About Havem

Havem Pharma Consultancy was founded by Johan Hamminga to deliver quality services to the pharmaceutical industry. Johan is a senior Life Science consultant with more than 25 years of experience within the Biotech and (Bio)pharmaceutical industry. He has a successful track record in a variety of roles: Director, Senior Project Manager, Quality Subject Matter Expert. In these roles he has worked for large established companies as well as for startups.

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.