FAQ

FAQ2017-03-03T22:02:55+00:00
If I am a foreign manufacturer do I need to follow FDA’s rules?2017-05-05T16:40:23+00:00

If you plan to market, sell, or distribute products in the United States you will need to follow the regulations set forth by US FDA. Additionally, you may need to follow specific regulations for clinical trials, laboratories, distributors, specification developers, etc. The type of product that you plan to import into the United States will determine the regulations that you will need to follow.

Can you help us with Non-FDA Inspections?2017-05-26T20:33:03+00:00

Yes, we work with agencies and notified bodies around the world. We work with clients to assist with inspections and product approvals in Japan, China, Brazil, Australia, and Europe. Furthermore, we strongly encourage clients to implement robust quality systems where a single set of procedures apply for all countries where the products are sold/distributed.

Could you do a fixed price project for me?2017-03-30T20:55:50+00:00

We could, be we seldom do. We believe that clients should only pay for the services that are actually rendered. Our preferred billing is based on time and materials. We do provide clients with a good faith project estimate and have worked with “not to exceed” orders based on PO amounts.

Can I get your help with our FDA response?2017-05-05T16:45:19+00:00

Yes, we would be happy to help. Some of our clients do not require long-term assistance or in-depth gap assessments, but they do need help responding to an FDA 483 or Warning Letter. We can help you prepare response letters, routine updates to the agency, recall correspondence, and other FDA correspondence.

Can you audit my CMO located in China? (India, Canada, Brazil, Costa Rica, Puerto Rico, Korea, Japan, Europe)2017-05-05T16:46:07+00:00

Yes, absolutely. We provide international support for our clients. We routinely perform quality audits and inspection readiness activities around the world. See our full service area here.

Do I need to pay extra for project management?2017-05-05T16:46:48+00:00

No. Project management, including the management of project schedules, budgets, tracking of consulting hours and expenses, are included with each project. Why pay more for something that should be a good practice?