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Contact Details

Phone number: +972-72-233-7710
Address: 49 Ben-Zion Boulevard, Rehovot 7646203, Israel

Opening Hours

Sunday to Thursday: 9:00 a.m. to 5:30 p.m.
Closed Friday, Saturday, holiday eve and holidays

Our services

Our Industries

Our consulting services

Research and development

Consulting in a variety of areas, including design, research laboratories and clean rooms, development technologies, investor business presentations, regulatory strategies, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC and professional training.

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Design and engineering

Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation, with a combination of theoretical knowledge, practical experience, and in-depth understanding of biomed regulations and in accordance with GxP principles.

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Manufacture and packaging

Consulting on manufacturing plant design, manufacturing process development and engineering, selecting the most appropriate technology, process scale-up, technology transfer, GMP, process improvement, yield optimization and improvement, employee training, validation of equipment, systems, and production and cleaning processes.

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GxP, quality and validation

Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, coordinates adoption of GxP principles, ISO 13485, quality assurance and preparation for global regulatory audits while conducting risk analysis and evaluation, and verification and validation of equipment, systems, software, test methods, manufacturing and cleaning processes, until  a successful audit outcome is obtained.

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Regulation and registration

Regulatory consulting and drug registration,  medical devices, CE mark, dietary/nutritional supplements and cosmetics in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner, in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies, until approval  (marketing authorization) is received.

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Software and systems

Digital healthcare consulting, software development and medical applications in accordance with US  FDA 21 CFR part 11 / EU Annex 11 / US HIPAA / EU GDPR requirements, ISO 13485/ISO 27001/ISO 27799, CE marking, risk assessment, verification and validation of software and control systems until marketing authorization (approval) is obtained.

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