NAMSA’s Equivalency Assessment evaluates the equivalency of a tool to another similar marketed merchandise. A standard request features equivalency with regards to facts and Attributes for medical, specialized and biological parameters, ways of use, elements along with equal clinical, technological and biological properties overall performance.
Expertise in the regulations is not really adequate. Familiarity with the various worldwide regulatory groups as well as their Tastes is important to accomplish essentially the most productive and effective outcomes.
Regulatory authorities usually do not contemplate ISO, GMP or other certificates for being ample evidence of excellent, therefore you might be required to accomplish an audit on a regular basis.
RCA operates with both equally Global Fortune a hundred companies and little community start out-ups, together with regulation companies requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer abilities in a number of health-related fields, this sort of
Additionally, the timeframe for your assessment of a medicinal consultation file could be lengthy and pricey. These timeframes are dependent on if the medicinal component is really a regarded material to your Proficient Authority and from the acknowledged supply.
Where does your Firm want to go? Take a look at our latest scenario studies to see how we can help get you there. And check back again For additional stories as we add to the gathering.
At NAMSA, we offer An array of biological basic safety options to be certain your health-related device growth plan is compliant, when also focusing on quite possibly the most productive usually means feasible to accomplish essential get more info tests.
By using a nicely-prepared layout, in addition to entire visibility of product or service progress and the availability chain, RCA may help bolster your system’s cybersecurity posture through.
Our FDA 510k consultants will make a custom made solution depending on your products and also your pharma company’s personal wants. Our clientele include:
As your husband or wife, we can easily negotiate the potential assessment minefield of regulatory compliance services with Perception, hindsight, as well as the obvious advantage of our breadth and depth of knowledge and regulatory compliance consulting. We provide the next pharma consulting regulatory affairs services for pharmaceutical organizations.
Industry rules: These are the most often encountered by corporations, and they generally exist to help you make sure products continue to be as Protected and productive as possible.
The thoughts and statements During this blog are These of your authors and don't always mirror These of BRG. This weblog relies on personalized encounter and assessments of information publicly offered or recognized in other database lookups.
We enable clients safe numerous types of life science means for the two contracted and direct seek the services of engagements with the best combination of qualifications, expertise, and drive for succeeding in difficult and demanding jobs.
Regulatory Compliance Associates has major experience as well as a demonstrated approach to running FDA Warning Letters, Consent Decrees, Remediation and also other severe regulatory scenarios. Our pharma consultants learn how to spouse with government, legal, and interaction teams, and will guide administration having a response that may be approved because of the regulatory company and be realistic to execute.