International Biotech
Consultation and Execution
Illuminating biotech from therapeutic concept to market. Complete regulatory, QA, and CMC consulting services for pharmaceutical and medical device companies
About us
At the intersection of innovation and regulation
ADRES’ team of consultants guide startups and established companies as they navigate complex medical regulatory environments. From novel medical devices to new biopharma creations and technologies, ADRES has the experience and relationships to help secure regulatory approval in the United States, Europe, Israel, and globally.
ADRES clients operate in multiple fields, in the pursuit of treatments for an array of medical conditions. They include vaccines, biologicals, cell therapies and ATMPs, botanical drugs, liposomes, and medical devices. Our clients are located around the globe, including Israel, USA, Europe, Brazil, India, and China.
ADRES clients operate in multiple fields, in the pursuit of treatments for an array of medical conditions. They include vaccines, biologicals, cell therapies and ATMPs, botanical drugs, liposomes, and medical devices. Our clients are located around the globe, including Israel, 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.
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.
Full Coverage
Service for Every Vertical
Startups
Big Pharma
VC
Academic Institutions
How we help you?
Understanding the five stages of development
Developing pharmaceutical products and medical devices is a complex undertaking. We’ve broken down the process into 5 stages
Early Stage
ADRES’s mission at this stage is to protect companies from delays while staying within budget. We help our clients prioritize and focus on the steps needed to creatively turn their vision into reality.
Pre-clinical
ADRES guides you through the preclinical stage, preparing you for phase 1 clinical trials. We help design preclinical studies to ensure you are set up with relevant safety data, and consider animal welfare, including interacting with global regulatory authorities.
Clinical
As the product moves closer to reality, it’s time to connect all the dots. We help keep everything moving forward, from preclinical studies, non-GMP and GMP materials, working with analytical methods laboratories and CROs, and interacting with global regulatory authorities.
Registration
Towards completion of the clinical stage, it’s time to provide the regulatory authorities with all the data and knowledge accumulated in support of the product approval. ADRES helps you prepare documentation demonstrating the efficacy and safety of the product. We manage interactions with global regulatory agencies, balancing their expectations with your needs and strategy.
Approved for Market
ADRES can work with your existing team, providing agility and expertise as you navigate legal requirements to bring your product to market.
Early Stage
Pre-clinical
Clinical
Registration
Approved for Market
ADRES’s mission at this stage is to protect companies from delays while staying within budget. We help our clients prioritize and focus on the steps needed to creatively turn their vision into reality.
ADRES guides you through the preclinical stage, preparing you for phase 1 clinical trials. We help design preclinical studies to ensure you are set up with relevant safety data, and consider animal welfare, including interacting with global regulatory authorities.
As the product moves closer to reality, it’s time to connect all the dots. We help keep everything moving forward, from preclinical studies, non-GMP and GMP materials, working with analytical methods laboratories and CROs, and interacting with global regulatory authorities.
Towards completion of the clinical stage, it’s time to provide the regulatory authorities with all the data and knowledge accumulated in support of the product approval. ADRES helps you prepare documentation demonstrating the efficacy and safety of the product. We manage interactions with global regulatory agencies, balancing their expectations with your needs and strategy.
ADRES can work with your existing team, providing agility and expertise as you navigate legal requirements to bring your product to market.
Our Team
Personalized, expert service at every step
Rivka Zaibel
President and Founder
Roy Zaibel
Co-CEO
Inbal Hacmon
Co-CEO
Navit Sela
HQ Director
Tamar Oved
QA & CMC Director
Lital Isreali Yagev
Scientific and Regulatory affairs Director
Liron Gibbs Bar
Senior Scientific and regulatory consultant
Inbal Apel
Senior QA Consultant & QMS Specialist
Hadas Arens Arad
Senior QA Consultant
Carmel Dafna
Senior Quality Consultant
Einat Ben Gaon
Office Manager
Tanya Fineman
Client Success Lead & Marketing
Rotem Dumany
Senior QA/RA Consultant
Hadar Rips
Regulatory Consultant
Rivka Zaibel
President and Founder
Roy Zaibel
Co-CEO
Inbal Hacmon
Co-CEO
Navit Sela
HQ Director
Tamar Oved
QA & CMC Director
Lital Isreali Yagev
Scientific and Regulatory affairs Director
Liron Gibbs Bar
Senior Scientific and regulatory consultant
Inbal Apel
Senior QA Consultant & QMS Specialist
Hadas Arens Arad
Senior QA Consultant
Carmel Dafna
Senior Quality Consultant
Einat Ben Gaon
Office Manager
Tanya Fineman
Client Success Lead & Marketing
Rotem Dumany
Senior QA/RA Consultant
Hadar Rips
Regulatory Consultant
Why ADRES?
1
Discovery, Creativity and Wizardry
Our out-of-the-box thinking creates endless breakthrough opportunities. Your obstacles are our challenge.
2
Intelligent and Savvy
Smart, experienced, and professional employees assure that you are in good hands
3
Down to earth and Pragmatic
First, we find the right solution, then we execute. Our team can assimilate into your operations and assure you get things done. Our Partners
They Believed In Us
We delivered
Satisfied Clients
These guys are a customer oriented, dedicated team that most importantly know how to think out of the box within the regulatory environment.”
Oren Hershkovitz, Ph.D
CEO
ADRES regulatory services provide a kind, professional and efficient solution for its clients
Eyal Breitbart, PhD
Senior Vice President Research & Operations VBL Therapeutics
ADRES’ QA and RA team provided guidance and support for the many challenges OPKO faced during product development. ADRES’ team experience and knowledge were proven each time.
Laura Moschcovich
General Manager at OPKO Biologics Ltd.
