We provide tailored regulatory solutions, expert guidance, and proactive support for successful submissions.
Kaizen Regulatory Consultancy (KRC) is a premier regulatory affairs consultancy committed to delivering expert guidance and solutions across a wide range of pharmaceutical sectors. Our team of highly qualified and experienced RA/CMC professionals brings advanced expertise in the regulatory landscapes of the UK, Ireland, EU and ROW.
We specialise in navigating the complexities of Biologics, Small Molecules, Biosimilars, GMOs, Combination Products and Generics. With a deep understanding of various therapeutic areas such as cardiovascular, oncology, haematology, ophthalmology and more. KRC is your trusted partner in ensuring regulatory success at every stage of development.
Let us help you streamline your regulatory processes and accelerate your journey to market.
Kaizen Regulatory Consultancy (KRC) supports clients large and small, across a wide range of products including small molecules, biologics, advanced therapy products and generics.
Marketing Authorisation Application/Post-marketing Authorisation Submission/ Manufacturer Site Registration
We provide comprehensive business support and due diligence services, ensuring informed decision-making, risk mitigation, and regulatory compliance for your success.
Our data entry services ensure accuracy, efficiency, and confidentiality, helping you manage, organize, and process critical information with precision and reliability.
Accelerate approvals and ensure compliance with KRC’s expert regulatory support. Contact us today for tailored solutions to streamline your submissions.
At Kaizen Regulatory Consultancy (KRC) we are dedicated to supporting your drug development programmes from first-time submissions to ongoing maintenance throughout the product lifecycle. Ensuring regulatory success at every step. We combine our extensive human expertise with forward thinking data insights and proactive solutions.
We believe in integrity, innovation, and a client-focus approach. Our commitment to excellence ensures that we always put our clients’ needs at the forefront of everything we do.This powerful synergy enables us to provide tailored solutions and expert guidance, ensuring that every regulatory submission is strategically aligned for success.
Expert regulatory guidance, strategic solutions, and seamless compliance to accelerate drug development and ensure successful market entry worldwide.
We prioritize your needs, offering personalized regulatory solutions and dedicated support for seamless market success.
We provide data-driven, customized regulatory strategies to navigate complex requirements and accelerate market approval efficiently.
Our team of certified experts ensures compliance, accuracy, and efficiency in every regulatory submission and process.
We prioritize your needs, providing personalized regulatory solutions with clear communication and dedicated support at every step.
Navigating regulatory complexities with expertise, innovation, and integrity to ensure seamless compliance and successful market entry for your pharmaceutical solutions.