Contact us2021-05-10T18:39:34+00:00

Leave us a message

Contact us

Our industries

Contact form:

















    Contact Details

    Address: Prof. Hillel ve-Khanan Oppenheimer St 2, P.O. 7670102

    Park Ha’Mada, Rehovot 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.

    read more

    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.

    read more

    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.

    read more

    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.

    read more

    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.

    read more

    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.

    read more

    You are invited to contact us

      צור קשר