Decades of industry and regulatory authority experience, combined with agile, innovative and solution focused collaborations.

Advising on critical decisions such as CRO selection, animal model, number of animals, study design and duration.

Review of the data generated to date to identify potential risks, and preparation of risk mitigation strategies.

Identification of questions that would benefit from regulatory authority input, and provision of full support through the scientific advice procedure to ensure all challenges are addressed in line with current expectation

Critical analysis of the data generated and advice relating to potential risks and next steps, on both buy and sell perspectives.

Oversight data generation, from CRO selection to final report approval.

Authoring of documentation for regulatory submissions at clinical trial and marketing authorisation stages, carefully positioning all data, identifying potential questions and risk mitigation strategies.

We advise on the more appropriate legal basis (e.g. Article 8.3, 10.1, 10.3 in the EU and equivalent in the UK; 505(b)(1), 505(b)(2) in the USA, TPA Articles in Switzerland) for the authorisation of each product at an early stage, so the route to approval is clear from the outset.

Our experts have supported hundreds of ODD designations. We review the data, estimate the probability of success, and author high quality applications to maximise the probability of success.

Many start-ups are based outside the European Union and are therefore unable to access the ODD, PRIME and SME schemes.

By using InsideReg’s office in Ireland, we hold the designations on your behalf until you are ready to establish a legal entity in the EU.

Our clinical and regulatory experts advise on the correct regulatory pathway: deferral, waiver, PIP submission. Thereafter, we draft or review the application documents, ensuring the data and justifications are well positioned and in line with current regulatory expectations.

We can also publish and submit the PIP on your behalf, liaising with the regulatory authorities until successful completion of the application.

A Marketing Authorisation Application is a complex activity that requires careful planning and preparation far in advance, regardless of whether national, DCP/MRP or centralised procedures are used.

We guide you through each step, ensuring right first-time submissions and a smooth and timely approval.

Our highly experienced regulatory and publishing experts have developed checklists to ensure that everything is present and correct for that right first-time submission. We collate and check all the documents, taking applications smoothly through publication, submission, validation and into the review phase.

We manage all the communications with the regulatory authorities on your behalf, so that you can focus on ongoing activities.

Our specialist lifecycle maintenance team has a combined experience of over 50 years in EU, UK, FDA and Swissmedic submissions.

We advise on reporting category, variation timelines and strategy, ensuring regulatory compliance is maintained, even when timelines are tight.

Review of data generated previously to identify potential risks, and to form the foundation of creative risk mitigation strategies.

Identification of questions that would benefit from regulatory authority input, and provision of full support throughout the scientific advice procedure to ensure all challenges are addressed in line with current regulatory expectations.

Critical analysis of data generated and advice relating to potential risks and next steps, on both buy and sell.

Authoring of documentation for regulatory submissions at clinical trial and marketing authorisation stage, carefully positioning all data, identifying potential questions and risk mitigation strategies.

Authoring and submission of ATC code and INN applications, and submission to WHO.

Technical advice during development and manufacture, advising quickly and clearly to facilitate decision making and progress towards that next clinical trial or registration batch.

QP services supporting QMS design and implementation, audit support, and batch release activities.

A living document outlining the conceptual approach and expected changes based on emerging data and operational constraints.

The CDP is an expansion of the clinical strategy, providing a more granular and detailed approach to the programme, expertly positioned to be credible, and optimised for regulatory acceptance.

Our clinical experts have decades of experience in designing clinical study protocols that are acceptable to regulatory authorities.

A natural follow-on activity from the clinical strategy and CDP development.

Identification of questions that would benefit from regulatory authority input, and provision of full support throughout the scientific advice procedure to ensure all challenges are addressed in line with current expectations.

Critical analysis of data generated and advice relating to potential risks and next steps, on both buy and sell.

Our clinical and regulatory experts advise on the correct regulatory pathway: deferral, waiver, PIP submission. Thereafter, we draft or review the application documents, ensuring the data and justifications are well positioned and in line with current regulatory expectations.

We can also publish and submit the PIP on your behalf, liaising with the regulatory authorities until successful completion of the application.

Authoring of documentation for regulatory submissions at clinical trial and marketing authorisation stage, carefully positioning all data, identifying potential questions and risk mitigation strategies.