Global Regulatory Affairs Consulting

Name: Cleracs Consulting | FDA Orphan Drug Consulting Expects
Address: 529 Main Street, Boston, MA, 02129, US
Telephone: +1 757- 895 - 6776

Grow Your Vision

Braving drug development's challenges is no small feat, but your dedication shines bright! We're here to back you all the way to success let's make waves in healthcare together.

Cleracs is here to add value to our client’s drug development strategies by leveraging the experience of our team in regulatory affairs and clinical research to advance products from the pre-clinical phase to market authorization.

Our Services

Orphan drug / Rare Diseases

Medical Writing: From technical documentation to strategic program evaluation, our team delivers high-quality medical writing services to support your regulatory submissions and engagements.

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Biotech strategy consulting

We specialize in guiding biotech companies through critical milestones, offering expert services in:

Out-Licensing: Maximize asset value with strategic partnerships.
In-Licensing: Identify and secure opportunities that align with your goals.
Fundraising: Raise capital effectively to fuel growth and innovation.

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Medical Devices

Regulatory Strategy Development: We work closely with your team to develop regulatory strategies that align with your product development goals and target markets.

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A Team of Specialists

At Cleracs Consulting, every member of our team brings over 200 combined years of industry, Agency, and Consulting experience in orphan drug and advanced therapy regulations and development.

With an all-Ph.D./MD/MS level staff consisting of clinical experts, senior regulatory strategists, and publishing experts, we have the skillsets to handle any challenge.

Get in Touch

USA

529 MAIN STREET, SUITE 200

CHARLESTOWN, MA O2129

CALL +1 757- 895 - 6776

124 CITY ROAD , LONDON

EC1V 2NX

info@cleracs.com