TNTC is a leading provider of technical consulting services and resources to the pharmaceutical, biotechnology, medical device, and combination product industries. TNTC provides complete project teams including project management, quality, regulatory and technical resources.
Our professionals have diverse experience and capabilities in project management, commissioning, qualification, engineering, quality assurance, and regulatory affairs gained from years of successful experience working within operating companies.TNTC has been a major contributor to our client's successes on critical projects.
Our professionals have diverse experience and capabilities in project management, commissioning, qualification, engineering, quality assurance, and regulatory affairs gained from years of successful experience working within operating companies.TNTC has been a major contributor to our client's successes on critical projects.
Services
TNTC begins each project by Intense Research, Intelligent Inquisition and Unrelenting Determination to meet our client's needs and requirements. TNTC provides exceptional value by focusing on delivery of our most valuable assets; project managers and technical professionals. Our strategy is based on the belief that a consulting company that delivers the right talent, methodology and a dedication to excellent services will succeed for our client.
TNTC begins each project by defining obtainable objectives with the goal of delivering upon the objective on time and on-budget. Our project managers are focused on serving the client and responding to the client's needs and expectations. Each client has unique needs and each project brings unique challenges.
TNTC offers comprehensive Regulatory Program Delivery (RPD) services and will help you achieve successful approvals worldwide. At TNTC, RPD starts with a well thought out regulatory strategy designed specifically for the client product requirements. RPD is a complex process, with specific requirements related to medicinal products, medical devices or food supplements.
TNTC Inc. has project managers (PMs) and engineers experienced in Process and Product Qualification and Validation. Through our process oriented methodologies (POM) we provide maximum value throughout the process/product lifecycle.
Using the same methodology, TNTC can provide risk based product qualification for medical devices and combination products utilizing applicable FDA guidelines and regulations in (21 CFR Parts 210 and 211), Active Pharmaceutical Ingredients (ICH Q7A), and for Medical Devices (21 CFR Part 820).Required elements and information can be easily included on your design history file (DHF) or DMR (device master record).
Using the same methodology, TNTC can provide risk based product qualification for medical devices and combination products utilizing applicable FDA guidelines and regulations in (21 CFR Parts 210 and 211), Active Pharmaceutical Ingredients (ICH Q7A), and for Medical Devices (21 CFR Part 820).Required elements and information can be easily included on your design history file (DHF) or DMR (device master record).
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