Naomi Shaco-Ezra Ltd
Naomi Shaco – Ezra Ltd, NSE Regulatory Affairs Services, was established by Magister Naomi Shaco – Ezra in 1998, a pharmacist with BSc and MSc degrees in Pharmacy, with more than 30 years of experience.
The firm is one of the leading companies in Israel for regulatory consulting, and provides a variety of services related to the registration and licensing of pharmaceutical and medical device products.
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About us
The founder and director of the company is Magister Naomi Shaco-Ezra who holds a Bachelor of Science (BSc) with distinction and a Master’s of Science (MSc) with distinction from the School of Pharmacy at the Hebrew University of Jerusalem.
Appointed pharmacist for companies importing medications and medical equipment and for manufacturing plants in Israel.
Chief pharmacist in pharmaceutical manufacturing plants and in pharmaceutical warehouses, responsible pharmacist (QP) in import companies of medicines.
The company provides a range of services in the pharmaceutical regulatory affairs area to multi international companies and to local Israeli companies, and accompanies all the necessary regulatory processes for the quality and the safety of medical preparations. The services are based on vast experience and include consulting and guidance in development and manufacturing stages, registration, labeling, leaflets, health basket, advertising and distribution of pharmaceutical products and more.
Our services
Marketing Authorization Holder
According to Israeli law, a company interested in being a Marketing Authorization Holder (MAH) of preparations in Israel must be incorporated in Israel and must be licensed by the Israeli Ministry of Health. NSE offers the opportunity to manufacturers to act as the MAH of a preparation regardless of the distribution rights granted. The company is responsible for submitting and maintaining the registration file and taking care of the necessary approvals. The service may be permanent or for interim periods. NSE enables manufacturers to receive service including that of registration holder, appointed pharmacist, responsible pharmacist (QP), qualified person for pharmacovigilance (QPPV), all under one roof.
GMP inspection
NSE is authorized to conduct GMP audits on all sites involved in the drug route. Production sites, transport sites, warehouses, inspection and monitoring of GMP and GDP regulations. NSE is engaged in corporate preparedness ahead of GMP audits. The training includes tutorials to the staff as required in the regulations, reviewing the production and marketing systems with emphasis on points of vital importance to ensure the quality and safety of the products. It is also possible to edit and update procedures according to the requirements of the Ministry of Health.
Pharmaceutical consulting and legal opinions
Pharmaceutical consulting is provided by NSE throughout the life of the drug. Advice before starting the registration process, during and after the registration over the years in which the drug is marketed. Consulting and training in development and manufacturing stages. Classification of products. Marketing and advertising. Involvement in legal proceedings, including the High Court. Advice to companies and organizations abroad regarding registration of medicines and medical devices proceeding in Israel.
Medical devices
For registering medical devices, a special process is required in Israel, which is carried out by the Accessories and Medical Devices unit at the Ministry of Health. NSE has experience in the registration process and submits medical devices to the Israeli Ministry of Health for registration, renewal of registration and variation of a registration. This experience includes submission and monitoring of the registration of medical devices made in Israeli as well as imports.
QP services
The Israeli legislation aligned with
the EU legislation on GMP regulations. In light of this, there is a legal requirement in Israel to appoint a responsible pharmacist who will be in charge of the release of medicines into the market, control of deliveries, storage and distribution of the medicines to the market. NSE's extensive experience with international and local pharmaceutical manufacturers provides you with QP services and provides security by an additional check of the batches intended to be marketed. There is the option of permanent outsourcing services or short-term outsourcing services (vacations/maternity leave/sick leave/military reserve duty, etc.), as needed. Naomi Shaco-Ezra Ltd. (NSE) holds a Manufacturer-Importer Authorization (MIA) certificate from the Israeli Ministry of Health.
Appointed pharmacist
The Israeli law grants extensive authority and places great responsibility on the appointed pharmacist, who is responsible for the relationship between pharmaceutical companies and the regulatory authorities.
NSE provides appointed pharmacist services to various companies which include amongst them: registration of new medications - human and veterinary medicines, health basket application requests for health basket inclusion, renewal/variation of a registration, adjustments of packaging, advertising.
Training and lectures
NSE as a leading professional in the Israeli regulation market, collaborates in preparing and delivering lectures and seminars conducted by professional forums or the Israeli Institute of Standards, as well as closely monitoring new updates and developments in these areas. Possible tutorials and lectures in a variety of our areas of expertise. New employee training is provided at companies as well as training on specific subjects: registration, regulations, etc.
Our clients
The firm’s clients include international and Israeli companies.
The world’s leading pharmaceutical companies have engaged our services for extensive periods.
Services can be obtained for a single product or for all of your company’s preparations, as needed and possible.
Over the years, services have been provided to a variety of companies dealing with preparations of all kinds: orphan medicines, original medicines, generics, OTC medicines and GSL.