Regulatory Affairs Consulting
Accelerating Innovation, Delivering for Patients
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.
Book an Introductory Call with Us
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
Or send us an email
We Have Worked With
Our Services
Early Development Clinical Trials
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Early Development Regulatory Strategy
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Agency meetings, Scientific Advice / Protocol Assistance
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Advisory Committee meetings & preparation
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Clinical Trial Filing (CTA and IND)
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Investigator Brochure / IMPD / IND authoring
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Risk management planning
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Early Access Programs, PRIME, Breakthrough Therapy Designation
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Paediatric Investigation Plans (PIPs), Orphan Designations
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Expert Advice (Quality)
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Global Regulatory Intelligence
Marketing Authorisations
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Authoring of MAA, NDA, BLA, ANDA submissions
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Regulatory Strategy
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Risk management
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Full procedure support for US and EU application procedures (National, MRP, DCP, CP)
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Module 1 preparation
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Module 2 Quality Overall Summary
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Module 3 Quality
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Artwork and Labelling (including Summary of Product Characteristics (SmPC), Company Core Data Sheets (CCDS), Product Information Leaflets (PIL) etc.)
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Support for pre-submission meetings
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Local regulatory intelligence and support
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Response to Agency questions
Lifecycle Management
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Variations
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Amendments/supplements
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Regulatory strategy
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Risk management
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Product licence renewals
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Annual reports
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Line extensions
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Artwork and labelling
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Technical authoring
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Submission management
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Expansion into new markets
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Regulatory intelligence
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Local submission support
Other Activities
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Project Management
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Medical Writing (e.g. IMPD, NDAs)
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Change control assessment
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Advice and consultancy
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CMC Gap Analysis
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Data collection and collation
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Adjudication
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Remediation
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Health Authority communication
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Manufacturing site rationalization
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Site transfers
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Change of ownership
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Due-diligence and divestment
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CMC compliance
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CTD build and conversion projects
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Process Improvements
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Training
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Program SWOT analysis
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
Our Successful Submissions
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 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.
Consultant, Bayer
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.
Director, Biogen
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
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 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
At Advance Regulatory Consulting,
We tailor our services to fit your budget and requirements
Speak to our experts now
We take on:
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Small projects will lower budgets
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Large projects with high resource requirements
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One-off projects
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Part time or full time consultant requirements
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Full outsourcing of regulatory activities
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One- off regulatory advice calls
Your Challenges, Our Solutions
Are you facing any of the following regulatory challenges for your submissions?
Here is how we can help with these challenge:
❌ High workload and low regulatory resource
✅ We have regulatory resource to support your high workload
❌ An incomplete understanding of all regulatory risks associated with your product
✅ We can complete a regulatory risk assessment for your product
❌ Unawareness of how much information in your submission is too much
✅ We can help you reduce information in your submissions to reduce regulatory burden and costs
❌ Compliance issues that you are unsure how to resolve
✅ We can resolve your compliance issues
❌ Lack of resource to create your regulatory submission in the required timeframe
✅ We have experts who can create your regulatory submission in the required timeframe
❌ Unawareness of how to deal with known developmental risks
✅ We can create mitigation actions for developmental risks
❌ Unfamiliarity with preparing regulatory submissions
✅ We have extensive experience in preparing regulatory submissions and can support you
❌ Use of inefficient regulatory processes and systems that are slowing things down
✅ We can review and optimise your regulatory processes and systems
❌ Too many Agency questions received for your submission
✅ We have received no Agency questions for many submissions and can help you do the same
❌ Unawareness of nuances associated with Agency requirements for various new technology platforms (e.g. ATMPs, mRNA, pDNA)
✅ We can guide you through the nuances associated with Agency requirements for new technology platforms
❌ Unawareness of how to create a suitable regulatory strategy for your product
✅ We can create a regulatory strategy for your product
❌ Need to improve the team's knowledge on a certain regulatory topic
✅ We can provide bespoke regulatory affairs training to you and your team
❌ Need to improve the efficiency of creating regulatory submissions
✅ We have delivered regulatory submissions quickly and to a high standard
❌ Unawareness of UK, EU, US or rest of world Agency requirements for your product
✅ We can advise you on the UK, EU, US or rest of world Agency requirements for your product
❌ Unfamiliarity with Regulatory Agency meetings
✅ We have attended Regulatory Agency meetings and know what the Regulators require
Let us help you... Contact us today
Global Regulatory Solutions
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.