Confidence Beyond Compliance
Ensuring your internal systems, or those of your supplier or client meet the necessary requirements, is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.
A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical organizations to assure products’ pharmaceutical quality and patients’ safety. A well designed and efficient quality system will serve as a safe and sound basis for your business. It documents and verifies your approach for high quality products towards health agencies.
We have a broad spectrum of competencies in GxP quality management as well as in adjoining regulatory areas. This approach allows us to manage interfaces even in complex situations and provide additional value especially for small- and medium-sized organizations.
We offer advice, guidance and solutions in the following areas:
- Providing consultancy, gap analyses and operative support on GxP topics
- Designing, implementing and optimizing your GxP quality system
Preparing applications for manufacturing and wholesaling authorizations
- Designing and documenting processes as SOPs
- Implementing risk management approaches / FMEA analyses
- Planning and performing GxP audits and self-inspections
(incl. CAPA management)
- Preparing and supporting health agency inspections
- Supporting remediation activities