Welcome to

HengRy Switzerland

Empowering life science companies to navigate regulatory and quality challenges with confidence and ease.

About HengRy

“To deliver strategic, results-driven solutions that are precisely tailored to meet our clients’ unique needs and drive their success”

HengRy was founded to address the increasing need for expert regulatory and quality consulting services in the life sciences industry. Based in Zurich, Switzerland, we offer comprehensive solutions to help companies implement effective quality management systems, ensure regulatory compliance, and navigate market entry requirements.

Alongside our consulting expertise, HengRy provides an innovated AI-powered online platform designed for efficient supplier management. This cutting-edge platform streamlines supplier identification, evaluation, and overall supply chain management, helping business optimize their operations and maintain regulatory standards.

Our dual approach- combining industry-leading consulting services with advanced technology- empowers companies to meet their regulatory challenges while ensuring seamless supplier oversight.

At HengRy, we are committed to excellence, consistently delivering tailored, results-driven solutions that exceed our clients’ expectations.

Hello, we are HengRy!

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Our Services

Regulatory Affairs

Provide a full regulatory lifecycle solution for pharmaceutical and medical device organisations

CH-Rep & PRRC

Manufacturers domiciled outsides Switzerland, hook up with us for a complete range of regulatory compliance service

QMS

Develop or refine a QMS to enhance organizational performance and establish a strong foundation for sustainable development

Sourcing

Qualify the appropriate suppliers or distributors and render a full range of contractual, regulatory and quality support

In July 2024 the MDCG has requested the EMA to review whether SARS-CoV-2 IVDs classification remains appropriate.

Essential drug delivery outputs are critical to ensure the reliable and accurate functioning of the drug delivery system

The AI Act introduces new regulatory obligations for medical device manufacturers, particularly those utilizing AI in high-risk applications.

Flexible approach for the clinical evaluation and regulatory approval of orphan medical devices under the EU MDR

Hear from companies just like yours

Le Dr. Yu de la société HengRy travaille en tant que PRRC pour notre société Labgene Scientific SA, et nous offre une aide considérable en matière de gestion de la qualité dans le but de nous permettre d’agir comme mandataire suisse (CH-REP) pour plusieurs de nos fournisseurs basés hors de Suisse, ainsi que de nous mettre en accord avec la nouvelle réglementation IVD-R. Sa grande expérience en matière de gestion de la qualité, sa méticulosité et sa disponibilité sont très largement appréciées.

Optimally navigated and advised us through the various phases of the transition of regulations for medical devices and in vitro diagnostics. Supported collaboration with contractors in a highly professional manner. Highly appreciated the pleasant cooperation!

Very professional and experienced in dealing with regulations, no lengthy questions, straight to the point. Compared to service providers we have worked with in the past, working with HengRy was the smoothest and most efficient.

Dr. Yu from HengRy works as a PRRC for our company Labgene Scientific SA, and provides us with considerable assistance in quality management with the aim of enabling us to act as a Swiss agent (CH-REP) for several of our suppliers based outside Switzerland, as well as to comply with the new IVD-R regulations. Her extensive experience in quality management, her meticulousness and her availability are widely appreciated.

very responsible, attentive and prompt in collaboration. Willing to put up with all the thoughtlessness of the manufacturer and actively coordinate and cope with difficulties.

Agencies

Notified Body, European national authority, Swissmedic and Chinese national authority (NMPA)

Manufacturers

Global manufactures seeking market opportunities in mainland China and Europe

Distributors

Importers and different tiers of distributors seeking distribution opportunities

Maybe you?

Searching training, regulatory and quality support or distribution service