Quality and Certifications
We are proud of our quality track record: GLP/GMP-certified, GCP compliant, inspected by EMA, FDA, relevant health authorities and periodic client audits. Our three EU sites are systematically monitored by Corporate Quality Assurance to uphold a unified quality system across the group. All analytical work and processes are regulated by Standard Operating Procedures (SOP) in compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) or Good Manufacturing Practices (GMP). A LIMS system is implemented for instruments integration, data integrity and traceability. We are Certified EU Importers of medicinal products with Quality Control managers for batch testing and Qualified Persons (QPs) for batch release certification.
Our latest FDA inspections were successfully completed on May 2020 (Kymos; FEI #3008661256) and April 2019 (Pharmaprogress; FEI #3002860914).
Kymos Certifications
Pharmaprogress Certifications
Prolytic Certifications
DG-GT Meeting: Dresden, DE | 10-11 Mar 2025
BIO CHINA 2025: Suzhou, CHN | 13-15 Mar 2025
BIO-Europe Spring: Milan, IT | 25-26 Mar 2025
German Pharm-Tox Summit: Hannover, DE | 25-28 Mar 2025
German Biotech Days: Heidelberg, DE | 09-10 Apr 2025
MEET2WIN: Bourdeaux, FR | 06-07 May 2025
BIO KOREA 2025: Seoul, KR | 07-09 May 2025
BIONNALE 2025: Berlin, DE | 14-15 May 2025
Innovation for Cell and Gene Therapies (ICGT): Paris, FR | 22 May 2025
MabDesign Partnering Day: Lyon, FR | 02 Jun 2025
Congrès Polepharma Biotesting: Evreux, FR | 04-05 Jun 2025
International Oligonucleotides and Peptides Conference: Prague, CZ | 09-11 Jun 2025
AFI Simposio: Rimini, IT | 11-13 Jun 2025
Antibody Industrial Symposium (AIS): Tours, FR | 25-26 Jun 2025
CPHI 2025: Frankfurt, DE | 28-30 Oct 2025
