Assisting Medical Technology Companies Since 2004
Yakar Engineering is a leading consulting firm, providing strategic and technical guidance to medical device and pharmaceutical companies around the globe, designing and developing innovative solutions in a wide range of medical disciplines.
Established in 2004, Yakar Engineering is driven by a hands-on approach and professional integrity, delivering premium regulatory, quality and clinical management services to our clients.
The firm is comprised of a team of experts, eminent engineers and pharmacists, holding advance degrees from prestigious academic institutions in Israel and North America, who gained numerous years of experience in the fields of engineering, regulatory, clinical and quality affairs in the medical device and the pharmaceutical sector.
Yakar Engineering provides highly individualized and comprehensive integrated solutions, diligently establishing and executing critical product design milestones, meeting all relevant global requirements, standards & directives, in an efficient and cost-effective manner.
At Yakar Engineering, we possess a wide range of contacts with senior opinion leader clinicians across a wide range of medical areas, as well as personal contacts within global regulatory agencies, making us ideally positioned to provide practical and definitive expert input, fully meeting the highest standards of quality.
Our comprehensive services and extensive experience ensure successful navigation of med-tech and bio-tech projects throughout the entire life-cycle process.
Yakar Engineering consulting expertise is built upon an in-depth knowledge of the medical device design and production life cycle.
A multi-disciplinary team of highly experienced Engineers, eminent experts in Medical Device, gained over 30 years of extensive experience in Engineering, Regulatory Affairs, Quality Assurance, Design & Development and V&V, at leading Medical Device companies in Israel, US and UK, in a wide range of medical disciplines.
Our team of experts has developed a reputation for combining high-level strategic expertise with flawless execution, exacting standards of excellence, availability and exceptional services, providing highly individualized and comprehensive medical device professional services, in D&D Project Management, painstakingly establishing and executing critical product design milestones (e.g. Definition, Research, Feasibility Study & PoC, V&V, Prototyping, etc.), fully meeting most stringent requirements, standards, directives and acts, in the most efficient and cost-effective manner, throughout the medical device life-cycle process.
Yakar Engineering offers a wide range of tailored-made services to support the pharmaceutical industries.
Our pharmaceutics experts combine business acumen, medical and pharmaceutical domain expertise, and operating experience to provide pharmaceutical companies with an unparalleled support to plan and manage their pharmaceutical product development programs and regulatory requirements, in terms of comprehensive facilitation, from the early pre-IND/pre-CTA/pre-IDE stage of pharmaceutical development through to marketing applications.
Yakar Engineering has gained extensive experience compiling numerous regulatory documents across a wide spectrum of therapeutic disciplines and phases of development. Our team has authored dozens of clinical study reports (CSRs), Investigator Brochures, Clinical Protocols and Investigational New Drug (IND) applications.
In particular, Yakar Engineering has gained experience establishing the clinical components of marketing applications such as Biologics License Applications (BLAs), New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs).
Yakar Engineering brand has been a pioneer in providing pharmaceutical companies with a premium regulatory, quality and clinical management services, in the most efficient and cost-effective manner.
- Regulatory Strategy & Planning
- FDA Submissions (e.g 510(k), De Novo, PMA, 513(g) requests, HUD, HDE, IDEs, etc.)
- Pre-Meeting Packages, INDs / CTAs / IDEs and post-filing submissions, BLA / NDA / NDS / MAA filings
- Advise on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions
- Support for Pricing and Reimbursement
- New Drug and Medical Device Technical File/ Dossier Compilation, Submission and Maintenance
- Coordination of EU Notified Body audits
- Global regulatory preparation & submission
- Pharmaceutical Dossier Preparation
- Global Product Registration
- Israel Registration Holder for Device and IVD Companies
- Establishment of QMS/QSR Processes and Procedures
- Facilitation of Medical Device Single Audit Program (MDSAP) Compliance
- Risk Analysis & Management
- Global Supplier Assessment & Management
- Standards, Directives & Acts Compliance (e.g. ISO 10993, ISO 11135, ICH Q10, ISO 13485, etc.)
- EU Environmental Directives (i.e.: RoHS, REACH, WEEE, etc.)
- Validation & Usability Studies
- Design Change Management / Configuration Control Management
- Transfer from Design to Production (e.g. PRR, FAI, etc.)
- Compliance with good pharmacovigilance practices
- HIPAA & GDPR Compliance Services
- Pre-Clinical and Clinical Trial Planning
- Clinical Study Protocol Development
- Identifying and Evaluating Study Locations
- Clinical Investigation Management in compliance with EN ISO 14155
- Compilation and Submission of IRB Application
- Site Management and Outsourced Site Monitoring
- Clinical Research Organization (CRO) Assessment & Selection
- CRO Oversight
- Data Management & Bio-statistics
- Development of Clinical Evaluation Reports (CER)
- Post Market Clinical Follow-Up (PMCF) Coordination
- Trial Master File (TMF) Compilation
Extensive experience in facilitating MDSAP compliance for Med-Tech companies in a wide range of medical disciplines, characterized with highly individualized services, in an efficient and cost-effective manner, leveraging years of experience in each MDSAP regulatory market (i.e. US, Canada, Brazil, Australia and Japan)
Securing dozens of MDD/MDR regulatory certificates for Med-Tech companies across EMEA, based on robust platform of professional contacts with leading EU Notified Bodies (e.g. MDC Medical, BSI, MedCert, Intertek, etc.) and proven extensive experience in multiple medical disciplines across the European Union.
