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One-Stop Solution for all your Regulatory Requirements!

TIME CRITICAL SERVICES

Regulatory Strategy 

 

From idea to Commercialisation! 

Create a pathway to protect your innovation with complete compliance with regulatory requirements.

A well thought regulatory strategy enhances your production, business development and marketing plans.

 

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Representation Services

 

Regulatory First Responders for your medical device. 

We act as your EU AR / PRRC and represent your innovation to the European Commission! 

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EU AR/ PRRC 

Market Access 

 

Planning to enter the EU/USA?

Not sure about market entry requirements?

Worried about MDR/USFDA requirements?

We are here for you!

 

Contact Us Now!

YOUR Regulatory Risk Partners!

 

We have a list of ongoing and routine services through which we help our clients with complete regulatory compliance. 

Check our wide offerings for Medical Devices:

 

 

Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).

LATEST INSIGHTS

Understanding Device Classification and Predicate Device Searches in the US

Understanding Device Classification and Predicate Device Searches in the US

Launching a medical device in the United States requires navigating a complex regulatory environment governed by the U.S. Food and Drug Administration

13.8.2024

Sterilisation Validation Reports for Medical Devices

Sterilisation Validation Reports for Medical Devices

Sterilisation validation ensures that products are safe for patient use by eliminating all forms of microbial life.

9.8.2024

Steps in Launching a Medical Device in the USA: A 10-step guide

Steps in Launching a Medical Device in the USA: A 10-step guide

Is it really a 10 step process?

29.7.2024