Services Offered

Protocol review

Targeted assessment of strengths and weaknesses of protocols, from a design, analysis and interpretation perspective;
Predicting likely regulatory issues and developing pre-emptive strategies to solve them quickly.

Specific procedures

Paediatric development including PIP content;
Orphan procedures, including significant benefit;
Overcoming regulatory challenges with decentralised and pragmatic trials.

Authorisation

Developing strategy and content to prepare the authorisation dossier and answer regulatory questions arising from assessment;
Preparation for live interactions;
Mock statistical assessment.

Development team consensus building

Regnitio offers flexible onsite and remote options to work with teams globally, driven by the needs of the customer.

Due diligence and bid evaluation

Regnitio provides an independent voice for medicines developers and their investors when reviewing proposed clinical trial programmes.

Fractional consulting

Regnitio can work with early stage developers and CMO offices who need short-term executive level strategic decision making on trial designs and regulatory strategy.

About our lead consultant

Regnitio's owner and lead consultant is Dr Andrew Thomson. With over 20 years experience as a statistician, including 18 years as a regulator at national and international Agencies, Andrew brings a deep and unique insight into the regulatory system.

During his long career he has experience of:

Reviewing thousands of dossiers for Scientific Advice and Marketing Authorisation, including peer reviewing the assessment reports to help develop a joint position;
Driving harmonised EU strategy across wide areas of methodology for medicines development, including EU guidance generation and published EU position papers across multiple therapuetic areas;
Achieving consensus between regulatory regions in his role as Regulatory Chair of two ICH guidelines - E11A and E6 Annex 2;
Managing and leading a team of Real World Evidence regulatory scientists supporting post-authorisation activities.

This experience provides the solid basis to enable clients to best understand how to maximise their regulatory interactions, minimising the risk of unfavourable outcomes, and facilitating faster authorisation times. In the world of AI, he provides an informed, authentic and independent voice to decision makers.

Click below to see his full CV and his list of publications.