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Regulatory Submissions

Services/Regulatory Submissions

There is a big milestone between design & development and product launch which is approval or clearance by FDA to market your product. Or, in the case of the EU, many companies opt for a self-certification or CE mark to introduce their products into the European marketplace focusing on compliance with directives and ISO standards.

Do you need assistance in writing 510(k)’s, PMA’s, aNDA’s or NDA’s?  What about your technical file or clinical evaluation? Not sure if you are in compliance with requirements, directives or ISO standards?

We can help.  Using our knowledge of regulatory requirements, we write regulatory submission documents and assess supporting verification and validation information for adequacy. We make sure your information, which serves as your competitive advantage, is ready for review by global health authorities.Contact us today to see how we can help with your regulatory submissions, compliance and post marketing needs.

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MD & PC Mission Statement: 

Delivering compliant, audit ready quality system documents and solutions that support new product introductions, regulatory submissions and global quality system requirements for the medical device and pharmaceutical industries

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