InsideReg is a specialist regulatory affairs consultancy, with full-service capabilities, founded in 2018 by ex-MHRA Assessor and CHMP Expert, Dr Laura Millichamp. InsideReg offers regulatory affairs advice and support throughout the development of medicinal products from proof of concept to Marketing Authorisation and commercialisation. All treatment modalities are supported, including biologicals, ATMPs, small molecule, microbiome and radiopharmaceuticals; and all indications, including oncology, neurodegenerative disorders, pain, cardiovascular, rare and paediatric indications.
The Consulting team comprises highly experienced Clinical, Non-Clinical, CMC and Regulatory professionals, all of whom bring tens of years’ experience to the team, and many are ex-Regulatory Authority Assessors. InsideReg focuses on delivering agile, innovative, and solution-oriented support, ensuring that regulatory strategies align with broader business goals and adapting its services to meet the evolving needs of clients. Whether working with startups, mid-sized companies, or large pharmaceutical firms, the consultancy offers scalable solutions that align with each client’s stage of development and regulatory maturity. A summary of some of the key services provided is outlined below.
Core Services
- Early Regulatory Strategy
The regulatory roadmap starts with a landscape analysis of the current market and regulatory expectations, and a gap analysis of the non-clinical data generated to date, detailing any additional studies that may be needed. A conceptual clinical development plan is then developed, considering future commercial product positioning, highlighting opportunities for differentiation from competitors.
A robust and clear regulatory roadmap is then developed, with clearly defined data requirements, optimised to ensure the most expeditious path to market is selected. Recent case studies include repositioning a product from 505(b)(1) to 505(b)(2) pathway to leverage published data, reduce clinical trial burden and shorten time to market from approximately 10 years, to approximately 4 years.
- Clinical Trial Applications
Approximately 70% of InsideReg clients are in Phase 1 or 2 of development. InsideReg clinical experts include specialist Phase 1 and Phase 2 clinical study managers who lead the CRO relationship from first RfP to trial close out, working seamlessly with both the Sponsor and the InsideReg regulatory team. The regulatory team generate all the documentation required (e.g. clinical study protocol authoring, IND/IMPD and IB) for a successful CTA, checking all the documents, to ensure a high-quality submission. Any potential questions are identified in advance so that the short timelines for responses (e.g. 2 days in Canada, 12 days in EU) can be met with ease. Recent case studies include CTA preparation and submission of CTAs in the EU, UK, Canada and Switzerland, through the appropriate Agency portals (CTIS, ESGNextGen and IRAS) for a global clinical trial.
- Scientific Advice
InsideReg Expert teams frequently support Regulatory Authority meetings (e.g. EOP2, Type C, Pre-IND) with EU Authorities and FDA on a range of topics and indications. With a deep knowledge of the current regulatory landscape and Authority expectations, a clear direction and strategy is set from the outset, precisely positioning the data to maximise the chances of agreement. Full support is provided with briefing book authoring and meeting preparation, identifying possible areas for discussion focus, assigning team roles and responsibility and preparing presentation slides. Rehearsals ensure clear messaging and presentation of a highly professional image to the Regulatory Authorities.
- Orphan Drug Designation
InsideReg regulatory experts have extensive experience with ODDs, having supported over 250 ODD applications in both the EU and US. Once a good probability of success based on clear prevalence and a robust data set has been identified through an initial feasibility assessment, an ODD is prepared and submitted. InsideReg’s EU presence enables them to hold the ODD on behalf of non-EU clients.
- Marketing Authorisation and Lifecycle maintenance
InsideReg Regulatory Experts have in-depth experience of the available submission pathways and are ideally placed to advise on the best strategy for each product, considering submission pathways such as 505(b)(1) or (2) in the US, Centralised or Decentralised procedures in the EU, EU Member State preferences and the current regulatory landscape in each market.
In house developed checklists, trackers and project plans are finalised to manage the process smoothly from start to finish. InsideReg Expert teams identify any potential Major Objections and authority questions in advance and develop risk mitigation plans if needed. This precision-driven approach results in a high-quality dossier, instilling confidence in the Assessing team and maximising the chances of success.
Following approval, InsideReg dedicated lifecycle maintenance team prepare and submit variations on behalf of clients to support timely and accurate maintenance of INDs and product licenses.
Why Choose InsideReg?
- Proven Track Record: Over two decades of successful regulatory support.
- Tailored Solutions: Services customised to each client’s needs and goals.
- Expert Team: Professionals with both industry and regulatory authority experience.
- Agile and Innovative: Emphasis on flexible, forward-thinking approaches.
- End-to-End Support: Guidance from early development through to post-launch.
Contact
InsideReg
Rue du Château 4
1350Orbe
Switzerland
+41 21 802 17 18
