NAMSA’s Equivalency Evaluation evaluates the equivalency of a tool to a different related promoted solution. A typical request consists of equivalency pertaining to info and Homes for medical, specialized and Organic parameters, ways of use, resources and also equal clinical, technical and Organic Qualities overall performance.
Ongoing aid: Our dedication in your Business doesn’t conclusion with the supply of a session support. We have confidence in forging lasting partnerships, and as a result, we offer ongoing support and training to make certain your very long-time period GMP compliance.
Clinical Trials Change the design of medical research by integrating info, knowledge, analytics and technologies from examine structure by execution to electrical power much better choices.
When you've got a regulatory audit developing, be sure you are Prepared by aquiring a pre-audit by certainly one of our seasoned consultants.
Empowering sufferers to personalize their Health care and connecting them to caregivers has the probable to change the treatment shipping and delivery paradigm. IQVIA and Apple are collaborating to deliver this fascinating way forward for customized care straight to gadgets individuals have already got and use.
Irrespective of whether working on a stand-by itself FDA regulatory submission or within a partnership with our inter-disciplinary teams of Preclinical, Clinical, Biostatistics and Reimbursement Strategists, NAMSA possesses a confirmed background of effectively top Clientele pharmaceutical consultants by means of all stages with the item improvement procedure to mitigate regulatory hazards and obtain professional aims.
We’re one of the number of pharma consulting corporations that can help you navigate the difficulties associated with market polices.
Our regulatory consulting group of seasoned industry experts can provide your needs, whether or not your products is already in the marketplace. Irrespective of whether you require dossier content material management, a regulatory method or authorities to aid with transitional intervals in your enterprise, RCA® is your go-to source for professional compliance experts all through your product’s whole life cycle.
NSF 455 GMP Certification assists your company make certain safer merchandise, but it may help with the cost of insurance plan rates.
Improving human wellbeing needs courageous thinkers who will be willing to check out new Tips and Create on successes. Unleash your likely with us.
As your associates, we will negotiate the probable minefield of regulatory compliance and regulatory research with insight, hindsight, as well as apparent advantage of our exceptional know-how and experience.
During the intricate landscape of the European Union, well being technological innovation assessments and reimbursement regulations differ appreciably between member states. Our specialised Reimbursement staff is specialist in guiding companies from the complexities of reimbursement strategies, offering qualified insights and tailored methods for achievement in the ecu market place.
At Regulatory Compliance Associates, we comprehend client requirements are not one particular-size-fits-all throughout the pharmaceutical field. We provide an variety of regulatory services differentiated determined by drug corporations and exclusive medical consulting.
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