Study Start-Up & Regulatory

Our local experts pave the way through a complex regulatory landscape

Speed matters in clinical research, and our regulatory team will plan for an accelerated regulatory approval strategy to ensure trial’s success. Our staff are local experts in the language, culture and expectations of the countries and regions. This, paired with a broad therapeutic and regulatory experience, allows us to accelerate trial approval process.

We will work in parallel to ensure the first patient in occurs on time. To achieve this, we will identify risks early in the process, and leverage our existing experience with sites to accelerate contracting timelines.

Our regulatory affairs and study start- up services

IMPDs
Strategic Start-up & regulatory plan
Sites selection
Study initiation
Clinical trial applications
Ethics Committees / Institutional Review Board submissions
Competent Authority submissions
Clinical trial agreements
IMP labels
Import and export licenses
EU legal representations
Translations
Patient insurance

Local experts in every study, high retention, and consistent site support ensure smooth submissions and reliable regulatory execution.

100%

Studies covered with local experts

87.94%

Regulatory staff retention rate

One

Point of contact for the site throughout the study

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Our Solutions for Biotechs

We offer end-to-end clinical development solutions tailored to your needs. Whether you’re preparing for first-in-human or managing a global Phase 3 trial, our agile team delivers expertise, insight, and hands-on support at every stage.

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