Navigate regulatory complexity with confidence

Deep expertise and experience guide you through the regulatory process, so you stay compliant and on track.

Streamline your path to approval

Making your way through the complex regulatory landscape can feel daunting — but you don't have to go it alone. That's where we come in. Whether you're launching your first clinical trial or managing a global portfolio, you can count on us. We will help you navigate regulatory nuances with clarity and confidence.

Reach your milestones quickly, efficiently, and compliantly

Tap into our deep regulatory know-how and experience. We’re here to help you design a sound strategy and prepare submissions that are compliant without costly and time-consuming rework. We offer a range of services to support you from discovery to commercialization and beyond. Together, we’ll find the right level of support for your needs.

Regulatory services for every phase of drug development

From strategic consulting for your first in clinic to regulatory submission and post-market approval, you’ll have an experienced global regulatory specialist guiding you every step of the way.

Preclinical: build a strong foundation

We offer the following services during the preclinical stage:

Strategy development

Guidance planning your strategy and regulatory roadmap
Identify gaps early with GxP readiness checks and avoid delays later

Intelligence

Access to our regulatory databases and specialist insights
Identify any applicable expedited programs

Readiness support

Get support authoring and reviewing Module 3 (CMC/IMPD) documentation
Receive early development guidance for investment decisions

Meeting support and filings

We help you prepare with briefing documents, meeting requests, and presentation materials
Participation in FDA formal meetings (e.g. INTERACT, Type D, Type B) and EU scientific advice meetings
Authoring and publishing IND/CTA dossiers in eCTD format
Submission IND through FDA ESG gateway

Clinical: keep trials moving smoothly

We offer the following services during clinical trials (phases 1 to 3):

Ongoing support

IND/CTA amendments and updates
End-of-phase (EOP) and preapproval meeting preparation
CMC updates and change management

Designation program applications

Fast Track, Breakthrough Therapy, Orphan Drug Designation (ODD), etc.
Strategic guidance and document preparation for designation requests

Marketing application review

Full authoring and publishing of marketing applications
Pre-BLA/NDA meeting preparation
Support responses to FDA/EMA queries and CRL

Inspection readiness

Support for preapproval inspections and regulatory audits

Commercial: stay compliant, post-approval and beyond

We offer the following services during pre- and post-commercial scaleup:

Post-approval changes

Support for FDA supplements (e.g. PAS, CBE and annual reports) and EMA variations

Lifecycle management

Continued regulatory strategy and compliance support
Assistance with global submissions and updates

Need support with your next regulatory milestone?

Let's discuss how to best accelerate your path to approval.

Get a custom roadmap

30+

years of experience in FDA and EMA filings

2000+

successful responses since 2020

60+

File INDs up to 60+ days faster

40+

countries supported

5000+

regulatory documents

Find the regulatory documentation you need

Access regulatory documentation

Subscribe to receive change control notifications (CCNs) and product documentation.

View documentation

Get regulatory statements instantly

Find the statements needed for regulatory requirements.

Find regulatory statements

View quality and site certificates

Find our quality policy documentation and site certificates.

Download certificates

Review extractables data

Find extractables and leachables testing data.

View the data

Learn from expert articles and free training courses

Regulatory articles

In depth articles on the regulatory considerations per molecule.

Regulatory courses

Understand the basics of regulatory requirements. Take one of our free training courses.

Ready to accelerate your regulatory approval?

Talk to one of our consultants to get started.

Request a strategy session

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