Accelerating early phase development in the UK and Germany

Recent changes in the regulatory environment post-pandemic and the introduction of EU-CTR 536/2014 are making the UK and Germany more attractive to biotech drug developers. In this video, Parexel experts provide an update on recent early-phase regulatory timelines in the UK and Germany, resulting in trial efficiencies and accelerated approvals for biopharmaceutical companies.

Also, our thought leaders answer your questions about recent changes with the MHRA and EU-CTR process, approval timelines, and the government’s efforts to make these key regions more attractive for conducting clinical trials.

Parexel Biotech can connect every step of development with you. Our Early Phase services combine clinical pharmacology and regulatory expertise to help you move swiftly and efficiently to the proof of concept milestone. Learn more about our clinical units and integrated Early Phase expertise.

Return to Insights Center

Related Insights

Blog

Making cell and gene therapy more accessible in the treatment of solid tumors

Jun 4, 2024

Blog

Best practices for maximizing early-phase trial efficiency to accelerate regulatory timelines

Apr 4, 2024

Blog

Key implications for nonclinical development: FDA guidance on human gene therapy products incorporating human genome editing

Jul 1, 2024

Article

Five strategies for meeting the requirements of Project Optimus and improving the chances of approval

Nov 10, 2022

Podcast

RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry

Jun 16, 2022

Article

8 things you need to know about eCTDs in China

Jul 1, 2022

Blog

Preparing for the New Era of Hybrid Regulatory Inspections

Jul 11, 2022

Article

EU Orphan Drug Designation – overcoming regulatory challenges

Jul 20, 2022

Video

Cell & Gene Therapies: A Regulatory Update

Jul 22, 2022

Blog

U.S. drug price reform of 2022: What does the Inflation Reduction Act mean for drug manufacturers?

Aug 17, 2022

Article

Q&A Project Optimus: What you need to know

Oct 11, 2022

Article

Relyvrio Approval: Lessons Learned

Oct 31, 2022