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
KOREA PHARM & BIO: Goyang, KR | 23-26 Apr 2024
BIO KOREA 2024: Seoul, KR | 08-10 May 2024
BIO International Convention: San Diego, US | 3-6 Jun 2024
Congrès POLEPHARMA Biotesting: Évreux, FR | 5-6 Jun 2024
AFI Symposium: Rimini, IT | 5-7 Jun 2024
BIOPLUS – INTERPHEX KOREA: Seoul, KR | 10-12 Jul 2024
Farmaforum: Madrid, ES | 25-26 Sep 2024
Biomarkers Europe 2024: Basel, CH | 30 Sep – 01 Oct 2024
CPHI 2024: Milan, IT | 8-10 Oct 2024
European Bioanalysis Forum: Barcelona, ES | 20-22 Nov 2024
PharmaLab Congress: Düsseldorf, DE | 25-27 Nov 2024
I4ID 2024: Lyon, FR | 27-28 Nov 2024
