Inspection Readiness

Ensuring compliance with Good Manufacturing Practices (GMP) is critical to maintaining product quality and regulatory approval in the biotech and pharmaceutical industries. Our GMP Inspection Readiness consultancy service at ViruSure is designed to help your organization prepare for successful regulatory inspections and audits.

Our team of experts offers comprehensive Mock Inspections and Gap Analysis to identify potential areas of non-compliance and recommend actionable improvements. By simulating real inspection scenarios, we help your team build confidence and readiness, minimizing the risk of costly findings.

We are specialized in Sterility Assurance and developing a robust Contamination Control Strategy in line with GMP Annex 1 requirements. Our approach ensures that your sterility protocols are fully aligned with the latest regulatory expectations, safeguarding your operations from contamination risks, and helping you maintain the highest standards of product quality and safety.

Partner with us to enhance your GMP compliance posture and ensure your team is fully prepared for regulatory scrutiny. With our tailored consultancy, you can achieve inspection readiness with confidence, knowing you have addressed every critical aspect of GMP requirements.

Angelika Spreitzhofer

Managing Director & Director QA

Angelika completed her studies at the Technical College for Chemistry in Graz, followed by post-graduate work at Donau University Krems. With more than 20 years of experience in the pharmaceutical industry, she has held roles at Baxter Healthcare, piChem, and the Austrian inspectorate for GLP/GMP inspections (AGES).
While at Baxter, Angelika worked across the Vaccine, Plasma, and Biosurgery divisions, focusing on molecular diagnostics, cell culture, and in-vivo virus and bacteria testing, and led an Analytical QC Laboratory. Furthermore, she contributed to piChem´s R&D department by establishing GMP systems, demonstrating her proficiency in quality management.
From 2005 to 2010, Angelika served as Lead Auditor for GLP and GMP inspections at AGES PharmMed. She managed inspections within Austria and worked closely with international organizations like the EMA, OECD, and WHO. Her role as an external expert for the WHO continues today, where she contributes to ensuring the safety of medical products in developing countries, particularly for critical therapies like AIDS, Malaria, and Tuberculosis.
In September 2010, Angelika joined ViruSure as Quality Manager, playing a vital role in maintaining and refining the company´s quality systems. Since April 2024, she has also taken on the responsibility of Managing Director, ensuring that ViruSure continues to deliver high-quality and reliable testing services. Her extensive experience in quality assurance and global collaboration makes her a trusted leader in the field.

Regine Tomasits

GMP Project Manager & QP

Regine earned her Biotechnology degree from the University of Natural Resources and Life Sciences, Vienna, in 1992. After initially focusing on vaccine development and protein purification at Immuno AG/Baxter AG, she quickly transitioned into leadership roles, managing the QC Microbiology Laboratory, and soon establishing and leading the Sterility Assurance Department. By 2004, she advanced to Senior Expert in Sterility Assurance, Cleaning, and Sterilization, playing a key role in Baxter´s international working groups. She successfully implemented LIMS, developed compliance strategies aligned with both national and international regulations, and represented her departments during inspections by regulatory authorities.
In 2005, Regine joined AGES as a GMP Inspector and Deputy Head of Pharmaceutical Inspections. As Head of National Inspections, she audited sterile manufacturing sites and collaborated with regulatory bodies like the EMA, EDQM, and WHO, ensuring compliance with global GMP standards. Her expertise grew to include Tissue Safety Act Inspections after completing specialized training at the University of Barcelona.
In her subsequent role as Qualified Person and Head of Product Release at Boehringer Ingelheim Austria, Regine optimized product release processes, handled quality complaints and defects, and maintained compliance through comprehensive product quality reviews. Her leadership in the field is highlighted by her position as a Board Member of the Austrian Qualified Person Association.
Since joining ViruSure in 2021, Regine has applied her extensive regulatory knowledge as GMP Project Manager and Qualified Person, offering clients expert guidance in ensuring product safety and regulatory compliance.