Providing comprehensive regulatory services, including local representation as an Israel Registration Holder (IRH) with the Israeli Ministry of Health, as well as facilitating distribution in the region for overseas medical device manufacturers.
High level medical device and pharma compliance & registration services in China, from market strategy through dossier submission, reinforced by highly experienced China-based strategic partner.
Russian Federation & CIS
Assisting foreign manufacturers to get through the Russian complex mandatory requirements for time-critical approvals, leveraging access to key institutions regulating the Russian market, notably, the Ministry of Healthcare of the Russian Federation (MINZDRAV), Federal Service for Surveillance in Healthcare (Roszdravnadzor) for issues related to medical device, drug safety, pharmacovigilance and distribution.
Zion Nigel Yakar
Zion Nigel Yakar has provided expert consultancy services relating to global regulatory compliance for over 25 years, mainly in Israel, UK and US.
Mr. Yakar is also responsible for management oversight of all consulting projects in Israel, US and UK, in a wide range of medical disciplines.
Mr. Yakar’s strengths lie in his strategic approach of combining high-level strategic expertise with flawless execution, operational excellence and business value creation.
Mr. Yakar holds a B.Sc. in Mechanical Engineering and a M.Sc. in Biomedical Engineering, both from the Technion Institute of Technology in Israel.
Moshe J. Cohen
Senior Project Manager
Moshe holds the position of Senior Project Manager at Yakar Engineering, with 5 years of experience in the hi-tech and medical device industry.
Mr. Cohen has served as Regulatory & Quality Manager for numerous companies in a wide variety of medical device disciplines.
In this capacity, Mr. Cohen has assisted these companies to comply with all relevant quality and regulatory standards towards international regulatory certification.
Additionally, Mr. Cohen leverages his background as an engineer to facilitate compliance with design control standards and requirements, as well as interfacing with outsourced design companies towards product design and development.
Mr. Cohen holds B.Sc. and M.Sc. degrees in Electrical Engineering from The Polytechnic Institute of New York University, as well as an MBA degree from the Technion Institute of Technology in Israel.
Director of Pharmaceutics & Clinical Affairs
Ms. German is a Pharma RA & Clinical Research Expert with 12 years of extensive experience in the pharmaceutical industry.
Ms. German held the position of a senior pharmacist at Lot 2 Pharmacy, a leading pharmaceutical company, operates in the Russian Federation, in a wide range of pharmaceutical disciplines, followed by heading the pharmaceutical discipline at Yakar Engineering since January 2019.
As an eminent Pharmaceutical RA & Clinical Research Specialist, Ms. German is characterized with academic excellence and hands-on experience, expert in providing pharmaceutical startup and incubator portfolio companies with a complete knowledge transfer beyond traditional regulatory and clinical research consulting, as well as support for other pharmaceutical regulatory affair and clinical research needs, and assisting in streamlining new drug development, such as product safety, engineering compliance, and Quality Management Systems implementation.
Ms. German holds a B.Sc. in Pharmacy, from the Saint Petersburg State Chemical Pharmaceutical Academy in the Russian Federation, as well as a certified Medical Laboratory Technician, from the Medical College №3, Saint Petersburg, in the Russian Federation.
Yakar Engineering maintains numerous strategic partnerships around the globe with leading service providers, enhancing our ability to provide comprehensive professional services to our clients.
Yakar Engineering maintains a strategic partnership with Cisema, one of the world’s leading Chinese regulatory consultants, in terms of facilitating the compliance process through its direct communication channels with the NMPA. This collaboration enhances Yakar Engineering’s ability to provide high level Chinese NMPA compliance services to its clients in a seamless and efficient manner.
Cisema is a global leader in regulatory and compliance services for China, with 10 locations and over 100 highly qualified staff members. They are a one-stop service provider, supporting businesses in legally marketing their products in China, as well as conducting clinical trials and monitoring post-registration compliance.
Yakar Engineering is proud to maintain a strategic partnership with Methodsense, a leading FDA consulting firm, in terms of facilitating the regulatory compliance process through its direct communication channels with the FDA.
With many years of experience, MethodSense has provided medical technology companies with consulting services that span the entire product lifecycle and supported by LuminLogic, a robust SaaS application, developed by MethodSense specifically as a document and project management tool for regulated environments.
ArrowFast is a global leader in Medical Device Engineering services, with 220 in-house experts, providing companies with a wide range of engineering solutions, from device planning and development through the entire medical device development cycle.
Yakar Engineering maintains a strategic partnership with MedReg Consulting, one of the world’s leading Russian Federation consultants, in terms of assisting manufacturers with the complex mandatory requirements in Russia for time-critical approvals. They leverage access to key institutions regulating the Russian market, notably, the Ministry of Healthcare of the Russian Federation (MINZDRAV) and the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for issues related to medical devices.