OTC Drug Regulatory Services

OTC Monograph Compliance Assessment (CARES Act Administrative Orders)

We evaluate your product against applicable OTC monographs and CARES Act orders to confirm it qualifies for OTC marketing.

Drug Facts Label Design & Review (21 CFR 201.66)

We design and review Drug Facts panels to ensure full compliance with FDA's format, content, and hierarchy requirements.

FDA Drug Establishment Registration & Listing (eDRLS)

We register your facility and list your drug products in FDA's eDRLS system to meet annual compliance deadlines.

cGMP Audit Preparation (21 CFR Parts 210 & 211)

We conduct mock inspections and documentation reviews to prepare your facility for FDA cGMP audits.

Sunscreen OTC Compliance (Final Rule)

We guide sunscreen manufacturers through FDA's final rule requirements, including SPF testing, labeling, and ingredient compliance.

Post-Market Compliance & Annual Reporting

We manage annual drug listing updates, track regulatory changes, and keep your OTC products in continuous compliance.