Experienced GMP consultants for pharma and biotech

Dr. rer. nat. Hans-Georg Eckert, Biologist

Senior GMP-Berater/-Projektmanager & GMP-Auditor

Over 25 years of professional experience and GMP consulting in the pharmaceutical and biotechnological industry

• Specialized on GMP requirements and problem solving in the pharmaceutical and biotechnology industry with more than 200 successfully completed consulting and compliance projects
• With special focus on GMP-compliant manufacturing of ATMPs (Advanced Therapy Medicinal Products) since 1997
• Formerly Head of Production (acc. to § 15 AMG/acc. to §. 12, para 1, sentence 3 AMWVH and EU GMP Guideline Part I, 2.7), Project Manager as person in charge of the Genetic Engineering Safety Ordinance (§ 15 GenTSV), holder of a permit to handle pathogenic substances (acc. to § 44 lfSG, incl. organisms with BSL 3 ** classification) and person in charge of pharmacovigilance
• More than 80 congress contributions as speaker and organizer

Core competencies: GMP consulting, concepts and solutions, project and quality management, execution of GMP audits, GAP analyses and GMP training

Leader of the Valicare expert team for ATMPs and GMP expert for plant and automation concepts, up- and out-scaling in this business area

Dr. rer. nat. Carsten Börger (Chemist)

Senior GMP Project Manager and GMP Auditor

Over 15 years of professional experience in the pharmaceutical and biotechnology industry

• Qualification and validation of GMP-compliant pharmaceutical equipment (production and quality control)
• Specialized in the validation of computerized systems (CSV), cleaning validation, method validation, the establishment and optimization of GMP systems
• Formerly Head of Production (acc. to Art. 12, para 1, sentence 3 German AMWVH and EU GMP Guideline Part II)
• More than 30 scientific publications
• More than 100 GMP projects in pharmaceutical and biotechnological production: manufacturing, qualification and validation of finished pharmaceuticals, APIs and excipients

Core competencies: GMP consulting, project and quality management, qualification & validation, execution of GMP audits, GAP analyses and GMP training

Dr. rer. nat. Stefan Löffler

Senior GMP-Consultant

10 years of professional experience in basic biomedical research, CMC project management & GMP consulting in the pharmaceutical industry.

Specialized in:

• CMC project management for the coordination of manufacturing processes, quality control and regulatory requirements in the context of pharmaceutical development
• Preparation of pharmaceutical documentation for the development, production and quality control of pharmaceuticals as well as for the qualification and validation of plants, equipment and processes (risk analyses, master plans, protocols & reports, etc.)
• Analysis (gap audits), updating and implementation of pharmaceutical quality management systems
• Since 2023, special focus on the production of novel therapies (ATMPs).

Core competencies: GMP consulting, concept and problem solving, project and quality management, contamination control, biosafety, GAP analyses and GMP training on the topic of ATMPs

Deputy Head of the Valicare Expert Team for ATMPs