Regulatory Gap Analysis

Whatever your stage of development, understanding of your quality, non-clinical and clinical plans and/or existing data to meet global regulatory expectations is key to driving projects forwards. DLRC can perform a full gap analysis of your programme to provide advice on the risks associated with any identified gaps and how best to address them enabling you to optimise future development.

Regulatory Strategy

The regulatory environment is complex and presents a multitude of options and opportunities to optimise the development of products. DLRC consultants use their extensive understanding of the global regulatory environment for medicines and devices to develop and implement creative and innovative strategies to maximise the long-term success of our client’s products.

Early Regulatory Interactions

Early regulatory interactions can be key in the first stages of developing a product particularly those where new innovations bring new regulatory challenges. Regulators globally have a mission to support innovation in medicines and have a variety of pathways to discuss important aspects of innovation right from the start. DLRC helps our clients to navigate these pathways across multiple territories to optimise the chances of enduring regulatory success.

Examples include:

Innovation Task Force (EMA, Europe)

Set up by the European Medicines Agency, the Innovation Task Force is a forum for early dialogue with EU regulators and provides multi-disciplinary scientific, regulatory and legal input on innovative aspects of drug development. DLRC can help identify those products that would benefit from an ITF meeting and help guide you through the process to a successful conclusion.

INTERACT (FDA, US)

An INitial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting is an informal, non-binding consultation with the Centre for Biologics Evaluation and Research (CBER) at FDA enabling sponsors to obtain preliminary informal advice on innovative products at an early stage of development. DLRC can help identify those products that would benefit from an INTERACT meeting and help guide you through the process to a successful conclusion.

UK Innovation Office (MHRA, GB)

The MHRA Innovation Office supports the development of innovative medicines, devices and manufacturing processes and provides free, confidential expert regulatory advice and guidance to organisations of all backgrounds and sizes based nationally or internationally.  DLRC have a history of successful Innovation Office Interactions that have helped guide our clients in the early stages of developing innovative products.

Advice Meetings

Throughout development, frequent interaction with global regulators enables optimisation of development and maximises the chances of success for medicines. DLRC have extensive expertise in defining the optimal strategy and supporting clients through the process of regulatory advice meetings.

These include

FDA Meetings

FDA offers four types of meetings comprising Type A, Type B, Type B (end of phase (EOP)), and Type C depending on the stage of product development. DLRC can help clients get the most out of these meetings by efficiently navigating them through the preparation and formal procedures, ensuring key issues are effectively addressed.

Scientific Advice

EMA and National Competent Authorities provide scientific advice to medicine developers throughout development, supporting the timely and sound development of high-quality, effective and safe medicines. DLRC can not only help identify key challenges and specific technical questions to be discussed, but also provide relevant insights as to what type of advice would be the most appropriate for your product.

Formal Meetings

EU Centralised Advice

The Scientific Advice Working Party (SAWP) at EMA comprises dozens of experts from a range of disciplines and, together with the CHMP (Committee for Medicinal Products for Human Use), provide advice on all aspects of medicine development.

DLRC has a long record of successful CHMP interactions and can help prepare and manage any and all aspects of scientific meetings, and effectively coordinate all communications with the regulatory authorities.

National Advice (EU/UK)

Scientific advice from EU National Competent Authorities (NCAs) or the Medicines and Healthcare products Regulatory Agency (MHRA) in the case of the UK may also be sought. Advice received in these meetings is applicable to that individual country but can often be a quick and effective way of gaining a range of regulatory views or where there are questions pertaining to clinical trial approvals.  DLRC have extensive experience of local advice interactions across a variety of EU countries and with the MHRA.

Combined HTA/CHMP Advice

Since July 2017, EMA has offered consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA) with the aim of assisting in the generation of the necessary evidence to simultaneously support both the marketing authorisation of new medicines and their reimbursement. DLRC have successfully led these interactions for our clients to help optimise not only the regulatory but also the HTA strategy for their products.

Parallel FDA/CHMP Advice

The parallel scientific advice (PSA) programme was established by the EMA and FDA with the goal to encourage the dialogue between the agencies so sponsors could optimise product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies. DLRC are able to advise on those programmes where PSA may be of value as well as lead clients through the process from both Agencies.

