Areas of Expertise
RegulatION
The regulations landscape is foggy and unpredictable. We take pride in demystifying the entire process, and guiding your products to market. We help create customized regulatory development strategies, and draft submissions for 510(k), PMA, 513(g) requests, HUD, HDE and IDEs. We prepare you for regulatory meetings so you have the strongest possible case, and for questions during the approval process. We help navigate the Electronic Common Technical Document (eCTD) process. We can act as a U.S. Agent for non-US companies.
Drug and biologics
We shepherd your drug through a complicated regulatory process, from submissions and pre-market review to post-market requirements such as safety monitoring.
product Quality, manufacturing & compliance
We are experts in the regulatory agency's compliance, inspection, and enforcement processes. We can assess your company's quality management systems, ensure Good Manufacturing Practice, and manage clinical site audits. We review and respond to regulatory correspondence and enforcement actions. We help your company proactively participate in the agency's Quality Initiative.
medical device
We help with requests for classification information (513(g)), 510(k) premarket notifications, premarket approval (PMA) applications, requests for de novo review of automatic class III classification, humanitarian use designation (HUD) and humanitarian device exemption (HDE) applications, and investigational device exemption (IDE) applications.
Business strategy
After years of experience in this landscape, we offer a unique perspective on our analysis of industry trends as they relate to company performance, as well as regulatory agency trends and priorities. We help devise marketing and promotional practices for maximum impact.
Clinical quality & gcp
We help manage risk by drafting clinical quality manuals, SOP's, and CAPA processes. We assist with GCP qualifying audits for sites and vendors, ongoing trials, and vendor audits including Contract Research Organizations (CROs), Central Labs, IRBs, and Data Management.