Nerac’s team of analysts provide regulatory support during and after market approval.
We guide and support new product development, continuously monitor safety and performance of products, and provide pre- and post-regulatory assistance.
With our unbiased, third-party reviews, we can help facilitate quicker regulatory approval of your submissions.
Our regulatory services include:
Medical Devices (Clinical Evaluation Reports, Technical Files, Clinical Literature Evaluations)
When you need information on medical devices that’s not readily available, Nerac delivers key results for your scientific, business, and marketing research.
We review, analyze, and organize the information according to your schedule and budget needs. Our clinical literature reviews include regulatory approval, reimbursement support, and regulation compliance. We also perform market studies to assess all aspects of your market, including any competing business activity.
Medical Devices (Regulatory and Reimbursement Services)
Whether you need to accelerate regulatory approval for your medical device or improve your reimbursement strategy, Nerac analysts help you achieve cost-effective results.
Because of the rapid changes in medical device reimbursement, Nerac supports you with an up-to-date coding strategy, pricing research, and effective communication to your payer audiences. Our clinical literature reviews and health outcomes data support you in all phases of your product development.
Food – Regulatory Compliance of Dietary Supplements
Nerac brings you over four decades of real-world experience in dietary supplement, nutraceutical and cosmeceutical research. We deliver the valuable R & D support you require for this highly regulated market, saving you significant time and money.
Whether you need on-going product monitoring, program development and alternatives, or market identification, our analyst team leverages the day-to-day technology challenges for your unique process.
Food – Regulatory Compliance of Packaging Materials
Nerac analyzes your food and pharmaceutical packaging components for regulatory compliance in the face of swiftly changing market technologies. We keep you current with key emerging technologies, new market opportunities, and the latest regulatory impacts.
Regardless of the packaging materials you require, we can quickly research patent, technical, and market information for your rapid and successful product development and market entry.
Regulatory Services (all industries)
Your new product idea requires thorough regulatory support and approval. Nerac provides all the necessary regulatory information governing your specific industry standard.
We research, identify, and monitor all levels of your market, according to the regulatory demands governing your industry. From new product support, through regulatory preparation and submission, to post-market surveillance, we assist you with your product’s safety and performance.
Nerac helps you to establish greater credibility and demonstrate clinical efficacy and safety early on. We help you avoid costly and potentially unnecessary clinical trials, while extending your regulatory team as needed and keeping your proprietary information protected.