Services Startup-Centred Regulatory Support

The Regulatory Catalyst

Transparent, value-driven service packages that deliver expert regulatory guidance to startups looking to attract investors while accelerating market entry. With maximum impact, and no hidden costs.

The Regulatory Catalyst - value-driven regulatory packages for startups

DLRC are proven specialists in global product development and regulatory affairs. With offices in the UK, US and EU, our team has guided numerous startups from pre-clinical to market success.

Unlocking the benefits of regulatory clarity for startups

Accelerate value creation

Achieve investor-ready milestones faster by avoiding common regulatory pitfalls. Our proven process gets you to market quicker while building solid compliance foundations.

Budget with confidence

True fixed-price packaging means zero surprises and predictable spending. Plan your regulatory compliance costs with certainty from the start.

Maximise resource efficiency

Strategic regulatory planning eliminates wasteful spending. Our structured approach ensures you invest only in essential steps that drive your business forward.

Leverage world-class expertise

Access over 1,000 years of regulatory experience without the burden of hiring. Get direct support from senior experts who know your industry inside out.

The Regulatory Catalyst

Whatever your objective, challenge, or situation, we can help:

Scope Session
Strategy Workshop
Structure Report
Showcase Pitch Deck
Complete Catalyst Package

Scope Session

Your regulatory orientation

Gain an overview of the regulatory landscape in this expert-led session. Perfect for biotech leaders and experts who want to understand the journey ahead.

This expert-led session includes a comprehensive outline of the regulatory framework, a review of key regulatory considerations, and product classification guidance. We’ll cover available incentives, optimal approval pathways, essential guidelines and considerations for interactions with regulatory authorities. Equip your team with the critical regulatory knowledge needed to navigate compliance requirements and accelerate your path to market.

Strategy Workshop

Your personalised path to market

We explore a regulatory strategy that saves time, cuts costs, and bypasses common pitfalls, explicitly built around key considerations for your product.

This tailored workshop includes a detailed outline of the regulatory framework specific to your innovation, a review of key regulatory considerations, and expert product classification guidance. Our specialists will identify optimal incentives, strategic pathways, and applicable guidelines while demonstrating effective regulator interaction techniques. You’ll learn proven engagement mechanisms and meeting approaches tailored to your situation. The session concludes with a comprehensive summary of recommendations and a collaborative discussion of options, ensuring you leave with a clear strategy for regulatory success.

Structure Report

Your complete regulatory roadmap

From pre-clinical to market approval, we map the regulatory landscape and key milestones to get your product to market. No guesswork, just clarity.

This comprehensive document includes a concise report summary, detailed scope and background information, thorough project context, and a complete product overview. We outline critical licensing considerations, nonclinical requirements, strategic clinical pathways, and specific CMC requirements tailored to your product. Designed as a cornerstone reference, this report is an internal communication tool for aligning teams and a practical guide for implementing your regulatory strategy. Each section is crafted to provide actionable insights, ensuring your startup has a clear, documented path forward.

Showcase Pitch Deck

Your investor-ready regulatory outline

We transform your regulatory strategy into an overview of your regulatory pathway that speaks investors’ language. Show them you’ve got what it takes.

This professionally crafted pitch deck includes a strategic outline of the regulatory framework relevant to your innovation, highlighting key regulatory considerations with clear product classification details. We showcase available incentives, optimal pathways, and applicable guidelines in investor-friendly terms. The presentation covers your approach to regulator interactions, critical licensing considerations, and streamlined overviews of nonclinical requirements, clinical strategy, and CMC specifications. This deck is explicitly designed to strengthen your investor presentations. It communicates regulatory confidence, demonstrates thorough planning, and positions your regulatory strategy as a competitive advantage, giving potential investors the assurance they need to support your vision.

Complete Catalyst Package

Your streamlined regulatory advantage

Startups need regulatory clarity without complexity. While each of our services can be engaged individually to address specific needs in your regulatory journey, our Complete Catalyst Package combines all four services for startups seeking maximum value at a discounted rate.

