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.
I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...2.6 Hours Later
We might be able to assist you. We have helped others with their submissions. I have over 30 year...19.3 Hours Later
Prashant |Principal Consultant
I have done few projects with 505b2 let me know your interest Dr.Prashant Bodhe ...1.4 Days Later