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About Us
Pioneering Pathways for Orphan Drugs
Our Mission
To accelerate the development and approval of innovative therapies and technologies by delivering expert regulatory and development support to life sciences companies worldwide.
Our Vision
To be the leading partner for global health innovators—trusted for our regulatory expertise, strategic guidance, and commitment to bringing impactful products to patients everywhere.
Our Core Services at a Glance
Regulatory Affairs Consulting: Expert navigation through the regulatory landscape for orphan drugs, ensuring compliance and strategic submission planning.
Strategic Development: Tailored support in drug development, from preclinical to clinical strategy, specifically designed for orphan drug candidates.
Market Access and Reimbursement Strategy: Comprehensive planning for the unique market access challenges of orphan drugs, focusing on HEOR and reimbursement strategies.
Due Diligence: Rigorous evaluation of potential investments, partnerships, or acquisitions in the orphan drug space, ensuring our clients make informed decisions backed by exhaustive research.
Drug Development Strategies: Designing and implementing comprehensive drug development plans that address both scientific and regulatory requirements, maximizing the potential for success.
Our Story
Cleracs Consulting is a global regulatory and development consulting firm serving pharmaceutical, biotech, and medtech companies across all disease areas and product types. We specialize in regulatory strategy, clinical and non-clinical development support, and market access planning—guiding our clients from early-stage innovation to successful market entry.
Our expertise spans therapeutic products, medical devices, and digital health technologies. Whether you're seeking support with IND, NDA, or CE marking, or navigating complex global regulatory landscapes, our team provides tailored solutions built on deep industry knowledge and regulatory insight. In addition to our core services, we offer strategic support in fundraising and licensing to help clients advance their development programs and unlock commercial opportunities.
Our Team
At Cleracs Consulting, excellence in innovation and expertise defines us. Our team's diverse skillsets and extensive experiences form the cornerstone of our ability to deliver. It's time to meet them.
Why Choose Us
Unrivaled Expertise, Tailored Solutions
At Cleracs Consulting, excellence in innovation and expertise defines us.
Our team's diverse skill set and extensive experience form the cornerstone of our ability to deliver bespoke, comprehensive solutions that precisely align with the distinct needs of each client.
Central to our ethos is a deep-rooted commitment to advancing healthcare innovations.
We recognize the complexities and challenges inherent in the pharmaceutical development lifecycle—from conception to market. Our strategic approach is thus designed to craft custom solutions that not only fulfill but surpass our clients' expectations, with a keen focus on cost-efficiency and meticulous precision.
Opting for Cleracs signifies choosing a partner wholly dedicated to your project's success. We blend unparalleled knowledge with tailored service to navigate the complex process of bringing pharmaceutical innovations to fruition.
At Cleracs, you secure more than consultancy; you acquire a committed ally in realizing your vision.
Connect With Us
Let's discuss how we can support your journey in drug development.
For inquiries or to explore our services:
Email: info@cleracs.com
Phone: +1 757- 895 - 6776
Take the first step towards transforming your orphan drug development strategy. Contact us today.
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