Your Partner in Pharma and Life Science
Pharma & Biotech Consulting – Dr. Bernhard Unterlinner is your partner for Pharma and Life Science.
We support and advise you in the areas of quality assurance, quality management, and manufacturing of pharmaceuticals and biopharmaceuticals/biosimilars.
In the fields of Pharma and Biotech, we take on interim management roles, lead projects, conduct internal and external audits, and oversee regulatory inspections (EMA, FDA, national authorities).
We assume roles as “Qualified Person” according to §14 AMG ("Qualified Person"), and “Responsible Person” according to §52a AMG ("Responsible Person").
We can provide additional resources and expertise from our network if required.
Contact
Pharma & Biotech Consulting
Dr. B. Unterlinner
Am Kapuzinerhoelzl 43a
80992 Munich
Germany
+49 (0)179 2248796
We solve tasks and meet expectations
Qualified Person / Responsible Person
Assumption of roles as Qualified Person, Responsible Person, and Head of Manufacturing and Quality Control. We ensure that all regulatory requirements are met efficiently and reliably.
Interim Management
Assumption of senior and operational roles in restructuring, quality assurance, manufacturing, quality control, supply chain management, and regulatory affairs (CMC review).
Quality Assurance and Quality Management
Support in establishing, updating, and transforming quality systems, as well as conducting technical due diligence during acquisitions and mergers.
Production
Management and operational implementation in the manufacturing and packaging of traditional and biopharmaceutical drugs, as well as clinical trial materials, including sterile and aseptic processes and serialization (Track and Trace).
Internal and External Audits
Conducting audits in production, development, clinical studies, and quality systems in accordance with national and international standards, including CAPA management.
Support During Regulatory Inspections
Guidance and representation during inspections, from preparation through the inspection to follow-up, including communication with authorities and mock audits.
Project Management
Comprehensive project control from planning to commissioning, including qualification documentation, validation of processes and systems, product and process transfer, and regulatory approval.