BEYOND HEALTH CONSULTING
your BUSINESS CATALYST

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About what
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CRITICAL CATALYST is a team of specialised consultants in regulatory affairs for the medical apps, medical devices, cosmetic, food supplements and biocidal industries.

We provide strategic counseling and tailored project management to ensure compliance with regulations and market access requirements for your products and services. CRITICAL CATALYST creates a clear path for businesses fast-forward through the global regulatory complexity.

SERVICES
REGULATORY AFFAIRS

MEDICAL DEVICES

MANUFACTURERS - IMPORTERS - DISTRIBUTORS

Medical Devices Regulation and Obligations for different economic operators.
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MEDICAL SOFTWARE

Need to register you Medical Software or APP?

We develop custom made solutions that apply the best available regulatory and clinical knowledge to latest digital technology solutions in health.
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FOOD SUPPLEMENTS

Need to register your FOOD SUPPLEMENT?

We can help you step by step until market placement.
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SERVICES
COVID-19 PANDEMIC

PROTECTIVE GEAR

MANUFACTURERS - IMPORTERS - DISTRIBUTORS

PPE Regulation and Obligations for different economic operators.
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HAND SANITIZERS

Need to register your own HAND SANITIZER?

We can help you step by step until market placement.
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Critical Catalyst provides a wide range of regulatory and technical consulting services that guarantees, in a cost-effective way, the full compliance of cosmetics and medical products with all applicable legal requirements across international markets. Critical Catalyst portfolio includes manufacturers and distributors from several industries located worldwide.

Our company operates internationally rendering end-to-end regulatory services for placing medical devices, particularly medical software qualified as medical device under EU legislation, and cosmetic products on the market. Along with the regulatory and technical support, we review all stages of the product’s life-cycle and make a prospective analysis of its present and future regulatory needs.

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