Providing the benefits of differentiating technologies to PCAS customers
PCAS's industrial structure consists of flexible "multi-sites" for industrial implementation which leads rapidly to R&D fine-tuning, kilo-lab and pilot development. The organisation covers customers' potential needs by proposing a range of services required to develop a molecule throughout the clinical phases up to industrial product launch.
cGMP sites l Biocatalysts site l ISO-9001 sites l Headquarter
PCAS is supported by:
- A laboratory team supported itself by an analytical one, equipped with modern analytical tools at all sites, capable of carrying out and defining the first few grams of a product.
- Centralized sourcing and raw materials purchasing departments which handle over 1100 references.
- An industrial production capacity which places PCAS among the leading players in the worldwide market. Five cGMP sites, frequently inspected by official bodies (Medecines agencies)offering systematic back-up possibilities and back integration of intermediates manufactured at the 3 ISO 9001 sites. Confidentiality as well as guarantee of supply is certified throughout the manufacturing chain. FDA inspection of sites is a requirement to sell molecules to the USA.
- A Quality Assurance organization which guarantees site cGMP level by following carefully regulatory issues and a recognized system by official bodies such as the FDA, EMEA, AFSSAPS and Japanese PMDA (KIKO).
- A multi-disciplinary division dedicated to regulatory affairs authorization, based at Expansia site (Aramon), working in close and constant collaboration with PCAS team's development and manufacturing, customers, worldwide agencies and a network of experts for optimising regulatory lead-times.