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End-to-end regulatory expertise

From initial strategy to post-market surveillance, our team handles every stage of the regulatory journey — covering three specialist domains.

Regvista empowers Biopharma companies, life sciences organisations, and start-ups to navigate UK/EU regulatory requirements efficiently and cost-effectively. Discover our range of tailored services designed to accelerate your market access and ensure full compliance.

Within Tech Domain, we provide Advisory Services on AI integration across drug discovery, clinical trials, manufacturing, and pharmacovigilance; regulatory strategy and compliance for AI/ML tools under EMA, MHRA, and EU AI Act; data governance and validation frameworks to ensure transparency, quality, and patient data protection; and help biopharma organizations adopt AI responsibly and effectively.

Within IP Domain, we provide End-to-end regulatory and IP strategy, including AI-enabled tools; patent landscaping, filings, and freedom-to-operate assessments to protect innovations; guidance on data/market exclusivity and lifecycle management in the EU; and regulatory submissions and compliance support to ensure smooth approvals and competitive advantage.

Market Entry Strategy & Authorisation

Our expert consultants guide you through the complex process of entering UK and EU markets, ensuring your products achieve Marketing Authorisation Holder (MAH) status. We customise regulatory pathways, facilitate dossier preparation, and support your submissions for faster approvals.

Regulatory Compliance Management

Stay compliant and reduce operational risks with our comprehensive compliance management solutions. We handle ongoing regulatory obligations, pharmacovigilance, and post-market surveillance, helping you manage costs while maintaining the highest standards.

Customised Consultancy & Cost Optimisation

Benefit from bespoke consultancy tailored for your business needs. We support start-ups and growing companies with budget-friendly, scalable solutions—helping you optimise regulatory spend without compromising on quality or compliance.

Starter Consultancy

Ideal for start-ups and emerging businesses entering the pharmaceutical and life sciences sectors in the UK/EU. This plan is perfect for those seeking essential regulatory guidance with a clear, manageable budget.

Pricing per hour

What's Included

Initial regulatory assessment
Tailored compliance roadmap
Access to regulatory updates
One revision of documentation

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Growth MAH Support

Designed for prospective Marketing Authorisation Holders (MAH) looking to expand market access efficiently. Benefit from comprehensive support to manage ongoing compliance and facilitate UK/EU market penetration.

Pricing per project/month

Features

Ongoing regulatory support
Dossier preparation and review
Submission management
MHRA/EMA liaison
Quarterly training sessions

Contact for Custom Plan

Full Suite Enterprise

Tailored for established pharmaceutical and life sciences organisations requiring a complete regulatory affairs solution. This plan offers end-to-end support for complex projects and robust compliance management.

Custom Pricingper engagement

Plan Includes

Dedicated regulatory affairs manager
Full project lifecycle management
Comprehensive compliance audits
Bespoke regulatory strategy development
Priority support & updates

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Your trusted UK/EU regulatory partner

Post-Brexit dual access

Our UK base gives us unique positioning to act as your UK partner while facilitating EU submissions — a strategic advantage in the post-Brexit landscape.

Joined-up expertise

Rare combination of biopharma, AI/digital health, and IP regulatory expertise under one roof — no need to manage multiple specialist advisors.

Built for start-ups

We understand the budget pressures of early-stage companies and design our engagements to be scalable, flexible, and cost-effective from day one.

Every step covered

From initial regulatory strategy and dossier prep through to post-market surveillance and ongoing compliance — we're with you for the full journey.