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  • FDA Labeling Review and Obtaining A NDC#

    $50/hr Starting at $25 Ongoing

    Dedicated Resource

    If you are small manufacture or private labeler distributor who needs help to get NDC# (National Drug Code) for OTC Monograph products in USA, I will prepare and send electronic submission (SPL) for you...

About

FDA Regulatory Labeling Review, Obtaining A NDC Number and Product assessment

Originally I am from Russia. I have MD in engineer physicist ballistics. I worked as a programmer and computer science lecture (more than 10 years). I have more 10 years of experience in Regulatory Affairs (topical OTC monograph products). I am offering my help with electronic establishment registrations and drug listings including the submission of SPL via ESG/CDER. Also I have 10 years experience to review labeling OTC products to comply with 21 CFR 200-300 and can help to register your product with Florida Health Department.

Work Terms

To obtain NDC# - $200
To obtain Labeler Code & NDC# - $300
To register facility, obtain Labeler Code & NDC# -$400
Labeling review drug&cosmetic products - $50/h