Synergy Health Utrecht is certified for:
- ISO 13485
- FDA inspected and approved
- WHO prequalified control laboratory
- Registration of drug product to MOH in Lebanon
- FAGG (Belgium)
- Restricted substances (opiates and drug-precursors license)
Synergy Health Utrecht adhere to strict quality standards in all its activities and we implemented the requirements for GMP and ISO 13485 many years ago. From the establishment of our company, more than 60 years ago, we have continuously been improving our quality management system (QMS). Through recommendations of many Customers, notified bodies and our own initiatives we achieved to have the best QMS suitable for a pharmaceutical Quality Control laboratory. The continuously successful certifications through the years are a results of the high quality of our services.
Our experts in Quality Assurance (QA) have many years of experience in and detailed knowledge of the establishment and maintenance of quality systems. To guarantee full regulatory compliance, Synergy Health’s QMS is in accordance with the rules of the Good Manufacturing Practice, as defined in EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines. To meet Customer satisfaction, we ensure timeliness, continuity and transparency in our QA system.
All employees are trained according to our training program internally and externally. Our Quality Management System (QMS) is an integrated system, based upon a comprehensive documentation system of Specifications, Standard Operating Procedures and is supported by qualified equipment, validated processes, analytical methods, and trained operators.
Although we offer a broad portfolio of testing services some tests we cannot perform ourselves. Cooperation with other GMP accredited laboratories is an opportunity but only possible after written approval from our Customer.