Consultants – Regulatory, Quality, Clinical and Medical
Consultants offer a great way to get high-level expertise.
But selecting the right consultant, qualifying them and insuring you remain in compliance with the law can be tricky and time consuming
Our consulting services can help.
We will find the best consultant for your particular needs based on industry, therapeutic expertise, cost and geography. We screen each consultant carefully looking for professional certifications, a good reputation and a commitment to finishing projects.
We also handle the paperwork for you. We take care of paying workers compensation and benefits for you, keeping you in compliance with California employment regulations.
Examples when you might want to use a high-level consultant:
You will need a qualified Regulatory Affairs professional to handle your IND and NDA applications. We find people who already have IND submission experience including pre-IND teleconference experience. This will help to insure your submission goes smoothly, your study is approved and not put on a clinical hold.
Whether you are still in pre-clinical studies or your product has launched, you need good Chemistry Manufacturing and Controls (CMC). Both IND and NDA submissions have sections on CMC that need to be submitted and the earlier improve your processes the less it will cost you in the long run.
If you need a GXP expert who can keep you in compliance we can help. Our CEO has been an active member of the American Society for Quality (ASQ) for nearly 25 years. This experience gives us insights into what is often said or not said on resumes. And we even have experts who can help you transition from the lab to the clinic and to high-scale manufacturing.
Regulations on food are being increased through the Food Safety and Modernization Act (FSMA). Once your company is on FDA’s radar screen it will stay there. We’ve been networking in this area since FSMA passed and know the industry experts who will keep you out of trouble. We can also partner a consultant with a Quality Control Apprentice to bring you into compliance and keep costs low.
Everyone will tell you they know how to write. But how well do they understand their audience, what to write, and what not to write? The cost to you of choosing a poor medical writer can mean a study being put on hold, a follow up study being required or even a warning letter from FDA. Rely on us to help you find a top medical writer with proven experience similar to your current needs.
Auditing is a great way to insure that your employees and suppliers are living up to their commitments. And nothing beats a fresh set of eyes to uncover mistakes that are being overlooked. Our auditors will also check that your Quality and Clinical employees properly trained. Better to uncover mistakes through a third-party auditor than to have them uncovered by an FDA inspector.