SERVICE MODEL
Our goal is to provide guidance, education, and practical support throughout your journey to market. We offer a wide range of services that are customizable and can easily adapt to your organization’s changing needs. We also offer our clients the ability to scale our services up or down as they see fit, so you only pay for exactly what you need when you need it.
While we specialize in the areas listed below, we are also happy to help with other related projects, just contact us to enquire.
Service Areas
Regulatory Strategy & Submissions
We can help you navigate the complex regulatory requirements for Class I & II medical devices in the US and abroad, assist with regulatory submissions, and help you plan and implement compliant policies and procedures.
Quality Management Systems
We can prepare policies, procedures, forms, and templates for quality management systems in compliance with the FDA’s Quality System Regulation (21 CFR 820) and the international standard for medical device quality systems (ISO 13485).
Technical Documentation
We can write requirements specifications, test protocols, user handbooks, and many more technical documents essential to your commercialization efforts.
Grants & Contracts
We can assist with applications for funding, from simple writing and editing support to full submission preparation. We are equally well versed in administering grants and contracts, preparing reports, and partnering on complex projects.
Clinical Research Support
We are experienced in planning and writing research protocols, interfacing with institutional review boards, and preparing scientific journal articles for publication.
Service Areas
Regulatory Strategy & Submissions
We can help you navigate the complex regulatory requirements for Class I & II medical devices in the US and abroad, assist with regulatory submissions, and help you plan and implement compliant policies and procedures.
Quality Management Systems
We can prepare policies, procedures, forms, and templates for quality management systems in compliance with the FDA’s Quality System Regulation (21 CFR 820) and the international standard for medical device quality systems (ISO 13485).
Technical Documentation
We can write requirements specifications, test protocols, user handbooks, and many more technical documents essential to your commercialization efforts.
Grants & Contracts
We can assist with applications for funding, from simple writing and editing support to full submission preparation. We are equally well versed in administering grants and contracts, as well as preparing reports and partnering on complex projects.
Clinical Research Support
We are experienced in planning and writing research protocols, interfacing with institutional review boards, and preparing scientific journal articles for publication, including the creation of effective figures and tables.