Pharmasupport
PharmaSupport provides hands-on consulting and operational support to companies in the pharmaceutical and biotechnology industries. Our focus is on the development, optimization, and management of quality management systems (QMS) according to GMP, GDP, and ISO 9001 – tailored, efficient, and regulatory-compliant. We support you in obtaining wholesale and manufacturing licenses, as well as in preparing for and handling inspections by local authorities or international bodies such as the FDA. Our experienced experts ensure that you meet regulatory requirements with confidence – through professional planning, documentation, and audit support. In addition to building effective QMS structures, we take on key roles – either on an interim or permanent basis – such as Qualified Person (§14 AMG), QPPV, or Information Officer. Our professionals integrate seamlessly into your team and ensure compliance and process stability. In pharmacovigilance, we offer comprehensive support – from signal management and literature screening to the preparation of regulatory documentation. We also provide expertise for technical GMP projects, including facility upgrades, technology transfers, and equipment qualification and validation. Our interim managers take on leadership responsibility during critical phases – whether in quality assurance, plant management, or pharmacovigilance. In addition, we support you with audit preparation, regulatory due diligence, and SOP development – flexible, solution-oriented, and reliable. PharmaSupport – Quality. Expertise. Responsibility.
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