Advance Regulatory Consulting
Expert Regulatory Services
Accelerating Innovation | Delivering for Patients
We are a leading product development and regulatory affairs consulting practice serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market, minimising development costs and ensuring continued supply. We keep our client's needs and the patients who benefit at the heart of what we do.
A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed.
Our team offers strategic and operational support in the fields of CMC and regulatory, which guide products efficiently from early development to marketing approval and post-approval maintenance.
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Our Success Case Studies
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Supporting pharmaceutical companies to drive innovative medicines throughout the drug discovery process and into markets for use by patients by providing our regulatory services, such as regulatory affairs consulting and regulatory training courses to support their professionals
Delivering for Patients
Ensuring patients benefit from innovative medicines. Patients are at the focus of everything we do. For everything we do, we ask, how will the patient benefit from this activity? We take an ethical approach to our work and maintain high standards.
Dauntless in spirit
Contribute to Society
Our customers are at the centre of what we do. We provide end to end solutions to accelerate innovation and deliver for patients. We drive success through win-win outcomes.
We deliver our goals with the greatest level of professionalism and conduct and are authoritative in what we do.
We aim high, remain competitive, strive to achieve our goals, and never give up.
We are at the forefront of the latest developments in the regulatory space. We keep our knowledge up to date, evaluate new developments and contribute to the progression of the regulatory profession.
We support and empower professional knowledge sharing.
We aspire to help people lead longer, healthier lives.
Rabiea, Managing Director
I am a UK registered pharmacist with around ten years of regulatory affairs experience gained from working in the UK regulatory health authority (MHRA) as an Assessor and several global pharmaceutical companies companies, such as, GSK, MSD and Bayer.
My experience covers the entire product lifecycle, from clinical trial applications through to new drug applications and post-approval changes. I have worked on various different medicinal products, including biologicals, vaccines, medical device combinations, consumer products (OTC), small molecule and generic medicinal products.
I have successfully delivered multimillion-dollar regulatory approvals and cost savings repeatedly for several pharmaceutical companies throughout the EU, US, UK, and the rest of world markets.
I am passionate about regulatory affairs and providing exceptional regulatory support for pharmaceutical companies to accelerate innovation and deliver for patients. Furthermore, I am passionate about training other regulatory professionals in complex regulatory topics.
Our Feedback Is Outstanding
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 has 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 supported change assessments, submissions and regulatory strategy. Their extensive knowledge of EU requirements has been very valuable for the success of the program as they always came up with constructive suggestions and assessments.
Associate Director, MSD
Their deep knowledge and understanding of the EU requirements and HAs expectations were extremely helpful. They are hardworking, dedicated and always willing to go the extra step. They are a great asset to any CMC team.
Associate Director, MSD
They are talented regulatory professionals, they understand and interpret the regulations well and are excellent technical writers
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.
They consistently show strong leadership capabilities when it comes to directing, supporting, and involving peers... Proving to be knowledgeable in their area of expertise.
They always attend meetings prepared and do not miss an opportunity to progress a task, initiative, or deliver the next stage in the process.
Quality Manager, Biogen
They have completed one of our more challenging submissions, providing some expert input and writing for the submitted IMPD. They have provided some insight and direction into a more structured authoring, review and approval process for regulatory submissions.
Head of Manufacturing, Small Biotech
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.
They have always been very responsive in responding to my questions. Their regulatory expertise has been very 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, along with answering challenging agency questions. They are highly effective and are always proactive and intuitive in their approach.
Their expertise in CMC helped them bring solutions for the toughest of deficiency letters enabling numerous agency approvals to be gained. They are able to manage, execute and delegate for multiple projects simultaneously and within deadlines. I highly recommend them.
Their leadership, CMC regulatory expertise, and operational awareness have been invaluable in helping the team remain on track to completing the IND submission.
They are well organized, have excellent communicational skills, both oral and written...they are knowledgeable, self-motivated, work with a sense of urgency, and are great team players.
I had the pleasure of working with them, as part of a collaborative effort to intensively support a critical CMC submission with a range of complex changes... The overall strategy resulted in up to 14 hours intensive preparation per day for one week.
They supported the review and critical analysis of the submission to ensure conformance and right first time submission. It was a pleasure to work with them at all times and tantamount to their personality
Associate Director, MSD