Regulatory and 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?
Your Purpose is Our Purpose
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.
Our Expertise
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How Allucent Can Help
Addressing Your Challenges
Not enough internal regulatory expertise?
Challenged with aligning regulatory requirements and clinical programs?
Engage in fast-paced development, striving to meet milestones?
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
Leslie Devos
President, Regulatory and Drug Development Consulting
- 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
Sugato De
Vice President, Regulatory Strategy, Head of Med Tech
- 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
Marcus Delatte
Vice President, Regulatory Strategy
- 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.
Regulatory Guidance and Drug Development Consulting
Navigating the complex regulatory landscape is demanding. At Allucent, we’ve mapped the trail and brought our team of experts to get you to the successful endpoint. We collaborate with your team to discover solutions that meet regulatory requirements. With decades of combined expertise and a solid reputation, we will help you reach your destination.
Clinical Strategy
With the aim of expediting the path to approval, our specialists provide tailored solutions for complex clinical development strategies using their deep understanding of how regulatory strategy and operational procedures interact.
Nonclinical
Our nonclinical experts will help design tailored preclinical development programs that meet regulatory requirements in the most cost-effective and time-efficient manner without compromising the quality of the overall safety assessment.
Chemistry, Manufacturing, and Controls (CMC)
Our comprehensive experience in the industry enables us to ensure that your CMC program has the requisite quality, consistency, and technical validity while conforming to the various global regulatory requirements and quality standards.
Regulatory Affairs
Our expert team helps you navigate the dynamic landscape of ever-changing regulations to ensure that your products and processes meet all relevant regulatory requirements. We have a reputation for excellence in regulatory strategy and submission preparation.
GxP Strategy and Consulting
Our team is highly proficient in providing strategic guidance and advising on complex GxP issues as they arise. We also offer support in investigating and resolving compliance issues in all phases of research and development.
Medical Writing
We offer experienced medical writing expertise that spans the entire process from drafting, reviewing, and updating to full writing of regulatory documents, supporting you with documents that meet all GCP and industry standards.
Publishing and Submissions
Our A-Team has extensive experience in compilation, publishing, and submission in eCTD via the Electronic Submissions Gateway (ESG), encompassing bookmarks, hyperlinks, and overall submission build.
Partner with the A-Team
Allucent, your end-to-end partnership to revolutionize your drug development experience. When you partner with Allucent, you gain immediate access to a coordinated team of experts who are with you at every stage of development. We optimize your drug development strategies, save you time, and ensure your success in the market.
Join us in revolutionizing drug development. Choose Allucent, your partner in success.
Contact Us
Let us partner with your team on bringing new therapies to light.
Get in touch to get started.