Plan in Line with Business Goals

CREATE with Expertise

Succeed with Confidence

Efficient Organisational Planning: Prioritising Within Business Needs

In the dynamic landscape of business, effective planning is crucial for success. Our consultancy specializes in organising planning strategies that revolve around your unique business needs. By setting clear priorities and aligning them with your broader objectives, we empower your organization to navigate challenges, seize opportunities, and achieve optimal outcomes.


EU-Medical Device Regulation

Bringing years of expertise, our EU-MDR consultancy excels in creating MDR-compliant technical files from scratch, ensuring strict adherence to the regulations of the European Union Medical Device Regulation. Rely on us to adeptly navigate complexities, enabling your medical devices to enter the European market confidently.

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US-FDA| 510(k) and PMA submission

Bringing years of expertise, our consultancy specializes in crafting 510(k) and PMA submissions for the US FDA. Our adept team ensures meticulous preparation, guiding your medical devices through the intricate pathways of FDA regulations. Count on us for successful market entry in the United States.

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Health Canada-Medical Device Application

Leveraging our extensive expertise, our consultancy specialises in crafting Medical Device License Applications for Health Canada.

Our capable team ensures meticulous preparation, guiding your devices through the intricacies of Canadian regulatory requirements.

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EU-In Vitro Diagnostics Regulation

With a wealth of experience, our consultancy excels in composing performance evaluation reports in alignment with the EU-IVDR.

Our adept team ensures meticulous preparation, guiding your In Vitro Diagnostic Devices through the complexities of European regulatory requirements.

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Strategic Regulatory Alignment: Integrating Compliance with Business Objectives

We collaborate closely with companies to align regulatory strategies with overall business goals. Our experts ensure that regulatory efforts are integrated seamlessly into your organisations broader strategy.


Technical Documentation Drafting

Our expert team specialises in creating these files, ensuring strict adherence to regulations like EU MDR, IVDR, and FDA requirements.

Literature Review & Appraisal

Our consultancy excels in evaluating and appraising relevant scientific literature, providing essential evidence on the state of the art of treatment.

Clinical evaluation

Our proficiency extends to drafting clinical evaluations to substantiate sufficient clinical evidence, or if additional clinical evidence is required.

Performance Evaluation

Our expertise covers support for creation of performance evaluations that encompass analytical, scientific, and clinical dimensions. We meticulously compile data, ensuring the coherent integration of each section.

Preparation of FDA Submission

We will compile and refine the finalised FDA submission in Electronic Common Technical Document (eCTD) format, to meet the exacting standards set by the FDA.

Medical Device License- Canada

By preparing a MDL application for Canada and drafting summaries, manufacturers can significantly improve their chances of successfully approvals for their devices.

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