Supporting Your Product Through its Lifecycle
ADRES is a regulatory and quality affairs consulting firm. Ms. Rivka Zaibel founded the company in 2009, and has successfully led the company since inception. Earlier this year, Mr. Roy Zaibel was appointed as CEO, and the ADRES EU offices were opened in Amsterdam, to enable expansion of our consulting services in Europe.
We Provide the Following Services:
Confidently, smartly and effectively leading regulatory processes,
we assist you in obtaining national and international approvals, expediting time to market.
Products considered complex are our specialty.
- Define regulatory strategy for drug development and approval in European, US and international markets.
- Manage interactions with regulatory authorities, balancing client’s strategy and regulatory authorities’ expectations.
- Initiate and perform consultation meetings with regulatory authorities, e.g. scientific advice meetings, pre-IND, etc.
- Compile and submit regulatory documents, e.g. IND, IMPD, BLA, MAA.
- Consult on clinical trial design and interpretation.
- Compilation of clinical study documentation.
- Preclinical study design and interpretation.
- Provide regulatory input to manufacturing and control processes.
- Establish quality management systems.
- Provide ongoing QA support remotely and/or at client’s offices.
- Quality oversight and audits at client’s service providers (CMOs, CROs etc).
- Review and establish quality agreements with service providers.
- Hold mock inspections to prepare for European and FDA pre-approval inspections.
- Prepare quality improvement plans.
- Quality oversight of QC activities as well as review of analytical and bioanalytical method development, protocols and reports.
- Establish quality management system required for sponsor’s managing clinical trials.
- Prepare and review clinical documents (study protocol, ICF, study plans, etc.).
- Ongoing medical QA oversight to ensure sponsor oversight.
- Quality oversight and audits at clinical service providers.
- Review of study trial master file.
- Establish inspection readiness and risk assessment tools for clinical studies.
- Identify and assist in the selection of contract manufacturing organisations (CMOs).
- Establish contract manufacturing projects.
- Assist in establishment of in-house manufacturing operations, with emphasis on GMP compliance of facilities, equipment and personnel.
- Assist in analytical and bioanalytical method development and validation.
- Perform an extensive gap assessment of the various computerised systems, with focus on data integrity capabilities.
- Establishing data integrity document systems, to ensure implementation of data integrity principals.
- Specialising in finding simple and effective solutions, that are tailored to the client’s need, according to the stage of developmentPerform data integrity audits
Coordinate client projects, including the client’s team and external service providers, as well as with the different functions within ADRES.
Who we are: ADRES is a prominent, well-established regulatory and QA consulting company based in Rehovot, Israel. Established in 2009 by Ms. Rivka Zaibel, with the mission of assisting Israeli biopharma companies in drug development processes, the company focuses on effective and lean regulatory and quality management strategies. The ADRES team is comprised of scientists and engineers as well as regulatory and quality experts.
Who we serve: ADRES’ clients range from young start-up companies to commercial phase companies. Our clients operate in a variety of pharmaceutical fields including vaccines, biologicals, cell therapies and ATMPs, botanical drugs, liposomes and medical devices, all in pursuit of treatment for an array of medical conditions. We provide services to clients around the globe including in Israel, the USA, Europe, Brazil, India and China.
Our European subsidiary ADRES EU B.V. is located in Amsterdam, The Netherlands. Holding SME status, ADRES EU includes other small companies, enabling access to a variety of regulatory benefits ( e.g. considerably reduced fees when approaching a scientific advice meeting with the European Medicines Agency – EMA).
ADRES EU also serves as the European Representative during the conduct of clinical trials for pharmaceuticals and medical devices, as well as the European Representative for CE-marked medical devices.
Ms. RIVKA ZAIBEL
Founder and President
Rivka is a key opinion leader in the local and global bio-pharmaceutical industry, in the fields of RA, CMC, and QA
Mr. ROY ZAIBEL
CEO, Data Integrity, QA specialist
Roy side by side with Rivka aiming to enhance ADRES and ADRES EU activities in order to add our clients` success
Mr. RAZ ELIAV
CMC & Regulatory Affairs Director
Ms. INBAL HACMON
Ms. NAVIT SELA
Business Development & HR Manager