Efficiency & Compliance in the MedTec, BioTec and Pharma Industry
We have been supporting demanding and/or time-critical QM, MDR, FDA, GxP and regulatory compliance projects for 20 years.
We master the complexity of regulatory, normative and GMP requirements and their interactions.
We are team players and are happy to bring our experience and best practices to your projects.
BENEFIT FROM OUR YEARS OF EXPERIENCE, LET US HELP DEVELOP EFFICIENT AND CUSTOMIZED SOLUTIONS FOR:
MEDICAL TECHNOLOGY
Whether start-up, SME or corporation, our team will be happy to accompany you on the most efficient and safest way and over all regulatory and normative stumbling blocks to market success.
BIOTECHNOLOGY
no matter how complex the official regulations relevant to your company are - we will guide you safely through the thicket of regulations.
PHARMA & GMP
Our three main areas of work in pharmacy are: GMP engineering, system qualification, and end-to-end optimization and scaling using a "risk-based approach".
CONSULTING SERVICES
I work with clients, providing exceptional consulting services that are catered specifically to their needs. Take a look below at the services I offer and get in touch to achieve immediate results.
REGULATORY COMPLIANCE
The fastest safe way to market.
#MDR 2017/745, IVDR 2017/746,
FDA's CFRs, EMA, GAMP, Clinical Eval,
MEDDEV
QUALITY MANAGEMENT
On course for growth with (audit) security.
# ISO 13485, 21 CFR 820, MDSAP, PQS, EU-GMP, CSV, PMS/PMPF, CAPA
RISK MANAGEMENT
The risk-based approach to saving time and money in product development, approval, and production
# ISO 14971, ICH Q9, IEC 62366, Usability
RESEARCH & DEVELOPMENT
Accompaniment & support of agile development from requirement engineering to checking technical files.
# GLP, IEC 60601, IEC 62304, IEC 82304, UD/UX, ISO 11073, ISO 15223-1, ISO 17664