Regulatory information
Over the years, the required knowledge base for the regulatory affairs profession has increased in complexity, breadth and depth. The Food and Drug Administration (FDA) has expanded its compliance requirements to align with internationally harmonized requirements from the European Union (EU), International Conference for Harmonization (ICH), and others.
Professional competencies
Today’s regulatory professional must have competencies in product approval requirements, quality system requirements, product design and engineering requirements, and more detailed topics depending on the criticality and type of device or drug, and affected geographies. Read more about professional regulatory competencies.
Our regulatory services
Whatever your regulatory needs, Medical Devices and Pharma provides regulatory services to companies in the medical device and pharmaceutical industries. So if you find that you would like to add a regulatory professional to your team, or a team of regulatory professionals, we can help.
Laws, regulations and regulatory documentation can be difficult to understand and interpret, especially for companies and individuals that are new to the industry or not otherwise familiar with legal requirements and guidelines. Add to that the need to stay up to date with current regulatory news, information, and trends, and the complexity of the profession becomes even more daunting.
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We recommend that you bookmark this space, because Medical Devices and Pharma will provide updates on regulatory news and events, as well as solid interpretation, analysis, and opinions to help you navigate through the national and international regulatory environments.
510(k) Submissions
Let’s connect
Consider us as a colleague and advisor if you are planning a new product or product design change, are not completely sure about compliance requirements, or have regulatory enforcement issues that you need to resolve. Some examples of the services we provide follow. And if you have any questions about these or other regulatory areas of expertise, please contact us.
ICH: The International Council for Harmonization
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a pivotal role in shaping global pharmaceutical practices, ensuring the quality, safety, and efficacy of medicines worldwide.The International Council...
The IMDRF: International Regulators
The International Medical Device Regulators Forum (IMDRF) plays a pivotal role in shaping global regulatory approaches and standards for medical devices, enhancing safety and innovation across international borders.The International Medical Device Regulators Forum...
Regulatory Information
FDA Breakthrough Devices Program
Program assists needed products with access to US market The U.S. Food and Drug Administration (FDA) has established the Breakthrough Devices Program, a voluntary program that aims to expedite the development, assessment, and review of medical devices that demonstrate...
A Team-based Approach to an Expedited 510(k)
Getting an expedited 510(k) submission So, you have created a new medical device by following your quality system’s design controls to plan the project, define design inputs, test to verify that outputs meet inputs, and validated your production product. Now what?...
Regulatory Documentation for National and Global Market Access
With a solid base of technical documentation, our regulatory specialists will prepare a regulatory submission that is organized, well written, complete, and meets the regulatory requirements of the agency that will evaluate the product.
FDA Information – Conveniently Organized and Accessible
Quickly find the FDA information you need Conveniently organized FDA information. The U.S. Food and Drug Administration (FDA) provides a wealth of information for consumers and industry stakeholders. The problem is, it can be difficult to navigate to the information...
FDA Announces Online Electronic 510(k) Submissions
The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022. The electronic Submission Template and Resource (eSTAR) electronic submissions template is a...