Services.
Medical Devices
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We are experts in the medical device industry and we offer state of the art e-QMS systems along with other services required for businesses to get into the Medical Device world. We have highly trained consultants to help you through ISO 13485:2016 + MDSAP (all jurisdictions) + EU MDR.
Overcoming the regulatory hurdles may be challenging to navigate and fulfill, but the markets have consistently proven that the regulatory burdens are well worth overcoming for the return on investment. With our expertise, we can get your products onto the market quickly and smoothly. Send us an email to get started.
Services We Offer:
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Medical Device Application License
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Facility Establishment Licenses
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Internal Audit (ISO 13485:2016 + MDSAP + EU MDR)
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External Audit Sit-In
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Unique e-QMS building & support
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UDI Registrations
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Design and Development Consulting
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Other
Natural Health Products
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Natural Health Products (dietary supplements) includes a variety of healthcare products with natural ingredients. This is an industry that continues to grow at an incredible rate and we have the capability to meet the demands. It is believed in Canada, NHPs are estimated to exceed $5 billion in sales, and globally exceed $400 billion.
Overcoming the regulatory hurdles may be challenging to navigate and fulfill, but the markets have consistently proven that the regulatory burdens are well worth overcoming for the return on investment. But with our expertise, we can get your products onto the market quickly and smoothly. Click here to start!
Services We Offer:
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Site License Registration
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NHP Product Licenses
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Site Audit Prep
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Consulting
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Other
Cosmetics
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We have a group of expert consultants here to help you get your product onto the market with cosmetic notification forms.
Overcoming the regulatory hurdles may be challenging to navigate and fulfill, but the markets have consistently proven that the regulatory burdens are well worth overcoming for the return on investment. But with our expertise, we can get your products onto the market quickly and smoothly. Email us to start!
Services We Offer:
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Cosmetic Notification Forms
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Ingredient list analysis
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Label Reviews and generations
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Consulting
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Other
Drug and Over the Counter Rx
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We have a group of expert consultants here to help you get your product onto the market with DIN applications and DEL audit preparations.
Overcoming the regulatory hurdles may be challenging to navigate and fulfill, but the markets have consistently proven that the regulatory burdens are well worth overcoming for the return on investment. But with our expertise, we can get your products onto the market quickly and smoothly. Email us to start!
Services We Offer:
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DIN applications
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DEL audit preparation