NAMSA’s Equivalency Assessment evaluates the equivalency of a device to a different equivalent marketed item. A typical request includes equivalency concerning details and Attributes for scientific, technical and Organic parameters, methods of use, materials in addition to equivalent scientific, technological and biological properties overall performance.
Screening Analyzing how your items and services satisfy and exceed top quality, protection, sustainability and effectiveness criteria.
As Element of a medical device producer’s complex documentation and top quality administration method, chance management processes that adjust to ISO 14971 must be incorporated.
Receive expert comments on your own plant diagrams to prevent highly-priced redesigns of your respective design assignments. We'll assure your approach fulfills regulatory standards and upholds field finest practices.
Regulatory Compliance Associates pharma regulatory consultants will establish an extensive evidence guide of documented evidence demonstrating the corrective motion taken to remediate non-compliant issues.
With much more than twenty years of knowledge with FDA, Health copyright, EU and worldwide regulatory companies around the world, Regulatory Compliance Associates® presents leading pharmaceutical consultants. We’re among the several pharma consulting companies which will help you navigate the troubles affiliated with market regulations.
Pharmaceutical consulting is really a broad subject mostly offering assistance to pharma and biotech corporations that are creating and commercializing medicines. This specialty arena delivers prospects to professional men and women with specialized skills across a number of disciplines which includes approach and commercialization, solution progress and business enterprise growth.
Establishing IQVIA’s positions on essential trends from the pharma and life sciences industries, with a target EMEA.
Pharmaceutical consultants who provide technique and commercialization help, typically have a business track record constructed upon undergraduate research in click here science, combined with industry experience and frequently a learn’s degree for instance an MBA. Typical functions include possibility mapping, which will involve quantifying the reasonable business opportunity of pharmaceutical assets and companies, mapping out go-to-sector pathways as well as their associated crucial challenges and sensitivities, and developing goal product or service profiles (TPPs).
Our network of around five hundred FDA, Overall health copyright & MHRA veterans and marketplace experts offers a unique Mix of expertise that permits us to handle both straightforward and sophisticated regulatory compliance issues inside the health care system industry.
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IQVIA is uniquely positioned that can help connect analysis with commercialization, to help you optimize your drug development approach and concentration your investment decision on essentially the most promising compounds.
The dynamic regulatory landscape demands money establishments to determine demanding adherence programs whilst remaining versatile sufficient to adapt and improve. From synthesizing regulatory feed-back to introducing efficiencies and augmenting present greatest practices, FORVIS is here to aid.
Biological Safety & Validation Consulting A variety of medical products are launched Just about day-to-day in right now’s international marketplace, and that is generally marked Along with the challenge of adhering towards the market’s continuously changing Intercontinental requirements and rules. Setting up for biological basic safety is as much a business necessity as it is a regulatory need.