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

 

info@pbc-unterlinner.com

www.pbc-unterlinner.com

 

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.

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Interim Management

Assumption of senior and operational roles in restructuring, quality assurance, manufacturing, quality control, supply chain management, and regulatory affairs (CMC review).

 

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Quality Assurance and Quality Management

Support in establishing, updating, and transforming quality systems, as well as conducting technical due diligence during acquisitions and mergers.

 

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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).

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Internal and External Audits

Conducting audits in production, development, clinical studies, and quality systems in accordance with national and international standards, including CAPA management.

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Support During Regulatory Inspections

Guidance and representation during inspections, from preparation through the inspection to follow-up, including communication with authorities and mock audits.

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Project Management

Comprehensive project control from planning to commissioning, including qualification documentation, validation of processes and systems, product and process transfer, and regulatory approval.

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