In a complex and ever-evolving regulatory environment, ensuring compliance for your healthcare products is essential for their market access and continued commercialization.
At Universal Medica Group, we support pharmaceutical laboratories, medical device manufacturers, and biotech companies at every stage of the product lifecycle. With our regulatory affairs experts, we provide efficient dossier management and proactive monitoring to help you anticipate regulatory changes and secure your markets.
Why Is Rigorous Regulatory Affairs Management Essential?
- Ensure product compliance with health authority requirements
- Accelerate market access by optimizing registration processes
- Avoid non-compliance risks and regulatory penalties
- Optimize product lifecycle management in line with regulatory changes
Universal Medica Group also supports healthcare manufacturers and labs in obtaining reimbursement, setting pricing, and optimizing market access, ensuring a strategy aligned with regulatory requirements and payer expectations.
- Support in obtaining reimbursement and pricing approvals from health authorities (HAS, CEPS)
- Preparation of health-economic dossiers and value arguments to maximize market access
- Pricing strategy and negotiation with regulatory bodies
- Monitoring and analysis of French regulatory and market access changes
- Development of tailored market access strategies that meet product specifications and payer requirements
Our approach? Deep regulatory expertise, continuous monitoring, and tailored solutions to meet the needs of every healthcare company.
UNIVERSAL MEDICA offers comprehensive support—from regulatory strategy to ensuring the quality and safety of your products—to help you succeed in France and beyond.
UNIVERSAL MEDICA: Your competent partner with in-depth expertise in Regulatory Affairs.
For a project or any questions, contact us!
Our Regulatory Affairs Expertise
We provide comprehensive support for all regulatory procedures, from initial product registration to post-marketing maintenance. We assist clients with administrative obligations and interactions with regulatory authorities.
- Preparation and submission of regulatory filings and reports
- Liaising with health authorities and notified bodies
- Managing information requests and responding to authority inquiries
- Monitoring product status changes and related reporting obligations
Why Choose Us? We ensure responsive follow-up and effective communication with authorities to anticipate expectations and accelerate validation processes.
Why Choose Universal Medica Group for Your Regulatory Affairs?
- A team of regulatory experts with deep knowledge of international requirements
- Proactive regulatory monitoring to anticipate upcoming changes
- Tailored support to speed up market access and avoid regulatory bottlenecks
- A rigorous methodology combining compliance, traceability, and process optimization
- International presence to manage regulatory submissions across multiple markets
Universal Medica Group: Your Strategic Partner for Regulatory Compliance Success
Regulatory affairs management is a key success factor for healthcare industries.
With Universal Medica Group, benefit from expert, tailored support to ensure market access and product compliance while anticipating regulatory changes.
Need support in regulatory affairs? Contact us today and discover how we can help.
