Established in 1983, this company set up a team and a laboratory structure able to offer assistance to pharmaceutical companies (generic or innovative) looking for professional and qualified help.

The company proposes its services in 3 main areas:
- As a laboratory, they have an in-depth expertise and know-how on European Pharmacopoeial activities including, but not limited to compliant sterility testing with often complex biological matrixes.

All testing is performed according to GMP (Good Manufacturing Practices) requirements and international recognized standard (the company follows the ISO 17025 standard).

The main activities are pharmaceutical analysis, mainly in the chemical, physicochemical, bacteriological and toxicological fields. As a laboratory, they are accredited by the Belgian Health Authorities and offer qualified services for pharmaceutical batch release to the European market.

The laboratory proposes as well its expertise on the investigation of the stability and shelf-life of a pharmaceutical product. Stability studies are conducted according to the highest quality standards and in full accordance with all regulatory requirements.

As a laboratory, they offer as well storage conditions in accordance with ICH (International Conference on Harmonisation) guidance:
5°C
25°C 60%RH
30°C 65%RH
40°C 75%RH

The company has an extensive knowledge and expertise in developing and validating methods for both raw materials and finished products. They offer development and documentation of analytical protocols for proprietary and non-proprietary test methods and manufacturing processes in compliance with the last official standards in vigour such as ICH.

Study items include:
" specificity with regards to the impurities, degradation products (eventually obtained after forced degradation) and the matrix" linearity" accuracy" precision repeatability" detection limit" quantitation limit" potency stability

- As Regulatory Affairs company, they have an in-depth expertise in establishing contacts with health authorities. They have been helping local Belgian, European and non-European pharmaceutical companies in the different administrative, pharmaceutical and clinical steps for the compilation and follow-up of drug dossiers, according to both the local (Belgian) and European Procedures.

- As a Consultancy company, they have developed their activities in the following domains: pharmaceutical counseling, in accordance with Good Manufacturing Practices (GMP) and the validation of pharmaceutical premises or manufacturing processes, cosmetics and foodstuffs with training, audit, and follow-up of companies in HACCP plans.

Innovative Aspects:
One-stop-shop from initial concept till final release of drug product to the market.
Small and innovative pharmaceutical contract laboratory, with in-depth and hands-on experience in European Pharmacopoeial testing, including microbiological testing.

Experienced staff with international exposure.

 

Patents/Rights: Secret know-how

Type of Organisation: