Quality Assurance

Congratulations to our Client who successfully navigated a challenging licensing process to secure the coveted EU GMP certificate! Back in 2022, our Client approached us for assistance, having faced several unsuccessful attempts at obtaining the EU GMP certificate. Leveraging the expertise and insights of our seasoned auditors, we conducted a comprehensive factory audit, pinpointing areas of improvement. Drawing from our audit findings, we offered the Client a tailored set of recommendations for both corrective and preventive actions to rectify the identified shortcomings.

Through rigorous preparation and unwavering support, we stood by our Client during the pivotal inspection process. It's a moment of immense pride for us as we welcome yet another formidable pharmaceutical manufacturer into the dynamic landscape of the EU market. This achievement underscores our commitment to fostering excellence and adherence to the highest industry standards.

If you're seeking a trusted partner to navigate the complexities of regulatory compliance and achieve significant milestones, discover how our proven expertise can empower your journey towards success in the pharmaceutical realm.

Implementation of Quality Assurance

QP & RP advice

Provision of expert Qualified Person (QP) and Responsible Person (RP)

Risk Management

Implementation of the Quality Risk Management (QRM)

Validation

Support of the validation of manufacturing process, cleaning, computer systems, etc.

Serialization

Assistance in the implementation of the serialization and verification procedures

GMP Audits

Performing GMP Audit for the manufacturers of production materials (API, excipients, packaging, etc.) on behalf of the customers

Inspections Support

Preparation for GxP inspection and support during the official inspection

Strategic Advice

Preparation of SA on the types of production and distribution licenses.

QMS development

Complete development of QMS in accordance with the customer’s field of activity and the established regulatory requirements, i.e. production, distribution, laboratory, etc.

QMS implementation

Evaluation and implementation of existing QMS according to the requirements of the customer’s chosen commercialization target areas.

Pre-Inspection

Helping to accomplish a primary audit to establish the customer’s plant’s compliance with GMP requirements (pre-audit), indicating deficiencies and advising on the elimination of non-compliance (assistance in the implementation of CAPA).