Strategic Planning - The key to successful regulatory approval is a comprehensive strategic regulatory plan that takes into account your business and marketing objectives, global regulatory requirements and potential risks, and is flexible enough to accommodate changes and still be successful. The best regulatory plan will be developed early in the product design process and modified as necessary to make sure the product is developed and tested to current global standards.
Clinical Study Design, Documentation and Project Management - Novel or high risk products will require clinical data to meet regulatory requirements or for market acceptance. The right clinical study design, documentation and management are essential for success.
Premarket Submissions - Premarket submission requirements are increasing in all geographies. At Heyer Regulatory Solutions, we make sure your submissions are comprehensive, well-written, and address all applicable regulatory requirements to get your products to market as quickly as possible.
Postmarket Surveillance - Regulatory agencies require varying levels of postmarket surveillance depending on risk, whether through active clinical data collection or passive adverse event / vigilence reporting. An effective postmarket surveillance system enables timely signal detection and action to assure that your products are working as intended.
Regulatory Compliance - Keeping your products on the market requires strict attention to compliance with postmarket regulations, including annual reports/recertifications, assessing changes to marketed products that may require regulatory submissions, filing adverse event reports (MDRs), and taking field actions when needed to address product defects.
Regulatory Agency Meetings - Clear and frequent communication with regulatory agencies is essential throughout the product lifecycle, including early determination of testing and data expectations, interim assessments to assure continued alignment, and postsubmission communications to address agency questions. Solid preparation and effective execution are essential to get the most out of your agency meetings.
Regulatory Due Diligence - When considering a partnership or acquisition, a thorough evaluation of the target company's regulatory status is essential due diligence. Heyer Regulatory Solutions tailors due diligence assessments to focus on the questions you need answered to identify potential regulatory risks and make the right business decisions.
Regulatory Intelligence - Global regulatory requirements and expectations are constantly changing. 510(k) Reform, Unique Device Identifiers, FDA's Innovation Initiative, EU "recast" of medical device regulation, and new requirements in China, Brazil and Saudi Arabia are just a few examples. Heyer Regulatory Solutions can help you keep up with regulatory changes to make sure you're always out in front.
Regulatory Systems - A highly effective regulatory team requires highly effective systems and processes to keep your company in compliance. Heyer Regulatory Solutions will work with your team to develop or optimize systems and procedures to meet your needs, including regulatory submission preparation, submission tracking, evaluating product changes, establishment registrations and listings, import and export requirements, complaint handling, risk management, and field action assessments.
Regulatory Seminars - Heyer Regulatory Solutions has extensive experience delivering regulatory seminars to large and small audiences. Whether you need "Introduction to Medical Device Regulation" for a broad audience or specialized modules that address the nuances of FDA and international premarket and postmarket requirements tailored for your products, Heyer Regulatory Solutions will work to make sure the training is right for your employees.
