During his career Johan has developed himself being a pragmatic person, thinking in opportunities and solutions with an eye for detail. Before implementing a solution, he wants to have an overview on how the issue(s) that require attention, are part of the bigger picture. A solution should be an integrated compliant solution that works for everyone; as simple and clear as possible.
Havem Pharma Consultancy can provide support with:
- The design and management of Quality Management Systems (GMP, GDP, ISO9001, etc.) that fit with your organisation (size and structure);
- Management of Regulatory Inspections (FDA, EMA) and ISO9001 audits and follow up at your site(s);
- CMC documentation;
- Management of projects (e.g. from process development to commercial manufacturing);
- Management of Contract Parties;
- Training of your personnel;
- Execution of audits (internal, audits of suppliers or contract organisations);
- Provision of RP (Responsible Person) services acting in your capacity.
Upon completion of the assignment, your company can continue to work with the implemented sustainable solutions.