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Regulatory 1

Navigating Compliance with Confidence

SERVICE

OUR

Are you overwhelmed by regulatory requirements?

 

We manage the entire compliance process, reducing your administrative burden and providing considerable savings on regulatory costs while ensuring faster market entry.

Our Regulatory Service is designed to navigate the complex landscape of medical device regulations, ensuring your products meet all necessary standards for market approval.

 

We provide comprehensive support, from developing regulatory strategies to managing submissions and compliance audits.

OUTSOURCING 
INCLUDES: 

Strategic Insight and Planning

Market Entry and Maintenance

Post-Market Surveillance and Vigilance

UK Representation (UKIP)

Designated Individual (Human Tissue)

Why Outsource to Us?

Expert Guidance

Leverage our deep knowledge of global regulatory requirements

Efficiency and Accuracy

Ensure timely and error-free submissions for quicker market entry.

Resource Optimisation

Focus on innovation while we manage regulatory complexities.

Ongoing Support

Stay compliant with evolving regulations through continuous monitoring.

BUILT

FOR

MANUFACTURER

IMPORTER

DISTRIBUTOR

DEVELOPER

OUR

APPROACH

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

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.

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.

EXPERIENCE

IN..

DIAGNOSTICS

MEDTECH

SaMD

BIOLOGICS

SURGICAL

COMBO

FEMTECH

Regulatory

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?

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.

CAPABILITIES

OUR

CHAT

LET's

Discuss how our customized regulatory outsourcing solutions can streamline your compliance processes, reduce overheads, and accelerate market access.

 

Together, we can achieve regulatory excellence and drive your business forward.

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