# Austrian Pharma Services FlexCo > Senior consulting firm for Pharma, Biotech and Medical Device companies in the DACH region. Founded 2018 in Austria. Specialised in GMP compliance, quality management systems, inspection readiness, eQMS implementation, technology transfer and interim quality management. ## Company - **Legal name:** Austrian Pharma Services FlexCo - **Address:** Garnei 161/2, 5431 Kuchl, Austria - **VAT-ID:** ATU81450467 - **Email:** office@austrianpharmaservices.com - **Phone:** +43 680 44220099 - **Website:** https://www.austrianpharmaservices.com - **LinkedIn:** https://www.linkedin.com/company/82297020/ - **Languages:** German, English - **Areas served:** Austria, Germany, Switzerland (DACH region) ## Mission We help pharmaceutical, biotechnology and medical device companies build, mature and defend their quality systems – from first GMP audit through routine authority inspections. ## Services ### Quality Management Systems (QMS) Design, implementation and improvement of GMP-compliant quality management systems for pharmaceutical, biotech and medical device manufacturers. Includes documentation structure, SOP architecture, deviation, CAPA and change management. ### Inspection Readiness Preparation for authority inspections (BASG, EMA, FDA, Swissmedic, notified bodies). Gap assessment, mock inspections, training of staff, document review, on-site support during inspection. ### eQMS Implementation Selection, configuration and validation of electronic quality management systems. Migration from paper-based to digital QMS. Computerised System Validation (CSV) according to GAMP5 and Annex 11. ### Technology Transfer Transfer of products, processes and analytical methods between sites or to CMOs/CDMOs. Risk-based approach, comparability protocols, qualification and validation strategy. ### Interim Quality Management Senior interim QPs, Quality Managers and Heads of QA for bridging vacancies, project peaks or transformation phases. ### Regulatory Affairs Support Support for variations, renewals, MDR/IVDR technical documentation, regulatory strategy in the DACH region. ## Approach - Senior-only delivery: every project led by experts with 15+ years of industry and authority background. - Risk- and outcome-based: aligned with ICH Q9, ICH Q10 and EU GMP Part I/II/III. - On-site or remote across the DACH region. - No off-shore juniors, no slide decks instead of hands-on work. ## Industries served - Pharmaceutical manufacturing (small molecules, biologics, ATMPs) - Biotechnology - Medical devices (MDR / IVDR) - API and excipient manufacturing - Contract manufacturing organisations (CMO / CDMO) ## Regulatory frameworks covered - EU GMP Guide (Part I, II, III and Annexes) - ICH Q7, Q8, Q9, Q10, Q11, Q12 - 21 CFR Part 11 / Part 210 / Part 211 - EU MDR 2017/745 and IVDR 2017/746 - ISO 13485, ISO 14971 - GAMP 5 / Annex 11 - AMG, MPG, AMWHV (national Austrian/German law) ## Content resources - **Blog & Insights:** https://www.austrianpharmaservices.com/insights/ - **Regulatory Dashboard:** https://www.austrianpharmaservices.com/regulatorisches-dashboard/ - **Services overview:** https://www.austrianpharmaservices.com/leistungen/ - **About us:** https://www.austrianpharmaservices.com/ueber-uns/ - **Contact:** https://www.austrianpharmaservices.com/kontakt/ ## English versions - Home: https://www.austrianpharmaservices.com/en/ - Services: https://www.austrianpharmaservices.com/en/services/ - About: https://www.austrianpharmaservices.com/en/about-us/ - Contact: https://www.austrianpharmaservices.com/en/contact/ - Regulatory Dashboard: https://www.austrianpharmaservices.com/en/regulatory-dashboard/ ## Contact For consulting requests, audits or inspection support, please contact us at office@austrianpharmaservices.com. We typically respond within 1–2 business days. --- Last updated: 2026-05-24 Source: https://www.austrianpharmaservices.com/llms-full/