We provide end-to-end regulatory affairs services throughout the entire lifecycle of your medicinal product – from early development clinical trials, through to major agency submissions (NDA, MAA, BLA) and post-approval maintenance.
Our experience covers all types of medicinal products, markets (EU, US, UK and rest of world) and therapeutic areas, involving small molecules, biologicals, biosimilars, branded and generic products. We accelerate innovation through our highly-respected regulatory affairs team, who have decades of experience in delivering regulatory solutions and strategic guidance to a wide portfolio of clients, tackling some of the most technically challenging projects, delivering successful client outcomes that are flexible and cost-effective and that offer exceptional value to clients from both commercial and scientific standpoints.
Furthermore, we deliver for patients and keep them at the center of what we do. Whilst performing all of our services, we are conscience of the impact to patients, and this drives us to be the best at what we do.
Let’s talk about how our experts can help you with your regulatory challenges and needs
We look forward to helping you achieve your regulatory objectives
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If you require support in an area not mentioned above, then don’t hesitate to contact us and we can work with you to provide a solution
“They have an excellent approach when working through challenging regulatory assessments. I have found their critical thinking and analytical skills to be highly beneficial. They have a wealth of regulatory experience to draw from”
Principle Scientist, MSD
“Their ability to lead the team as challenging and unexpected situations arise makes the collaboration very effective. They demonstrated competency, teamwork, ownership and dedication to their work. They are a valuable asset to any team.”
Associate Director, MSD
“They are talented regulatory professionals, they understand and interpret the regulations well and are excellent technical writers”
Director, GSK
“I had the pleasure of working with them on an extremely busy & challenging product... They are highly capable and knowledgeable Regulatory Professionals and would be a benefit to any team.”
Director, MSD
“They have a strong technical background, an immense knowledge of regulatory, organizational skills and ability to execute efficiently... their expertise has been valuable in proactively identifying and addressing any potential gaps that can lead to future questions from agencies.”
Senior Scientist, Biogen
“For a manufacturing site registration/transfer project they were involved in creating and coordinating the response strategy, writing and compiling module 3 and technical documents... Their expertise in CMC helped them bring solutions for the toughest of deficiency letters enabling numerous agency approvals to be gained. I highly recommend them.”
Consultant, Bayer
At Advance Regulatory Consulting, We tailor our services to fit your budget and requirements
We take on:
We provide regulatory services to the following markets:
🇪🇺 Europe (EU)
🇺🇸 United States (US)
🇬🇧 United Kingdom (UK)
🇨🇭 European dependent markets (e.g. Switzerland, Ukraine, CIS markets)
🇦🇪 Middle East (e.g. UAE, Qatar, Oman, Saudi Arabia, Iran, Kuwait)
🇭🇰 Asia (e.g. Hong Kong, South Korea, Singapore)
🇿🇦 Africa (e.g. South Africa)
🇹🇷 Turkey
🇨🇦 Canada
🇦🇺 Australia
🇷🇺 Russia
🇨🇳 China
🇯🇵 Japan
🇧🇷 Brazil
🇲🇽 Mexico
If you require services for a market not included in the list, then contact us to enquire.
Get in touch to discuss how we can accelerate your regulatory programme