 

Why many startups choose the complete Catalyst package:

  • Even more cost-effective than purchasing services individually
  • Fixed-price certainty for reliable budgeting and resource allocation
  • Ensure perfect consistency across all regulatory documentation
  • Build investor confidence with a comprehensive regulatory strategy
  • Accelerate your regulatory timeline with our streamlined process
  • Access our senior regulatory experts throughout your entire journey

Ready to catalyse your journey to market?

Find out how The Regulatory Catalyst can help you attract investors and accelerate your market entry.

Contact our regulatory experts today

Case study

Take a look at how we have helped one of our clients.

First-in-Class Orphan Drug Approval Leads to Multi-Billion-Dollar Acquisition

Challenge

A European biotech company needed comprehensive regulatory support for their ground breaking orphan drug targeting a rare viral condition. Without an in-house regulatory department, they required end-to-end expertise from clinical development through market approval.

Solution

DLRC stepped in as a complete virtual regulatory department, providing:

  • Strategic regulatory guidance and program management
  • Leadership for all regulatory agency interactions
  • Expert document preparation and management
  • Full eCTD publishing services

 

Our team delivered critical support across multiple regulatory milestones, including:

  • Scientific Advice meetings
  • Orphan Drug Designation (ODD) maintenance
  • Pediatric Investigation Plan (PIP)
  • Clinical Trial Applications (CTAs)
  • Marketing Authorisation Application (MAA)

 

Despite the complexities of a first-in-class therapy, our team ensured the MAA submission met all deadlines and and followed an accelerated timetable

Outcome

The product was approved in the EU, validating the therapy’s value and DLRC’s regulatory strategy. This approval was a key factor in the Sponsor’s subsequent acquisition in a multi-billion-dollar deal. DLRC continued to support the new sponsor with preparations for the Biologics License Application (BLA).

When the CEO launched a new company, they engaged DLRC to manage all aspects of regulatory affairs for their ongoing development project. This continuous collaboration showcases how strategic regulatory expertise can deliver substantial value throughout the drug development lifecycle, from initial clinical studies to approval and commercial success.

Find out more about DLRC

Explore regulatory services Meet the team Contact our experts

Testimonials

See what our clients have to say about DLRC

Thank you so much for your support and for guiding us through the entire process! Especially the last couple of weeks were so intense and have shown how important a well aligned team is! Great job everyone … You were our compass all the time… you were always spot on when needed; and all the time, you gave us the confidence to get where we wanted to be at the end.

We wanted to extend our thanks for all of your hard work, expertise and thoughtful partnership … You have been instrumental in operationalizing … capabilities we have been building together across people, process, tech, and content. We know that it hasn’t been easy at times because we are building something totally new and consider you a great partner to navigate this with. We are really looking forward to our continued work … Thank you!”

I take this opportunity to thank you for your initiative and agility in leading regulatory response and strategy in unexpected circumstances … Your support is indispensable and highly appreciated.

I would like to thank DLRC for the great leadership of the filing team and the fantastic preparation and chairing of the pre-submission meeting with the team and rapporteurs. It is great to have your experience and expertise on board for this important filing. The team managed to get all possible information from the rapporteurs in a fruitful and professional atmosphere, fostering great communication amongst the attendees.

We’d like to acknowledge DLRC for their hard work and ‘whatever it takes’ mindset during the recent project activities they completed for us, including key protocol amendment submissions made across multiple countries.

As a small biotech company with no facilities in Europe, we needed a strong partner to represent us and to support our global initiatives. The team assigned to our program has provided a broad range of regulatory expertise and operational support, and has been thorough, organized, responsive, and a pleasure to work with. The onboarding of the DLRC team was seamless, and they made efforts to familiarize themselves with our product and program right away so that they could contribute to both strategic planning and execution. I look forward to continuing our partnership as we progress our program.

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