INTERNATIONAL LABORATORIES ORIENTED TOWARD INNOVATION.
Through our organization, we canvass mostly innovative national Anglo-Saxon laboratories which target their developments in specialty therapeutic fields or in medicines reserved for hospital use or affecting an orphan population.
We focus our interest on products with complex manufacturing, or requiring specific confinement conditions (HPAIs), with strong regulatory constraints that cater to niche markets, that is to say, with limited volumes and high added value for the Company but also for the Patient.
RELATIONS OF TRUST.
In the dynamic environment of the active pharmaceutical ingredient market, the first relationship that binds us is confidentiality, which encompasses all our exchanges, both internally and vis-à-vis our external partners.
Our commercial proposals … for close relationships:
We are committed to technical specifications and a development schedule, proposed according to the demands of the Customer and / or regulatory constraints related to the product whose master file must be made; representing 6-24 months of work. The related costs, which are distributed in installments over the stages of completion of the file, sometimes as costs shared between the customer and Seratec, aim to market the drug in which our material is to be incorporated.
Based on expected quantities and our production charge, a multiyear manufacturing contract, exclusive or not, is created. Each provision as part of documentary acceptability is subject to a quality certification which defines the rights and duties of the parties in all aspects related to GMP and beyond ...
… For prestigious Customers:
Seratec uses its expertise to develop molecules serving the interests of public health. By its experience, Seratec is qualified as a pilot laboratory for the development of new or rare and innovative molecules.
Our American clientele, among the world’s leading laboratories, and biotechs listed on the market are not wrong. Our services are not just common knowledge, these Customers are the recognition of Seratec’s added value to the expertise of one skilled in the art. More than a compliance tool, Seratec indeed anticipates technical requirements as new weapons for the improvement and the provision of new molecules.
Seratec has proven itself for over 15 years:
- In the development of a family of molecules around a chemical entity, which, after more than 10 years, resulted in a European registration under a procedure centralized at the EMA;
- In rapid availability of an API in the context of a supply shortage on the European market;
- In the chemical and pharmaceutical development of niche generics in the US market (ANDA);
- In the registration of over 10 master files (DMF, ASMF) for Seratec APIs, mostly for orphaned applications in Europe and the USA;
- In manufacturing under quality certification (QTA) with large pharmaceutical companies;
- In the registration of an sNDA in the US as part of a major variation concerning a polymorphic form of an API;