Regulatory Affairs

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    Diamond BioPharm Ltd have an experienced team that are able to apply their expertise to a clients project in a subjective and uncompromised approach.

    The regulatory team and advisory board consists of a wide variety of professionals that provide extensive and expert advice.

    Product Development

    The Regulatory framework around development of a medicinal product is a complex maze of legislation, guidance notes and concept papers. For any company developing a product it is crucial to have sound input from experienced Regulatory Affairs professionals, to ensure that your resulting product will move successfully through Regulatory Authority assessment.

    Diamond BioPharm Limited can provide support to you by -

    • Providing Regulatory guidance for the development of your products whether they are new chemical entities, biotechnology, generic or biosimilars.
    • Inputting at all stages - chemical and pharmaceutical, preclinical and clinical - of product development to ensure the Regulatory needs are met, drawing from our vast array of experiences.

    Taking on a responsibility of Project Team Leader where necessary, and steering your company through the product development process from start to end.

    Regulatory Strategies

    What is a Regulatory strategy?

    Many people often question what role Regulatory Affairs can play in strategic planning both during product development and also following authorisation and launch of a product. By the very nature of the discipline of Regulatory Affairs, a Regulatory professional will be exposed to most aspects surrounding a product and will interface with the majority of key individuals both within and external to the pharmaceutical company. This places a Regulatory person in exactly the right position to be able to formulate a strategy taking account of every angle.

    Diamond BioPharm Limited has a wealth of knowledge and experience to bring to the forefront for strategic planning and thinking, and thereby -

    • Assisting in development of your strategies throughout the development process what data and studies will be needed
    • Highlight critical issues in all areas chemical and pharmaceutical, pre-clinical, clinical, prescribing information - and assist in providing solutions and 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 in order for your products to be registered throughout Europe
    • Advising on the most appropriate route for submission throughout Europe (national, Decentralised, Mutual Recognition or Centralised), considering the pros and cons of each
    • Advise on scenarios around life-cycle planning

    Regulatory Procedures

    There are now four possible routes to authorisation of products within Europe, largely dependent upon the type of product to be authorised. The choice of procedure for your particular product should be one of the key factors that are considered when you are devising your Regulatory strategy, long before the actual submission date. There will be many drivers and options for considerations before that decision can be made. Even if your product is mandated to use the Centralised Procedure, you will need to understand the procedure, consider how best to liaise with the authorities, what options are available for dialogue, timelines and many more factors.

    Diamond BioPharm Limited can help you with -

    • Providing full assistance and advice on all European procedures national, Mutual Recognition, Decentralised, Centralised and US FDA expertise
    • Assistance in seeking Scientific Advice as required
    • Support from submission, throughout the chosen procedure to final Marketing Authorisation
    • Liaison with Regulatory Authorities on your behalf
    • Strategic input into the choice of procedure for your product
    • Review of potential options such as orphan drug, accelerated review, exceptional circumstances, options for small and medium sized enterprises (SMEs)

    Preparation of Dossiers

    A huge amount of expense and effort is put towards product development, in terms of resource, people and money. The end aim of this is to produce a Regulatory dossier for submission to the Regulators to ensure successful authorisation and launch of your product. A proportional amount of resource should be put into the compilation and preparation of any dossier to ensure it meets the requirements in terms of content, format and quality of presentation. This is what the Regulators will read, review and use to make an assessment of your product. A well-presented dossier is the first step to making a good impression.

    Diamond BioPharm Limited can assist with the preparation of all types of dossiers for submission across Europe, including -

    • Full Marketing Authorisation Applications
    • Abridged Marketing Authorisation Applications
    • Bibliographic applications
    • Quality Overall Summaries
    • NTA to CTD conversions
    • Variations Type I and Type II
    • Clinical Trial Applications
    • Orphan Drug Designation applications

    Interim Man Management

    Finding the right Regulatory Managers for your Regulatory Affairs Department is an increasingly difficult task in the present environment.

    Having had many years of setting up and leading Regulatory Affairs functions within some major companies, Diamond BioPharm Limited can -

    • Provide Man Management cover, whilst you search for the right calibre of people for your company

    Regulatory Training

    The value of training your Regulatory staff to be able to develop, perform the tasks required and fully contribute to their best ability within your company should not be underestimated. Regulatory Affairs is the central function within in an organisation, touching most areas. Regulatory staff need to have the ability to contribute at all levels and widely across the organisation. Sound training in Regulatory Affairs skills will give them the confidence to enable them to do this.

    Diamond BioPharm Limited can provide training for your staff, either one-to-one or in groups, on:

    • A wide range of areas within the discipline of Regulatory Affairs variations, marketing applications, clinical trial applications
    • European Procedures, Clinical Trials Directive, New Legislation
    • Strategic thinking
    • An insight into product development
    • In depth assessment of data requirements in chemistry and pharmaceutical, preclinical and clinical
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