Welcome to Start Regulatory

Compliance by deisgn......

We are a professional life sciences services and consulting company specialising in quality and regulatory compliance services. Our experienced team offers a variety of advisory, development and validation services to help you achieve success in regulatory filings and certifications.


Compliance by Design

EU CLINICAL TRIAL REGULATION CONSULTANCY

We have navigated through the complexities of the EU Clinical Trial Regulation (and CTIS) providing strategic support to our Clients for optimal operational delivery.

SOP WRITING

Operational experts leading operational processes, change management through to implementation ensuring compliance at a systemic level.

CLINICAL TRIAL APPLICATIONS

Expertise in supporting global clinical trial applications, providing a range of support from strategic advice through to submissions and maintenance activities.

Regulatory Consultancy

At Start Regulatory we help you understand how the global regulations apply to you and the pathway to achieve your objectives with maximum efficiencies.  Our primary goal is to guide you through the product development pathway providing expert services at varies stages of global regulations for optimal compliance.

Whether it's a marketing authorisation application, labelling or a variation via the national, mutual or centralised route we can provide the strategic solution with expert knowledge in ICH GCP, FDA, EMA, CTIS (EU CTR) and other applicable country regulations, partnering with you to make the journey less burdensome and successful.  
EU Clinical Trial Regulation
Our team of regulatory experts have navigated themselves around the complexities of Regulation (EU) 536/2014 (Clinical Trial Regulation) and the working practices of the EMA Clinical Trial Information System (CTIS).

Our strong team of professionals are able to expedite timelines with our methodical planning strategies defining your deliverables. Applying dedication to your project assessing at every stage of the regulatory pathway so that nothing is left to chance.

Ensuring regulatory approvals are achievable with risk mitigation strategies applied and never leaving behind the 'quality by design' principles and the integrity of the project.
SOP Writing
Our subject matter experts in Start Regulatory understand the end-to-end operational process of drug development so when it comes to writing SOPs we can adopt your project needs.  Often your company internal experts are busy with operational delivery and not able to dedicate the time needed to facilitate process improvements through a change management process. so why not come to Start Regulatory who can apply strategic thinking to creating your SOPs to reduce the risk of noncompliance and potential inspection findings. We can also offer tailored training for your functional teams.
Clinical Trial Applications
Our Regulatory Team has been responsible for successful submissions to major competent authorities and regulatory agencies and have navigated through the complexities of EU Clinical Trial Regulation.  

We provide expertise throughout the life-cycle of the clinical trial with the unique ability to leverage capabilities and global functional experts, engaging with teams in strategy and implementation.

Our skilled teams develop high-quality regulatory documents that are compliant with global and national regulatory requirements.

Introduction

Maxine Blake-Ainslie

Executive Vice President

With over 30 years of experience in pharma, biotech and CRO Maxine has led teams in regulatory operations, governance & compliance and clinical trial operational project management. This extensive knowledge can be applied to your project needs with professional leadership and strategic approach. At Start Regulatory we are a specialist regulatory consultancy bringing years of experience to bring life to your project from early development to market access and operational support.

Contact Us

We look forward to hearing from you should you wish to discuss some of our services.