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

With over

former regulators
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different regulatory agencies
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annual regulatory submissions
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Plus, a track record of

successful marketing applications
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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.


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 today to experience the difference.

Not enough internal regulatory expertise?

Expertise and Experience

  • With 14 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.
  • We can enhance your health authority meetings with key expertise from former FDA and industry professionals
  • We excel in complex scenarios like fast-track and breakthrough designation, 505(b)(2), and rolling marketing applications.
  • Our GxP compliance experts can save you from expensive downstream remediation activities when deployed early in the development process
  • We have a global footprint and offer support for submissions across the US, Canada, UK, and the EU.
  • We have extensive experience in oncology, CNS, cell and gene therapy, and drug-device combinations.
hand holding compass

Challenged with aligning regulatory requirements and clinical programs?

Aligned Regulatory and Clinical Plans

  • Our experts create optimized drug development plans, saving you time and money.
  • We’ll design innovative clinical trials that prioritize the patient while ensuring timely regulatory approvals
  • We have a broad range of expertise that can navigate the safety, quality, and efficacy pathways during development and registration.
  • Your success is our success – we’re invested as if it’s our own project.
abstract depiction of speed lines

Engaged in a fast-paced development, striving to meet milestones?

Tailored Solutions with Agility and Versatility

  • We’re big enough to offer comprehensive services, yet small enough to provide personalized attention, and nimble enough to quickly adapt plans when needed
  • Our agility ensures quick, smart decision-making tailored to your changing needs.
  • We prioritize. fully understanding your specific needs, so that we can deploy rapidly and seamlessly engage with your team, ensuring a true partnership.
  • Our commitment to your success means we roll up our sleeves and work alongside you.