Understanding the complexities surrounding the EU regulatory requirements and how to implement them plays a critical role throughout the development and ongoing maintenance of any new drug.
By getting it right, first time, and having an experienced team to hand to give you high level strategic advice and support to keep you on track, greatly increases your product’s chances of getting to market and reaching patients.
The PhD team has hands-on and in-depth experience across all therapeutic areas and all stages of a drugs development. We understand how to incorporate the EU regulatory requirements into your development plan, taking an impartial and independent view, helping you to focus on the right activities and end-points to assist you in gaining EU regulatory approval.
We understand how the EU differs from other regulatory requirements and can give you practical support to gain approval for your product in Europe. Or if you already have a presence in Europe, we can become an extension to your team to get your product to market and keep it there.
Our aim is to help you to save time, costs and resources and increase your chances of success.
Pharma Design provides apecialist advice on the regulatory requirements concerned in the development and supply of pharmaceuticals. We can work with you at all stages of the process from development and manufacturing to address legal constraints, restrictions and requirements based on current legislation. Areas of expertise include the following:
Clinical Trial Applications (CTA and variations)
PharmaDesign can produce clinical trial applications on your behalf or help with completing applications for you to submit. Our work extends to producing and updating your calendars, chasing Authorities for responses and combining and updating applications and variations.
EU Marketing Applications (MA)
We assist companies in applying for centralised or decentralised marketing applications. We have experience in answering requests from EMA and National Competent Authorities in order to facilitate the communication of a positive Risk/Benefit balance to regulators. PhD has successfully co-managed the delivery of 2 full Market Authorisation Applications (MAAs)/NDAs/BLAs and supported more than 20 additional submissions over the past five years. This work has included the preparation of all CTD sections. Through this extensive exposure to the regulatory requirements and the realities of submission management in all its facets, PhD provides you with a comprehensive expertise that is very difficult to match in any one pharmaceutical company.
Scientific Advice and Briefing Packages
We assist companies in applying for Scientific Advice to gather feedback from Regulatory Authorities before submitting Marketing Applications or before initiating Clinical Trials. We have a long experience in dealing with all Regulatory Authorities in EU (including EMA) and US FDA. We can write Briefing Packages and arrange for the actual meetings, whether you would like to attend by yourselves or would like us to represent you at the meeting.
Paediatric Investigation Plan
A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of a medicine for children. Pharmaceutical companies submit proposals for PIPs to the European Medicines Agency’s Paediatric Committee (PDCO). This Committee is responsible for agreeing or refusing the plan. The normal development of a medicine requires that various studies be performed to ensure its quality, safety and efficacy. PIPs:
- include a description of the studies and of the measures to adapt the medicine’s formulation to make its use more acceptable in children, such as use of a liquid formulation rather than large tablets;
- cover the needs of all age groups of children, from birth to adolescence;
- define the timing of studies in children compared to adults.
The development plan for a medicine can be modified at a later stage as knowledge increases. Modifications can also be made if the applicant encounters such difficulties with the implementation of a PIP, which render it unworkable or no longer appropriate.
In some cases, studies can be deferred until after the studies in adults have been conducted. This ensures that research in children is done only when it is safe and ethical to do so. Even when studies are deferred, the PIP will include details of the paediatric studies and their timelines.
Risk Management Plans (RMP)
Risk Management Plans are complex projects with a huge potential impact on your pharmaceutical product’s success. Pharma Design can tailor pharmaceutical project management and production according to the new GVP Module V and depending on the type and complexity of the product. If you supply us with all the relevant data required for all sections, we can compile full Risk Management Plans. A close, continued collaboration with the sponsor is required and, when developing these projects, Pharma Design becomes a functional interim collaborator of the client.
Risk/Benefit Analyses (RBA) & Art 31 Referrals
RBAs generally refer to non-clinical and early clinical data available to justify further development or to assist in the production of protocols, but they can be extended to provide answers to regulatory authorities on a number of occasions. More recently, the eveluation of the Risk/Benefit profile of compounds is gaining relevance in the decision whether to proceed with the development program or not as marketing strategies and market pricing more and more will depend on a rather favourable Risk/Benefit balance. We can assist you with responses to PRAC in relation to art 31 requests for information.
Clinical Study Report Production (CSR Production)
Pharma Design can write, review and complete a clinical study report for submission. We maintain the upmost confidentiality of your clinical study results and development product and we guarantee to deliver our work on time and with complete accuracy, 100% review and targeted QC. Due to the nature of this task, we will require you to provide us with full datasets, data analysis and all information for specific sections.
If you require training in pharmaceutical regulation, please see our Auditing & Training section. Call +44(0)20 3875 4111 or +353 (0)1 902 0049 today for advice and assistance in pharmaceutical regulatory consulting.