What we can do for you

Our Services

Audits & Inspections

Having a former head of an European Inspectorate in our rows, we can assist you with all GxP and medical device audits and inspection issues. Audits of CROs, clinical sites, laboratories (GCLP, GCP, GLP, ISO), pre-inspection and post-inspection services will be performed worldwide. We have experience with most global players in this field, including PIC/S and WHO.

Regulatory Strategy

INSA provides expert advice to define the appropriate regulatory strategy for your drug or medical device development program. We support your regulatory affairs efforts with in-depth knowledge of and experience with European and U.S. regulations to bring your product to market - effectively and efficiently.

Legal & Regulatory Compliance

Our experts provide a broad range of services around compliance, from pure consulting after assessment up to process development. We offer several service packages for data protection (DPO), assist in court cases and develop contracts. In addition, expert opinions (like financial company assessment for stock exchange), support by providing experts (e.g. PRRC) and in depth knowledge of Drug and Medical Device Law is amongst our core businesses.

Clinical Studies

With an extensive track record of excellence in clinical operations, our experts and partners offer your team the full range of consulting services. From clinical study planning, protocol development, recruitment and retention strategies, to medical writing and trial rescue management, INSA will comprehensively support you to ensure the success of your clinical study.

Please note that we have a specialized partner in Georgia ("Austrian Medical Services") and are highly experienced with clinical trials in eastern countries. We can assist with regulatory issues, audits and inspection preparation in this geographical region!

Risk Management

Our team consists of highly-qualified and experienced strategic risk managers. We support clients on a wide array of risk assessment, data security, and safety compliance issues. We provide sustainable and feasible business solutions to manage threats from compliance, technology or operational errors. Integrated risk management systems are key items to tackle complex regulatory requirements, particularly for healthcare products, as well as to control potential uncertainties along the product life-cycle.

Quality Management

Creating sustainable growth by establishing high level quality management systems is one of our core business operations. We provide guidance with strategic development and improvement of business processes.

We implement technical and QM requirements such as ISO/IEC standards, lean management systems and establish systems e.g. according to ISO 14155, 15189, 13485 or for clinical trials. We aim to meet the exceed needs of our customers to get their products efficiently to market.

Get to know us

The CEO

Alexander Hönel

Mag. DDr. Alexander Hönel, MSc, LL.M., MBA

DDr. Hönel was 10 years head of the Inspectorate & Enforcement Department of the Federal Office for Safety in Health Care, Austria, Europe (2004-2014), is currently Co-owner of a Gxp training company (GxP-konkret, since 2019) and CEO for INSA (Inspection & Audit e.U., since 10 years), performing dozens of audits worldwide for mainly GCP, GLP & GMP and acting as Data Protection Officer for pharmaceutical companies.

Educational Background:

Dr. jur. (Law) - University Vienna

Dr. vet. med. (Veterinary Medicine) - University Vienna

Mag. phil. (politics and history) - University Vienna

MSc (Master of Science) - Pharma Management University Krems/Austria

MBA (Master of Business Administration) - Public Health Care, WU Vienna

LL.M (Master of Laws) - Medical Law, University Linz, Austria

Besides he was head of the Ethics Committee of Salzburg for three years.

Previously, he spent several years in Industry, Clinical Liaison Manager and Senior Medical Manager, and at the university as assistant.

In 2014 he founded Quality By Experts, The Inspectors Network, performing Consulting and Training Services as well as Audits in GCP, GMP, GLP, Blood, Tissue and Medical Devices, and Trainings (2014-2020).

During the time leading the Inspectorate, he was always active as inspector, in several areas of expertise like GMP, GLP, GCP, Blood and Tissues, Advanced Therapies, Medical Devices, Hemo- and Tissue Vigilance, Quality Defects and Drug Shortages, Pharmacovigilance, Narcotics (for OECD), Import of Medicines to Austria, Enforcement, doing several hundred inspections in the mentioned fields during these years, main areas Quality Management Systems in hospitals, assessment of Quality Assurance and Management Oversight.

As Head of Enforcement he established the link to police and border police, did speeches at congresses like for the WGEO (Working Group of European Enforcement Officers). In addition, for 10 years he was acting EMA Expert (for PHV and GCP), member in the Medical Devices Group, and PIC/S Executive Committee member, as well as WHO inspector. He is active member of the national Austrian Anti-Doting Agency (NADA).

The team assigned to your specific task will mainly consist of former regulators and inspectors/auditors. The inspector's network is our specific USP.

All the specialists are well known to INSA since many years, have been working together with DDr. Hönel either in projects, during his time in the agency, the EMA or WHO and are located in many different countries, therefore are well aware of the local regulations.

We will link you with former inspectors as needed!

You specify your needs - we make a proposal for the approach!

The Team

Quality, not quantity

They are working with us

Austrian Medical Services LLC

Georgia, Tbilisi, Vake District

Irakli Uchaneishvili st, N 47a, app.11

INSA e.U. links you with former regulators and inspectors. Expertise by Experts.

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