Leslie DeVos
President,
Regulatory & Drug Development Consulting
REGULATORY & DRUG DEVELOPMENT CONSULTING
Are you facing challenges in navigating the regulatory complexities of drug development?
Are you looking for a partner who can seamlessly integrate with your team and deliver innovative solutions that drive your key milestones to success?
We understand the challenges faced by our clients and offer a distinct and tailored approach to regulatory and drug development consulting that sets us apart.
Regulatory Submissions and Experience
With
17
former regulators
From
6
regulatory agencies
And
825+
annual regulatory submissions
Plus, a track record of
61
successful marketing applications
REGULATORY & DRUG DEVELOPMENT CONSULTING
From early drug development through submission & marketing approval to post registration, we bring our passion for innovation, unparalleled expertise and a partnership approach.
We are Allucent. Our focus is on you.
HOW ALLUCENT CAN HELP
Addressing Your Challenges
NOT ENOUGH INTERNAL REGULATORY EXPERTISE?
With 15 former global regulators, including those from the FDA, EMA, and other authorities, our team boasts in-depth knowledge of all regulatory requirements and processes allowing us to optimize your regulatory pathway to maximize the chances for first-time approval.
CHALLENGED WITH ALIGNING REGULATORY REQUIREMENTS AND CLINICAL PROGRAMS?
Our experts create optimized drug development plans, saving you time and money.
ENGAGED IN FAST-PACED DEVELOPMENT, STRIVING TO MEET MILESTONES?
We’re big enough to offer comprehensive services, yet small enough to provide personalized attention, and nimble enough to quickly adapt plans when needed.
Meet Some of Our Experts
We are here to collaborate with you and be your trusted partner in navigating the regulatory complexities of drug development.
- 38+ years of healthcare and industry experience with 17 years leading global regulatory and compliance business units
- Comprehensive knowledge of global regulatory strategies and marketing authorization submissions
- Extensive experience and focus in biotech and novel product development
Sugato De
VP,
Regulatory Strategy,
Head of Med Tech
- Previous Branch Chief and Senior Policy Advisor with FDA’s Center for Devices and Radiological Health
- Expertise in regulatory and clinical strategy with deep experience in combination products, medical devices, digital health, and companion diagnostics
Marcus Delatte, PhD
VP,
Regulatory Strategy
- 12 years at FDA as Senior Toxicology/Pharmacology Reviewer
- Proven expertise in translating nonclinical data to inform clinical program design
- Expert in developing regulatory pathways, including IND and NDA applications, and expedited programs
Merribeth Adams
Sr. VP,
Regulatory and Drug Development
- 40+ years of experience in clinical research and regulatory/governmental affairs
- Highly skilled in regulatory strategy and drug/product development on a global scale
- Deep knowledge of medical device, pharmaceutical, and biologics development
- Decades of interactions have established our reputation with regulatory agencies and strengthened our knowledge of the most efficient ways to help you reach successful outcomes.
- Our A-Team experts round out our clinical support with services that position your therapy for IND, IMP, or equivalent status, and product development guidance for marketing approval and beyond.
- Our regulatory and product development experience runs deep in the pharmaceutical, medical device, and biotechnology industries, ensuring we are an asset to your team with any kind of therapeutic innovation.
EXPERIENCE THE TRANSFORMATIVE POWER OF OUR EXPERTISE
Partner with Allucent to unlock the future of drug development and propel your success.
