505b2 For Drugs
We require an expert to assist with 505b2 for a drug/device combination.
We are repurposing an existing inhalation device coupled with a medical gas for home use. We plan to submit to the fda within 3-4 months and need help asap. We are looking for remote collaboration, thus location is of no importance. 505b2 has to be your core expertise.
Referrals are also welcomed, thank you.+undefined Other Responses
We are a small medical device company. I have a fda cleared device and i want to add an indication for which no predicate exists. Fda recommended de novo 510(k). I have engaged hogan lovells to manage this submission but i need someone to be our arms, legs, and mind to prepare for pre-sub fda meeting and assist in submission creation. I need a hands-on doer to do real work, not just someone to tell me what to do. This is an exciting new product that is making a difference in lives. It is ce marked and approved in many countries. We are based in gaithersburg maryland just north of washington, dc.+undefined Other Responses