- Provision of a contract Qualified Person (QP).
- Implementation of quality systems that comply with applicable standards for the pharmaceutical and medical device industries.
- Review of existing systems versus good manufacturing practice (GMP) by audit and risk assessment.
- Provision of gap analysis reports that highlight areas for improvement in existing systems.
- Updating of quality systems and related documentation to reflect industry and regulatory requirements with your input and tailored to your needs.
- Training of site personnel in revised systems.
- Initiation of continuous improvement programmes to ensure an ongoing focus on improved compliance at your site.
- Provision of a resource for a periodic system review.
- Provision of on-site resources to implement quality systems on a contract basis to suit your company requirements.