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Our healthcare regulatory affairs services
We provide healthcare regulatory affairs services in the EU to help you navigate the complexities of global pharmaceutical regulations for your medicinal product.
Guiding you through healthcare regulatory challenges
Our team of experts provides comprehensive regulatory expertise throughout your product’s lifecycle, ensuring a smooth and efficient path to market approval.
We support you throughout your:
Development phase
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Regulatory support during the development programme, including manufacturing and control aspects
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Regulatory assistance for the definition of specifications and stability protocol
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Preparing regulatory quality documents for clinical trial application (Investigational Medicinal Product Dossier)
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Preparing Module 2–5 of Registration Dossier.
Transfer phase
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Designing regulatory affairs strategies, including evaluating the technical transfer programme and providing guidance
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Preparing variations package related to the transfer process.
Lifecycle management
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Designing regulatory affairs strategies for product reclassification, product reformulation and line extension
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Preparing regulatory variation package for application.
Our collaborative approach and efficient communication ensure you’re always informed and involved in the process. We’re dedicated to improving timelines and maximising your chances of success, contributing to your overall project goals.
Regulatory affairs services
Manufacturing
Our diverse technologies and experienced team ensure the high-quality and efficient production of your product.
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Technology Transfer
Our flexible approach to tech transfer adapts to your unique requirements and timelines.
Learn moreYour success is our success
We’re more than just a service provider; we’re your dedicated partner in navigating the complex world of regulatory affairs. With over 30 years of experience, our team understands the challenges you face and is committed to helping you achieve your regulatory goals.
We believe in open communication and transparency, keeping you informed and involved every step of the way. Our team works closely with yours, fostering a collaborative environment where expertise is shared, and challenges are overcome together.
Global regulatory expertise anchored in experience
Our team has the expertise and experience to support your regulatory team’s efforts in markets around the world, including Asia and South America.
We’ll help you:
- Understand the regulatory-specific requirements of each market
- Prepare the requested necessary documentation for registration and variations
- Minimise potential delays and ensure a smooth approval process.
With our global approach and extensive experience working with our clients’ regulatory teams, you can confidently navigate the complexities of international regulatory landscapes and bring your products to patients worldwide.
Ready to discuss your next project?
As your CDMO partner, we’re dedicated to providing exceptional service and support throughout our partnership to ensure your project thrives – because your success is our priority.
Let’s explore the possibilities together.