IVD & DEVICE COMPLIANCE

OTC Drug

HMC supports over-the-counter (OTC) drug companies with FDA establishment registration, product listing and submission documentation, including structured product labeling (SPL). The applicable requirements depend on the product.

Service at a glance

Service at a glance
ItemDetails
ProviderHopkins MedTech Compliance
ForOTC drug companies
WorkRegistration, product listing and labeling documentation
Rules and standardsApplicable FDA drug registration and submission requirements
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Establishment registration, OTC drug product listing, NDC number, SPL authoring , self-identification GMP compliance, as well as other regulatory compliance related to drugs. This includes assistance for IND, NDA, ANDA, NADA, ANADA.

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