PRSG Pharmaceutical and Regulatory Services GmbH
Expert in Regulatory Affairs, Pharmacovigilance and Quality Management
Regulatory Affairs in Graz
PRSG is an Austria-based consulting company specializing in
Regulatory Affairs, Pharmacovigilance, and Quality Management for the pharmaceutical, biotechnology and medical device industries.
Our experienced team provides end-to-end regulatory support across the entire product lifecycle — from development to market authorization and post-marketing compliance. We assist clients with medicinal products, medical devices, food supplements, foods for special medical purposes (FSMPs), and cosmetics at both European and national levels.
At PRSG, our goal is to deliver high-quality, strategic, and operational consulting services that ensure compliance, efficiency, and patient safety. Through our expertise and dedication, we have built a strong reputation as a trusted partner for Regulatory Affairs Consulting and Pharmacovigilance Services in Austria and across Europe.
Our multidisciplinary team unites extensive experience in pharmaceutical and biotechnology regulations, compliance management, and technical development for biologics and pharmaceuticals — helping you navigate complex regulatory challenges with confidence.
Our Offers
Regulatory Affairs is an area of rapid change and ever-increasing demands. We are here to support you in this area, so you can focus on your core competencies and innovations.
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We advise.
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We offer tailored services.
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We step in when manpower is needed.
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We provide expertise.
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We live the hands-on philosophy.
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We are known for transparency.
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We place a high value on cost efficiency.
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We foster long-term partnerships built on trust.
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We act with integrity and responsibility.
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We deliver results — reliably and on time.
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We adapt quickly to changing challenges.
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We focus on sustainable and measurable success.
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We are always up to date.
Our Expertise
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Strategic consulting for medicinal products, marketing authorisations and market access
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Life Cycle Management
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Evaluation of regulatory or CMC documentation
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Dossier creation and preparation
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Quality management (GMP, GDP)
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Pharmacovigilance assistance
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Strategic consulting for the development and maintenance of medical devices, as well as advice for importers and distributors.
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Support for Food supplements and FSMPs in Europe
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Support for Cosmetics in Austria
Our Services
Strategic Consulting and Support
Marketing Authorisation Application
Dossier Compilation
Life Cycle Management
Literature Screening
Regulatory Intelligence
Reconciliation
Local Contact for Pharmacovigilance
Support for GMP / GDP Certification
QM System Set-up
Third Party Audits
Strategic and Regulatory Advice for importers and distributors
Compliance with the requirements of relevant regulations
Regulatory guidance on labelling compliance
Registration of Food Supplements in Europe
Support with Certification process
Regulatory guidance on labelling compliance
Preparation of Cosmetic Dossier
(product information file)
Support with notification process (CPNP)
EuDRAcon
EuDRAcon is a pan-European network of independent, national regulatory affairs consultancies. PRSG is the trusted member for Austria since 2013.
Founded in 2007, the networt provides:
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Unified Europe-wide support with local regulatory insight.
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A single point of contact for cross-border coordination.
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Fast, efficient and compliant market entry strategies.
EuDRAcon partners don’t believe in one-size-fits-all. Each member firm adapts to your company’s structure, product type, and market goals.
Network strengths:
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In-depth country-specific knowledge.
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Flexible collaboration models: from full-service.
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to niche consulting, from full project management.
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to work upon demand.
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Consistent quality standards across the network.
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Competitive, market-specific pricing.
