WHAT WE DO
Regulatory Strategy & Market Access Planning
• Strategic advice on submission pathways across UK, EU, and international markets
• Product classification, regulatory risk mapping, and timeline optimisation
• Guidance for novel therapies and emerging technologies
• Product classification, regulatory risk mapping, and timeline optimisation
• Guidance for novel therapies and emerging technologies
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Dossier Compilation & Submission Support
• Full support with CTD/eCTD preparation and formatting
• End-to-end assistance for NDA, ANDA, MAA, IND, and variation filings
• Authoring and reviewing CMC Data, bridging data, and regulatory justifications
• End-to-end assistance for NDA, ANDA, MAA, IND, and variation filings
• Authoring and reviewing CMC Data, bridging data, and regulatory justifications
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Regulatory Intelligence & Gap Analysis
• Review of existing data packages against current regulatory requirements
• Gap identification and mitigation strategies
• Ongoing updates on evolving MHRA, EMA, and ICH guidelines
• Gap identification and mitigation strategies
• Ongoing updates on evolving MHRA, EMA, and ICH guidelines
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Labelling & Packaging Compliance
• End-to-end review of labelling, SmPC, PILs, cartons, and outer packaging
• Compliance with QRD templates and local market adaptations
• Lifecycle management of labelling updates and variations
• Compliance with QRD templates and local market adaptations
• Lifecycle management of labelling updates and variations
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Post-Approval & Lifecycle Support
• Change management, post-authorisation variations, renewals
• CMC support for updates to manufacturing, testing, or supply chain
• Regulatory documentation for global supply continuity
• CMC support for updates to manufacturing, testing, or supply chain
• Regulatory documentation for global supply continuity
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WHO WE WORK WITH
EARLY-STAGE START-UPS AND ACADEMIC SPINOUTS
MID-SIZED BIOTECH AND PHARMA
GLOBAL PHARMACEUTICAL COMPANIES REQUIRING REGULATORY REPRESENTATION
Whether you’re submitting your first application or managing a broad portfolio, we tailor our support to your structure and scale.
