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Advance Regulatory Consulting
Expert Regulatory Services

Accelerating Innovation  |  Delivering for Patients 

About Us

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.

How Can We Help You?

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Regulatory Affairs

Consulting

  • Full lifecycle support - from early development clinical trials, through to major agency submissions (MAA, NDA, BLA) and post-approval maintenance.

  • Support for biological, small molecule, branded and generic products.

  • Submission authoring, agency interaction, regulatory strategy, risk mitigation, site transfers and compliance.

  • US, EU, UK and rest of world markets

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Regulatory

Professional

Regulatory Affairs Training Course

  • Bespoke in-house training

  • ​Entry courses - junior professionals

  • Excel courses - mid-level professionals

  • Expand courses - senior professionals

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Introduction to Regulatory Affairs Courses

We Have Worked With

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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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