Aptus Clinical is committed to delivering quality, regulatory-compliant clinical research services in a professional, efficient, and cost-effective way, while protecting patient safety and data integrity for regulatory submissions. Our team is highly experienced in this heavily regulated environment and drive quality management, regulatory compliance and risk management in all projects.
Aptus Clinical offer support in the development of regulatory/GDPR documents, process and procedures that are ICH GCP compliant and are required for international drug development. We are committed to building successful partnerships, based on delivering the highest quality services in the most flexible and cost-efficient manner possible.
Aptus Clinical can deliver:
- Highly professional, fit for purpose QMS build using a cost-effective modular approach
- An exceptionally competent, experienced, and collaborative in-house team
- Clear advice on compliance strategies to align with global regulatory requirements
- Provision of insightful risk based operational advice
- Health authority audit preparation
- Conduct audits to GCP and GMP compliance and regulatory risk