ADRES positions itself as one of the leading biotech consulting firms, offering a wide range of services to help life sciences companies transform their ideas into reality.
-- ADRES supports life sciences startups as they move through the complex journey of product development, regulatory compliance, and global market entry. As a boutique biotech consulting firm, the company brings deep expertise in regulatory affairs, quality assurance, and CMC strategy. Its mission is to help teams accelerate timelines, avoid costly missteps, and make confident, well-informed decisions at every stage.
Innovation is essential, but it’s not enough on its own. Success in biotech and MedTech also requires a clear regulatory roadmap, the discipline to prioritize, and strong execution. That’s where ADRES comes in. It serves as a hands-on partner from early concept to final submission.
Laying the Groundwork in the Early Stages
ADRES often starts working with academic teams, incubators, and early-stage companies during tech transfer or the initial formation phase. The company’s core focus is to evaluate development potential and build a regulatory strategy that fits both the scientific vision and the business model.
As these startups progress into R&D and preclinical development, ADRES helps them put a long-term plan in place by identifying what’s critical now and what can be delayed, so they stay focused and make smart use of their resources.
Some of the company’s key services at this stage include:
- IND, IMPD, and CTA preparation
- CMC documentation and planning
- Regulatory-aligned preclinical strategy
Supporting Clinical and Global Development
Once clinical development is underway, ADRES remains closely involved. Its experts provide strategic and operational support for clinical trial planning and ongoing regulatory responsibilities. Some of the most valuable services include:
- Engagement with FDA, EMA, and other global regulators
- Inspection readiness planning and mock audits
- GCP, GMP, and GLP compliance support
- Regulatory submission drafting and correspondence
Through its European subsidiary, ADRES EU B.V., it also offers formal EU representation. This opens access to SME incentives and simplifies the regulatory process for non-EU companies working in Europe.
Expertise in Medical Devices and Combination Products
For device innovators, ADRES provides full lifecycle support. From regulatory strategy to CE Marking and FDA clearance, it’s able to guide teams through each step of development. Services include:
- Strategy for 510(k), PMA, De Novo, and MDR submissions
- ISO 13485 QMS implementation
- Guidance on risk management, usability, and design controls
Why Clients Work with ADRES
What sets ADRES apart is not just its technical know-how; it’s how the company works. Clients turn to ADRES for:
- Broad expertise that spans regulatory, clinical, and quality areas
- Smart prioritization to avoid overextending early on
- Reliable execution that turns strategy into results
- Flexible support designed to scale with the project
As founder, Rivka Zaibel, says: “We don’t just advise. We implement. From early feasibility through to post-clinical submission, we act as a true partner.”
Ready to Support MedTech & Biotech Startups
Any MedTech or Biotech start-ups that are preparing for regulatory submission, planning CE Marking, or looking to validate their early development strategy, can get immediate help from ADRES. The company will work with startups to set the right direction and keep them on track throughout the process.
Visit adres.bio to learn more.
About ADRES
ADRES serves clients worldwide, including the United States, Europe, Brazil, India, and China. We operate at the intersection of innovation and regulation, helping companies navigate complex systems and deliver results with confidence.
Contact Info:
Name: Roy Zaibel, Co-CEO
Email: Send Email
Organization: ADRES
Website: https://adres.bio/
Release ID: 89161974
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