Professional regulatory and quality services
Medical Devices and Pharma provides regulatory services to clients and consumers. National and international regulatory requirements are derived from national-level government lawmaking entities that have a goal of protecting their citizens from ineffective and unsafe medical devices and pharmaceutical products.
The laws are then translated into regulations and other documentation that can be difficult to understand and interpret, especially for companies and individuals that are new to the industry or not otherwise familiar with legal guidelines. Examples include specific requirements for market access to a country or region, product approval and surveillance requirements, and specific requirements for field actions or removals.
510(k) Submissions
U.S. Agent/Correspondent
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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.
Regulatory compliance interpretation and information
Regulations cover all aspects of your product lifecycle, from designing and getting market approval for a product to manufacturing, packaging and labeling, distribution, and use of the product, to include market surveillance, field actions, and recalls.
Compliance often relies on following very specific regulatory requirements – and if your company does not follow them, it can result in enforcement actions and other sanctions that would bring negative publicity to your company and its products.
Quality system compliance audits
Prior to the implementation of FDA’s QMSR is a good time to check the compliance of your quality management system. We will audit your QMS to the QSR and QSMR.
Regulatory writing
Many companies are refused market access because their marketing application was not well written or otherwise did not include details required by the regulatory agency.
Regulatory documentation products such as market clearance submissions, correspondence, and reports often have specific content and format requirements, and must be written in an acceptable regulatory writing style. In addition, they must be written in a manner that is clear, concise, and well organized.
Our regulatory writing experts can help to guarantee the success of your regulatory documentation project by generating impeccable products that present technical content in complete and easy-to-understand terms.
Regulatory strategy and submissions
It is imperative for the business units of regulated companies to understand the intricacies, costs, potential benefits, and time frames for national and international product applications and approvals. And those details become more complicated as more global countries and regions are involved.
Let us help to guide you to develop and execute a regulatory strategy for the market introduction and reimbursement for your medical device or pharmaceutical product.
FDA meetings and communication
Do you have questions for FDA about requirements for your IDE, PMA, HDE, De Novo, or IND application? We can schedule, conduct, and document your Q-sub meetings in accordance with FDA guidance.
Recalls and corrections / Crisis management
Is your company the recipient of an FDA Warning Letter or target of another FDA enforcement action? There are specific, time-sensitive requirements for actions you must take, including making responses to the agency.
If you are not sure about the complete details of what or how your company must do in those situations, contact us for assistance.
US agent and correspondent
Are you a foreign device or pharmaceutical manufacturer looking to establish a presence in the US? Medical Devices and Pharma LLC also offers administrative functions as a US agent or US correspondent.