Quality is our highest priority. As industry leaders, it is built into everything we do and is an area of continuous focus and investment.
For our clients, we provide solution-driven, appropriately engineered and skillfully tailored regulatory approaches. Our experts think creatively and work within regulatory guidelines, to deliver practical, compliant solutions.
Our team has deep expertise and broad experience in dealing with global regulatory authorities and consulting clients, from large pharma to virtual start-ups.
Quality Management System (QMS)
Our full suite QMS, QualityOne, helps ensure we operate to a consistently high and harmonized standard to meet the needs of a global market.
Implemented across our global network of GMP facilities, QualityOne unifies our approach, strengthens compliance and decision-making and enables us to provide enhanced document management, electronic change control capability, corrective and preventive action (CAPA) and deviation management.
Every member of our team is committed to delivering impeccable standards and results.
We have developed programs to certify staff in quality principles and created numerous dedicated roles within our organization.
Ongoing training is in place for all our associates. Specific to their job and functional areas, our training programs ensure associates are well versed in all aspects of quality, its importance and how all our people contribute to quality assurance.
All starting materials are checked by trained quality control personnel at incoming against specifications to ensure quality and any deficient lots are quarantined.
Testing on packaged products is performed by certified teams and the results are documented in the batch record and reviewed by our quality department prior to release.
We have a deep commitment to quality, exceptional credentials and a history of strong regulatory compliance.
Our quality credentials
- US Food and Drug Administration (FDA) registered and inspected
- US Drug Enforcement Agency (DEA) registered and inspected
- European Medicines Agency (EMA) approved
- Brazilian National Health Surveillance Agency (ANVISA) approved
- UK Medicines and Healthcare Products Regulatory Agency (MHRA) approved
- Russian The State Institute of Drugs and Good Practices (FSI SID&GP) approved
- Turkish Medicine and Medical Devices Authority (TİTCK) approved
- Australian Therapeutic Goods Administration (TGA) approved