Orphan Drug Applications

Rare diseases are a global issue, affecting millions of people around the world. Sponsors developing products intended for the treatment, prevention or diagnosis of a rare disease may be eligible for an Orphan Drug Designation (ODD) from the EMA and/or the FDA and other global agencies which comes with a range of incentives. DLRC has broad experience navigating the intricate legal framework and processes needed so our clients can readily access all the benefits ODD has to offer. Moreover, DLRC has EU legal entities meaning we can act as your EU representative and hold your ODD should your company not be established in the EU.

Paediatric Requirements

A global paediatric strategy is an essential requirement for new medicines and new indications for patent protected authorised products. DLRC consultants have extensive experience of paediatric requirements globally particularly in the EU, US and UK and can help you to optimise your paediatric development strategy and successfully negotiate paediatric plans with regulators.

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Paediatric Study Plan (PSP: USA)

In the US, an initial paediatric study plan (iPSP) is required for any new marketing application for non-orphan products and may be required for orphan products intended for the treatment of cancer.  DLRC can support your paediatric development by advising on strategy and/or by managing the PSP application process.

Paediatric Investigation Plan (PIP: EU/UK)

Paediatric investigation plans (PIP) are submitted to the European Medicines Agency Paediatric Committee (PDCO) and to the UK MHRA and must be agreed before a marketing authorisation application for your medicinal product can be validated. Once agreed plans frequently require modification as well as evidence of compliance. DLRC can support your paediatric development by advising on strategy and/or by managing the entire PIP application process to initial approval and beyond.

Non-clinical Protocol Development and Review

Optimised non-clinical studies that meet regulatory expectations and provide the right data to support clinical development are key to success in early phase development.  At DLRC we have in-house non-clinical regulatory experts who can help to define the requirements and ensure protocols are fit for purpose or even generate protocols on your behalf (also see our Medical and Scientific Writing Services).

Optimising Development

Regulators globally recognise the value brought by innovations driven by the pharmaceutical and devices industries and as such have a variety of mechanisms to provide additional support to developers of the most innovative and promising products to help them to optimise development.  DLRC has extensive experience of advising our clients on the products likely to be eligible for such schemes and successfully navigating the procedural and scientific aspects.

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PRIME

PRIME is a scheme launched by the EMA in 2016 to enhance support for the development of medicines that target an unmet medical need. Based on enhanced interaction and early dialogue between EMA and developers, this scheme aims to optimise development plans and speed up evaluation so medicines can reach patients earlier. DLRC have helped our clients to successfully gain and leverage PRIME designation and can advise on products eligible to the scheme as well as managing the process.

Fast Track

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. DLRC can help you to identify products that could benefit from Fast Track Designation and help manage to a successful conclusion.

Breakthrough Therapy Designation

Breakthrough Therapy Designation (BTD) is a process designed by the FDA to expedite the development and review of drugs that are intended to treat a serious condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). DLRC can help you to identify products that could be eligible for BTD

ILAP (UK)

The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market for new chemical entities, biological medicines, new indications and repurposed medicines, facilitating patient access to medicines in the UK. DLRC can help you to identify products that could benefit from ILAP designation and help you to navigate the process to gain and optimise the value of ILAP for your products.

Clinical Trials

Clinical trials are an essential part of any development programme and gaining timely regulatory approvals is key to their successful execution.  At DLRC we have extensive experience of regulatory aspects of clinical trials including providing advice on global regulatory trial strategy, advising on protocol requirements to minimise agency questions, over-seeing regulatory aspects of CRO activities, generating clinical trial documents (see our Medical and Scientific Writing services for further information on how we can support the generation of your clinical trial documents) and managing applications to competent authorities globally.

This includes:

INDs

An Investigational New Drug Application (IND) is submitted to the FDA to gain approval to conduct clinical trials in the USA. DLRC has extensive experience of the generation and maintenance of INDs at all stages of development including publishing and submission (see our Regulatory Operations and Publishing Services here for more information on our eCTD publishing capabilities).

Clinical Trial Applications

In order for a clinical trial to be conducted in the majority of countries globally, approval must first be obtained from the competent authority and ethics committee. DLRC have extensive experience of supporting clinical trial applications globally, including in the EU and UK.  DLRC are also experts on the implementation of the EU Clinical Trial Regulation (CTR) which has come into force in 2022 and will be mandatory for new trials applications from January 2023 (see our CTR Services for further information on how we can support your preparation for the CTR). From initial submissions to upload of clinical trial results data, DLRC is perfectly placed to support the full life cycle of your clinical trials.