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Covid-19 Notice

MDI CONSULTANTS SUPPORT DURING THE CORONAVIRUS PANDEMIC

Dear Clients and Partners,

As the world continues to navigate through the Coronavirus pandemic, we wanted to update all our current clients, partners and those companies in need of future assistance on what mdi Consultants is doing to provide the highest level of regulatory consulting services and most importantly, uninterrupted support.

mdi has been in business since 1978 and collectively, we accumulated 100’s of years of unmatched expertise in all areas of FDA and other international regulatory bodies compliance. We are committed to safeguarding the health and safety of our employees so they can continue to be relied on as a trusted asset to your organization.

We are following the CDC guidelines as well as recommendations of local New York State and county officials with regards to hygiene practices, minimizing close contact and group assembly requirements. Every one of our employees has complete capabilities to work remotely with full access to client files and project materials. Due to the nature of our business, we have been remotely interacting with many of our international and local client companies for years, as our IT Department based our operational system on a fully digital platform.

Accordingly, we want to assure you that all ongoing and future projects will continue to be managed smoothly and expertly by our qualified consultants. If on-site support is required, we will look to provide it by using local, in country consultants in a safe and situation appropriate manner. At the same time, if we determine that on-site assignments can be handled remotely, we will work with our clients on the plan to best accomplish this.

Also, please note the US FDA and other international health agencies are considered essential government services and will continue to remain operational during this time. As many other agencies with contingency plans in place, FDA reviewers are able to work from home, remotely, to process various submissions. There may be occasional delays and extended timelines but the review process at the government agencies will go on. As for FDA on-site inspections, the FDA has presently put a hold on foreign inspections and we are seeing that inspections in the USA are being put on a hold as well. This seems to be on a case by case basis. We will keep you updated on any changes that we see as they occur.

As always, mdi Consultants are open to discuss any specific questions or concerns you may have with regards to your particular situation. Please reach out at [email protected] and we will be happy to assist.

Stay safe, remain calm and we will get through this together.