Regulatory Affairs

Regulatory folders

Our services include:

Regulatory submissions in Canada and the USA: Health Canada, FDA, REBs, IRBs (CTA, ITA, IND, BLA, NDA, NDS, 510K, and more).

Together with our associated professionals, we can also help you submit in South Africa and Israel.

How we can help:

Provide you with outlines for those documents and review the various drafts up until a document of high quality is completed; or
Develop a collaborative approach whereby we prepare the documentation for your review, implement your comments and make the submission when the collaborative process is completed.

Regulatory affairs are a very broad and crucial part of a healthcare product. Significant differences exist not only between various product types (drugs, biologics, medical devices), but also between various jurisdictions (US, Canada, EU, Japan and other countries).

Depending on your product and your resources, we can help you develop a successful regulatory strategy that will save you money. We are aware of the advantages and disadvantages of the regulatory frameworks in different countries and can advise you accordingly. Thus, you will be able to receive approval earlier in one jurisdiction and use the income from selling the product to obtain regulatory clearance in other, stricter jurisdictions.

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