NAMSA’s Equivalency Assessment evaluates the equivalency of a device to another related marketed merchandise. A typical request contains equivalency regarding knowledge and Qualities for scientific, technical and biological parameters, ways of use, components and also equal clinical, technological and biological Attributes functionality.

Regardless of whether you require guidance with doc compilation for the regulatory submission or a spot Assessment assessment prior to publishing to your Notified Human body, NAMSA is right here to aid!

NAMSA gives complete analyses detailing suitable and deficient locations (Hole) in between an present set of knowledge and new regulatory demands for devices, which include reviews of remediation and sequence recommendations.

Assurance Enabling you to identify and mitigate the intrinsic threat within your functions, offer chains and quality administration units.

At the outset in the regulatory project if a maker has determined that there's no lawfully promoted predicate machine to foundation a 510(k).

Remain educated on essential regulatory necessities, improvements, updates, and notices. Intertek's marketplace involvement gives you the data you have to know when you need to know it.

Regulatory Compliance Associates good quality assurance services include things like top quality authorities with experience spanning key organizations and start-ups. Our pharmaceutical consulting company is aware firsthand how to achieve, preserve, and strengthen excellent. Finally, our regulatory compliance services team excels in transferring constant advancement know-how for your Corporation.

Our regulatory consulting group of seasoned professionals can provide your needs, even when your products is currently that you can buy. Regardless of whether you would like file written content management, a regulatory technique or authorities to help with transitional intervals in your enterprise, RCA® is your go-to source for professional compliance specialists through your product or service’s overall lifestyle cycle.

Our more info FDA 510k consultants will make a customized tactic based on your merchandise as well as your pharma corporation’s person needs. Our consumers include things like:

The resulting connect with to complete extra While using the very same or much less sources highlights the need for increased focus on transformation—Innovative agreement lifecycle administration becoming a first-rate example.

We comprehend the necessity of with the ability to Plainly establish requirements early in the procedure so as to mitigate pitfalls and accomplish a successful result.

The regulations approach encompassing pharmaceutical businesses is often tricky for even probably the most expert business veteran to know. Just one misstep by FDA consulting corporations could imply sizeable and lasting repercussions for shopper income and sector profitability.

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