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Getting You the Help When You Need it Most
At Peak Regulatory Consulting we use the industry’s best consultants, contractors and staff to help you through your regulatory and quality management hurdles. Our resources can assist at every stage of the product lifecycle. With our extensive knowledge and experience in the medical device industry, we focus on Quality Assurance, Regulatory Affairs, and Project Management activities and have the knowledge and resources to help your product exceed the requirements to get to market in the USA, EU and the rest of the world.
Get the Right Resources - Wherever and Whenever You Need Them
Getting direct access to the specialized life science talent you need to bring your products to market is becoming more competitive and harder every day. Whether you’re looking for short or long-term support, we have the right resource for you.
We combine all of the services you need under one roof to ensure that you aren't jumping through unnecessary hoops and overspending. By providing you with access to a full complement of support by industry experts, our support and recommendations are based on personal knowledge and years of experience to ensure that your product has everything needed to meet your goals.
Here are some of the services we offer.
For a full list, schedule a free 30 minute consultation.
Quality Assurance
Trying to implement a quality system that is in compliance with the FDA regulations or get your company ISO 13485 certified? Or need help managing your current quality system? Use Peak Regulatory to build from scratch or augment your current Quality Management System (QMS). Our team of top talent will create, maintain, and help improve your QMS and make it audit ready.
We also help with the QC/QA functions on product development teams from design to manufacturing and help drive your projects to completion on-time and on-budget.
Regulatory Affairs
Trying to get a product through the FDA, NIOSH or get it CE Marked under the new EU’s MDR Regulations? Use Peak Regulatory’s team of industry experts to help develop and submit applications or augment your staff with industry experts to fill your regulatory needs.
We also help with the Regulatory functions on product development teams from design to manufacturing and help drive your projects to completion on-time and on-budget.
Are you a company that is located outside of the USA? We can also serve as your US Agent.
Project Management
Having a hard time staying on task or meeting your project timelines and milestones? Or are you working with a team that lacks the experience of getting you through the product development process and hurdles as quickly as you would like? Use Peak Regulatory to help you. We can come in and complete an engineering/project gap analysis and provide you with a project plan and then help you manage the project to that plan. Our Project Management team is highly talented and has years of experience with a deep working knowledge of the process and hurdles, and how to get through them faster. Let us help your product development team(s) go from design to manufacturing more quickly and efficiently and help drive your projects to completion on-time and on-budget.
You Deserve a Partner that Lives and Breathes Medical Devices
We are that partner. We help Medical Device companies, both large and small, with the resources they need, when and where they need them, through our optimal industry expert model.
We offer a FREE 30 minute consultation to evaluate your needs and to plan the next steps.