A few words about us
Austrian Pharma Services offers multiple decades of combined experience helping Pharmaceutical and Biotech companies improve their compliance through hands-on service, training and consulting.
Our main areas of expertise are Quality Management Systems (per ISO9001, ISO13485, GDP, GMP per Eurdralex and 21CFR) - end-to-end.
Either you book us on a project basis or hire us as a Contract Quality Organization (Quality-as-a-Service).
Many companies face quality-related problems, that lead to citations from regulatory bodies, delaying the time-to-market.
We have found that most issues originate in losing sight of the bigger picture due to the daily grind. We can help by offering a fresh perspective and (re-)aligning quality goals with strategic ones.
Our services can help companies become more aware, improve quality, and manage suppliers more efficiently, reducing backlogs, compensating understaffing and lack of experience.
Services we provide to our customers
Quality System
We support young organizations in planning and implementing GMP-compliant Quality Systems (ISO9001, or ISO 13485) from scratch—customized, out--of-the-box or a QMS for rent, where we handle everything for you. Paper-based or cloud hosted and fully validated. Ask about QUASY.
Interim Management
We offer interim support in different management roles depending
on staff availability. Interim
Quality Lead/Manager/Director when a resource is out, or you cannot find a suitable permanent hire.
You can also hire us if you need to set up shop in Austria and you need a trade law-approved managing director, a responsible person.
Auditing Services and Supplier Management
We are Qualified Auditors per ISO 9001:2015, GMP, GDP, 21CFR820, 21CFR210/2011, EUDRALEX, ISO 13485, Pt.11 /Annex 11, respectively.We qualify your supplier, negotiate the quality agreements and follow-through open commitments.In case of large amount of suppliers and tight timelines we´ll leverage our partner company.
Training, Retainer, Near shoring
We´ll train your staff on GXP topics, develop your junior staff and support your business on a retainer basis if required.
Projects / or Backlogs
You are planning a project and don´t have internal resources? Your deadline approaches and you won´t make it? You have a backlog in CAPAs, Deviations, Change Controls, QAAs, or APQRs? We are having your back.
Customized Solutions
We are supporting you in finding efficiancy tools, ways to think about problems and solutions.
Innovation is inherent in our company and we strive to develope tools to serve our clients even better.
Our Partners
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