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About Us
My name is Rabiea, I am an Associate Honorary Professor at UCL, former UK Health Authority Assessor (MHRA) and CEO of Entry to Regulatory and Advance Regulatory Consulting.
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I have over a decade of regulatory affairs experience leading multimillion-dollar regulatory submissions across the globe to secure regulatory approvals for large pharma and biotech companies, such as GSK, MSD, Bayer, Biogen and others. I have worked across the full lifecycle, from pre-clinical trials through to clinical trials, commercialisation and lifecycle maintenance and have gained numerous approvals without any Agency questions.
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But, despite my extensive regulatory affairs experience and passion for helping companies develop and deliver lifesaving medicines, I also enjoy training other life science, healthcare and regulatory professionals. My aim is to help you excel in your regulatory career and grow the profession, so that we can accelerate innovation and deliver for patients.
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If you are ready to kick-start or excel in your regulatory career, then I am here to support you.
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I train life science, healthcare, pharmacy, medical, chemistry and regulatory professionals by giving you the knowledge, experience and mentoring to excel in your career.
Book an Introductory Call with Us
Let's talk about how our experts can help you with your needs
We look forward to helping you
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How Can We Help You?
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Full lifecycle support - from early development clinical trials, through to major agency submissions (MAA, NDA, BLA) and post-approval maintenance.
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Support for biological, small molecule, branded and generic products.
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Submission authoring, agency interaction, regulatory strategy, risk mitigation, site transfers and compliance.
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US, EU, UK and rest of world markets
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​Entry courses - junior professionals
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Excel courses - mid-level professionals
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Expand courses - senior professionals
We have worked with:
Our Success Case Studies
Our Feedback is Outstanding
They understand and interpret the regulations well and they are an excellent technical writer. They work well in a matrix team environment and are a pleasure to work with
Director
GSK
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
I had the pleasure of working with them 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 whereby they remained pleasant and good humoured throughout the entire process.
Associate Director
MSD
I have worked with them on a manufacturing site registration/transfer project for a multimillion pound EU/ROW product. 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 and past experience working for a regulatory agency significantly helped them to 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.
Consultant
Bayer
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