Navigating Compliance with Confidence
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MANUFACTURER
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In the global healthcare market, regulatory compliance is not just about meeting legal requirements—it's a strategic advantage.
Our comprehensive outsourced Regulatory Affairs (RA) services are designed to simplify the complex regulatory landscape, ensuring your medical devices and biotech products achieve and maintain market access efficiently and effectively.
With specialized support for crucial roles such as Designated Individual and UK Representation, we're here to guide you every step of the way.
Regulatory Excellence​
Strategic Insight and Planning
Starting with your end goals in mind, we craft bespoke regulatory strategies that align with your business objectives and product lifecycle. Our global regulatory intelligence informs every decision, ensuring you're always ahead of the curve.
Seamless Market Entry and Maintenance
From pre-market submissions to ongoing compliance, our team navigates the intricacies of global and local regulations. Whether it's FDA approvals, CE marking, or UKCA marking, we streamline the process, saving you time and resources.
Post-Market Surveillance and Vigilance
Our vigilance doesn't end with market entry. We implement robust post-market surveillance and reporting systems to maintain compliance, ensuring your products continue to meet all regulatory standards.
Specialized Services for Global Compliance
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Designated Individual
For businesses within specific regulatory environments, our Designated Individual support ensures compliance with HTA legal obligations, overseeing product management, and upholding safety and quality standards.
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UK Representation
Navigate the post-Brexit landscape with our UK Representation services. We act as your UK Responsible Person (UKRP), managing MHRA registrations and communications, ensuring your products meet UK regulatory requirements.
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EXPERIENCE
IN..
DIAGNOSTICS
MEDTECH
SaMD
BIOLOGICS
SURGICAL
COMBO
FEMTECH
OUTSOURCED
BENEFITS
Reduce your OPEX and increase your team's, capacity, and capability.
Allowing you to grow faster.
Streamline Your Path to Compliance
Whether launching a startup or scaling an established enterprise, our regulatory outsourcing services offer a comprehensive solution to navigate the complexities of global compliance.
Benefit from our deep expertise and strategic insights to accelerate your product's journey from concept to market.
Tailored Regulatory Strategies
Our team of experts provides tailored regulatory strategies, ensuring your products meet stringent standards and achieve timely approvals.
By outsourcing regulatory tasks, you gain access to a wealth of knowledge and resources, allowing you to focus on innovation and core business growth.
PER YEAR
COST SAVINGS
Our Regulatory Affairs offerings are meticulously crafted to streamline your compliance journey across global markets.
By harnessing our deep expertise, including vital roles such as Designated Individual and UK Representation, we enable you to concentrate on innovation and business expansion. This approach ensures your regulatory commitments are in expert hands and unlocks significant cost savings by optimizing the regulatory process, reducing the need for in-house specialists, and mitigating the risk of non-compliance penalties. With us, your path to regulatory adherence is cost-effective and strategically sound, allowing you to dedicate your resources to where they truly matter.
Regulatory Outsourcing Savings for Startups and Scale-ups:
Regulatory Function | Estimated Savings in CAPEX (%) | Estimated Savings in OPEX (%) |
|---|---|---|
Post-market Surveillance
| 45% | 40% |
Regulatory Compliance
| 40% | 35% |
Clinical Evaluation Reports (CER)
| 50% | 45% |
Pre-market Submissions
| 45% | 40% |
Strategy and Intelligence
| 40% | 35% |
*Cost savings will vary depending on the maturity of your Products and size of business.
Regulatory Outsourcing Savings for Corporates:
Regulatory Function | Estimated Savings in CAPEX (%) | Estimated Savings in OPEX (%) |
|---|---|---|
Post-market Surveillance | 30-40% | 25-35% |
Regulatory Compliance | 25-35% | 20-30% |
Clinical Evaluation Reports (CER) | 30-40% | 25-35% |
Pre-market Submissions | 25-35% | 20-30% |
Strategy and Intelligence | 20-30% | 15-25% |
*Cost savings will vary depending on the maturity of your Products and size of business.
Ready to Navigate the Regulatory Landscape with Confidence?
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Partner with Us for Regulatory Excellence.
Let our outsourced regulatory services be the cornerstone of your strategy, providing the support and expertise you need to succeed in a competitive global marketplace.
