We offer Regulatory Strategy support during all stages of clinical development. Our consultants have the experience to guide you to success in every project and in any therapeutic area. Ask us about our work!
Our team has hands-on and in-depth experience across all therapeutic areas and all stages of drug development. We understand how to align European regulatory requirements into your global development plan, taking an impartial and independent view, helping you to focus on the right activities and end-points to assist you in gaining regulatory approval.
Our aim is to help you to save time, costs and resources and increase your chances of success.
Pharma Design Limited has provided advice and direct support to large and small drug developers since 2009.
Clinical Trial Applications (CTA and modifications)
Pharma Design Limited can produce clinical trial applications on your behalf and submit them in EU, UK, Switzerland and Eastern European countries outside of the EU. Our consultants are skilled and experienced in the use of portals like CTIS, IRAS and others across the Region. We support our clients seamlessly from CTA submission to approval providing advice on how to resolve protocol-related issues and avoid unnecessary validation queries. Speak to us about your CTA management needs. Our prices and the quality of our support will beat any other Service Provider in Western Europe!
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 dozens of full Market Authorisation Applications MAA/NDA/BLA submissions over the past fifteen years. 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 and our prices will beat any other Service Provider in Western Europe!
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 Europe (including EMA, MHRA, SwissMedic and National Agencies) and the US FDA. We can assist you in planning and producing accurate and effective Briefing Packages and arrange for meetings. Since 2009, we have assisted our clients engaging Regulatory Authorities in Oncology, Psychiatry, Neurology, Immunology, Cardiovascular and Infective Diseases.
Paediatric Investigation Plan
We specialise in the production and submission of Paediatric Plans to European Agencies, including EMA, MHRA and Swiss Medic via their respective portals. Since 2009, we have produced and submitted 67 initial PIPs and 30 PIP modifications!
Only last year, we have submitted 15 initial PIPs to MHRA and 5 PIP modifications for mRNA products in a variety of therapeutic areas.
We have a thorough understanding of the Paediatric requirements in Europe and we can advise you on how to best position yourselves with the Agencies even if you are late in achieving agreement compared to your adult development program timeline or your MAA filing plans.
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.
Orphan Designation
We specialise in the production and submission of Orpha Designation applications to European Agencies, including EMA and Swiss Medic via their respective portals. Since 2009, we have produced and submitted 30 Orphan Designation applications in a variety of different therapeutic areas.
We have a thorough understanding of the Orphan requirements in Europe and we can advise you on how to best position yourselves with the Agencies even if you are late in achieving designation early during your development program and managing any changes that may be needed after designation.
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)755 798 3864 today for advice and assistance in pharmaceutical regulatory consulting.
Our Values
The value we bring to pharmaceutical companies falls into four main areas:
- Objective, impartial advice tailored to your needs
- Help cut your development costs
- Help reduce your time to market
- Keep your drug on the market