Collaborating with regulators is essential to developing robust, forward-thinking strategies that accelerate time to market. A strong strategy integrates scientific innovation, clinical evidence, and regulatory planning to advance therapies through the development chain.
I bring firsthand insights into regulators priorities here in Europe and their decision-making processes.
Development Strategy
Provision of regulatory development plans from FIH to registration. Analysis of Health Authority questions and response strategies. Timing of key interactions or appropriateness of expedited pathways.
Regulatory Writing Services
After working directly with leading agencies such as the EMA, FDA, and MHRA, I can help you to craft documents that regulators understand and want to read.
Regulatory Agency Liaison
EJ Consulting acts as a strategic bridge between the regulatory Agency and the Sponsor by managing official communications, interpreting complex regulations, and facilitating smoother approvals of trials and official applications.
Paediatric Development Plans
In Europe, the Paediatric Plan is expected at Phase 2. Rather than focus on regional requirements, I can help to develop and write a plan that is acceptable to UK, US and EU. I can also help you modify existing plans or craft a “stepwise” PIP.
Clinical Trial Support
EJ Consulting can help you file your CTA applications, and create documentation for Health authority questions and CTA life cycle management.
We can help you navigate compassionate use programs here in the EU.
Small Medium Enterprise Services (EU)
We help smaller pharmaceutical companies qualify for dedicated regulatory guidance, fee reductions for scientific advice, and free translation services.
Request a Detailed Proposal
Submit the inquiry form to facilitate a comprehensive discussion regarding your objectives and to identify precise service alignments.
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