Guidelines for the process of cosmetics registration/submission in Israel
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Steps, challenges, and requirements for cosmetics registration in Israel
Part of the regulatory requirements for cosmetics products submission in Israel is listed below:
- After the exact order of activity was determined as required by the Israeli Ministry of Health, a request must be submitted for a license of a new cosmetic product
- Obtain a general license for cosmetic products
- Obtain a license for marketing a new cosmetic product or renew the licenses of a pre-marketed cosmetics product in another country
- The text and graphics for the label and package of the cosmetics products should be arranged and submitted for printing. In the case the products are intended for domestic use, the labeling and instructions for use must be provided in English, Hebrew and Arabic. In the case the product is intended for professional use only within health facilities, the labeling and instructions for use may only be in English.
- Determine what kind of laboratory tests are required and complete the relevant tests by certified laboratories
- Obtain a certificate of free sale for exporting the cosmetic product
- Obtain a BSE certificate if required by the products
- Side effects must be continuously reported
- Maintain the cosmetics licenses and keep track of the process
- Update the Israeli Ministry of Health of any changes of the licenses or a licensed product
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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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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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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.
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.
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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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.
Bio-Chem has been advising biomedical companies for more than 15 years.
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