Michael Paar

Owner | Principal Consultant

Licensed pharmacist with over 16 years of experience in the pharmaceutical industry as Director of Quality Control and Director of Quality Assurance/Operations in the areas of GMP, GCP, and GDP.

Qualified person (since 2009 qualified according to § 15 (1) and § 15 (3a) (ATMPs) AMG)

Responsible person for controlled substances (BtM-V)

Location: Augsburg (Bavaria)

Areas of focus:
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establishment, evaluation, and optimization of quality management systems (GMP, GDP, GCP) and ensuring inspection readiness
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obtaining pharmaceutical regulatory permissions and certifications (manufacturing license, wholesale license, controlled substances license, GMP/GDP certificates)
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complex regulatory issues and communication with authorities (especially ATMPs and IMPs)
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assistance in the preparation of CMC parts of dossiers to apply clinical studies (INDs, IMPDs)
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auditing
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training
Michael Paar has been working in the pharmaceutical industry since 2007. From 2007 to 2019 he held various positions. Initially as Head of Quality Control and later as Director Quality Control as well as Director Quality Assurance/Operations and Qualified Person responsible for releasing active substances and medicinal products and maintaining QM systems.

Since 2015, he has been advising companies on various GxP-relevant issues and temporarily or permanently assumes the function as Qualified Person, head of QM/QA/QC, responsible person for pharmaceutical wholesale or as narcotics officer (BtM-V).

Michael Paar focuses on the establishment of QM- systems in the GxP environment, preparation, conduct, and follow-up of audits and inspections, training of employees and executives, as well as handling complex regulatory issues and communication with authorities.

The range of expertise includes chemical active substances and drugs as well as complex products (cell-based gene therapies, sterile drugs, DNA/RNA-based active substances) and products with special requirements (clinical trial supplies, medical cannabis and combination products)

Michael Paar is the owner of Paar Pharma Consulting, where he utilizes his extensive experience in the pharmaceutical industry to assist clients.

Headquarters of the company
Am Schönblick 8
86482 Aystetten

Augsburg branch
Annastr. 15
86150 Augsburg
Mobil: +49 (0)178 - 206 23 30

E-Mail: kontakt@paar-pharma-consulting.com

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