products (generics, injectable solutions, etc.) are faced with numerous quality requirements linked to these products. These requirements apply both during the process of bringing the drug to market, and during its life cycle. These strict regulations oblige you to carry out numerous quality controls on your drugs, in accordance with well-defined standards such as the pharmacopoeia.
Non-compliance (presence of impurities, active ingredient/excipient interaction) could result in the drug not being approved for marketing, or being withdrawn from the market.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, able to supporting you in the analysis required by the FDA.
The FILAB laboratory is registered with the FDA and can help you analyse your pharmaceutical products for export to the USA.
Why choose FILAB for your analysis of drugs and pharmaceutical products exported to the USA ?
FILAB is an FDA-registered laboratory and supports manufacturers exporting pharmaceutical products to the USA, who are required to have their products analysed by an FDA-registered laboratory.
FILAB provides pharmaceutical manufacturers with top-level human skills and state-of-the-art analytical equipment to offer them services that meet their compliance criteria, in compliance with regulatory standards, for all types of drugs and dosage forms.
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, and performs GMP-compliant drug analysis.
Our analysis services for drugs and pharmaceutical products
FILAB offers pharmaceutical manufacturers tailor-made support for drug analysis:
Chemical analysis of drugs by GC-MS, LC-MS, ICP...
Particle analysis of your drugs (troubleshooting) by SEM-EDX, FTIR, LC-MSMS...
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²
Tailor-made support
