Consultancy
We advise companies on a wide range of regulatory issues. Please contact us to discuss your particular requirements.
Regulatory Strategy
We can help you consider the best options to achieve your regulatory and business objectives. For example: Which is the most appropriate regulatory procedure to achieve the fastest approval in target markets? How to maximise opportunities for line extensions of existing products?
Regulatory Intelligence
We can help with desk based research to establish the regulatory environment for your products.
Gap Analysis
For example: a review of an existing dossier [from an overseas market, or an older product] to identify what is required to bring it into line with current EU requirements.
Regulatory Due Diligence
For licensing and acquisition - are the dossiers for offered products up to current standards?
Good Manufacturing Practice
Advice on GMP issues for pharmaceutical products and medical devices
Legal Category
Switches from POM to P and P to GSL.....
Appropriate legal category for new marketing authorisation applications....
Mentoring and Support
We are pleased to offer regulatory advice to small and early stage companies and can also offer mentoring and support where companies are taking on their first employees in a regulatory or QA role.
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