Development Stage Regulatory Affairs Support

The regulatory framework around the development of medicinal products is a complex maze of legislation, guidance notes and concept papers. When developing a product it is crucial to have sound input from experienced regulatory affairs professionals to ensure that your product will move successfully through assessment by regulatory authorities. We can support you by:

  • providing regulatory guidance for the development of your products whether they are new chemical entities, biotechnology, biosimilar or advanced therapy medicinal products
  • giving input into chemical and pharmaceutical, preclinical and clinical plans for the development of your products to ensure that they meet regulatory expectations
  • taking on project manager responsibility where necessary and steering your company through the product development process from start to end
  • coordinating national and EMA scientific advice at the right time and preparing briefing documents
  • leading the coordination and writing of IMPDs, INDs, IBs, Orphan Applications, Paediatric Investigation Plans, PRIME applications etc.
 

Regulatory Strategy

A clear and well considered development plan is an essential part of all successful clinical programmes. Once all aspects of the development programme and product related needs are clear, it is possible to forge ahead and build a regulatory strategy on a solid foundation. The regulatory strategy may also identify accelerated routes to market or help to overcome regulatory hurdles through development.
Our team can help to finesse your regulatory strategy:

  • assist in the formulation of your strategies throughout development and guide the level of detail required
  • highlight critical issues in all areas from CMC, non-clinical and clinical and assist with implementing contingency plans
  • clarify and highlight the impact of emerging and existing legislation and guidelines
  • ensure that the right regulatory conditions and data requirements are in place for registration throughout Europe
  • advise on the most appropriate route of submission throughout Europe and consider accelerated pathways to market.

We have written and assembled thorough regulatory development plans and EU/US regulatory roadmaps for a wide variety of products in development, including:

  • gene therapies (multiple viral vector system)
  • cell therapies & gene modified cell therapies
  • a range of small molecule new chemical entities, with full technology transfer support
  • biologics, including novel oral biologic anti-infectives.
 

Scientific Advice

Identifying gaps in a development programme and establishing a regulatory plan is an essential first step. However, there are always areas that require clarification and even negotiation with appropriate regulatory authorities. This can be achieved by taking scientific advice.

Over the past 10 years, we have prepared hundreds of briefing documents for clients seeking advice on their non-clinical and clinical data packages with the EMA and national agencies.

  • We are highly experienced in leading scientific advice meetings and in steering interaction with the experts to obtain useful advice and guidance for the client to further develop their product.
  • There is a wealth of experience within the team to guide clients to obtain optimal feedback across CMC, non-clinical and clinical questions.

Our experience extends to conventional scientific advice, protocol assistance and innovation task force initiatives. We provide support for FDA advice in collaboration with our US network. We have written and submitted briefing documents for a range of products and guided clients through the process.

 

Orphan Applications

Over the last 5 years, we have successfully applied for over 20 Orphan drug designations across a breadth of rare disorders and product types. Our team take the lead in assembling the necessary documentation from source documents and we guide the process through to conclusion with the Committee for Orphan Medicinal Products (COMP) at the EMA. Diamond Pharma Services B.V. will hold our Orphan Designations to pre-empt complications due to the risk of a hard-Brexit scenario.

 

PRIME Designation

Launched in 2016, PRIME is a scheme to enhance support for the development of medicines that target an unmet medical need. PRIME is similar in scope and intent to the FDA’s Breakthrough Therapy Designation.

We were successful in gaining approval for a client in the first wave of PRIME applications. Since the scheme started, we have gained significant experience in understanding both the programme’s needs and expectations for successful interactions with the EMA.

 

Medical Writing and Regulatory Dossiers

Our team are experienced in writing regulatory dossiers and we excel in liaising with Sponsors, third-party manufacturers and CROs to extract the information needed to deliver cohesive regulatory dossiers for a wide range of purposes:

  • Briefing Documents
  • Investigational Medicinal Product Dossiers (IMPDs)
  • Investigational New Drug Applications (IND), with eCTD support
  • Investigator's Brochures (IB)

We use a fully validated Extedo eCTD systems to publish both EU and US dossiers for meetings and INDs. The Diamond team are a balance of experienced regulatory professionals and former Biotech/Pharma development staff, with particular expertise in the area of Chemistry Manufacturing & Controls (CMC) and non-clinical matters. Where necessary, our team work closely with independent medical advisors, or with the client’s internal clinical teams.

 

SME Status

Our SME qualifying clients can abridge to our SME status at EMA. We also have SME status via our EU headquarters and the related legal entity in The Netherlands, Diamond Pharma Services B.V. This ensures business continuity in the event of a Hard-Brexit scenario.

 

Evolving Procedural Landscape and Early Access Schemes

We remain at the forefront of regulatory science by monitoring the evolving procedures and incentives offered by national agencies and the EMA. Examples include the Early Access to Medicines Scheme and Promising Innovative Medicines Designations being rolled out by the MHRA. We have helped clients to gain access to these schemes within the UK.

 

Support in the United States

We work in collaboration with a network of US contacts to cover a broad range of programme needs. The network includes the provision of subject matter experts across a range of product types, across all stages of development and with FDA-facing experience. The inhouse Diamond team control publishing activities and the network can provide US Agent support.