Compliance with regulations forms the cornerstone of your project and we ensure quality at all stages of manufacture.
Our Weert (The Netherlands) and Prague (Czech Republic) facilities are GMP certified and FDA inspected.
Our Quality Management System (QMS) is in place to guarantee compliance to all required elements of GMP, such as those described in the ICH Q7 guidelines and Eudralex, Vol. 4.
Our Quality Assurance (QA) and Quality Control (QC) departments are responsible for ensuring that all finished products are manufactured in accordance with relevant procedures, requirements, and specifications, in line with cGMP guidelines and client-specific quality agreements.
Our employees are trained to develop a strong compliance mindset to guarantee product assurance and adherence to regulations. A mentality of continuous improvement is embedded in our organization.
Discover Exemplify
We deliver a number of services in partnership with Exemplify BioPharma, a global Partnership Research Organization (PRO) offering end-to-end CMC solutions under one roof.
Exemplify offers:
- Integrated project management across Process Chemistry, Analytical Chemistry, and Formulation Development
- Expert oversight on CRO/CMO selection, contracting, and management
- Comprehensive support with CMC regulatory submissions (IND, IMPD, NDA, MAA)
- Full Quality Assurance and compliance sign-off
- Efficient timeline and budget management
Their newly expanded Formulation Suite also opens the door to enhanced formulation capabilities, strengthening support from early development through to commercialization.
