OTC Manufacturing
Regulated products with GMP rigor
Sunscreens, acne care, and therapeutic topicals produced under FDA registration, ISO 22716 GMP, and OTC controls.
Regulated Readiness
Controls designed for OTC requirements
We integrate formulation, testing, documentation, and release to meet stringent OTC expectations with clear traceability.
- Electronic batch records, line clearance, and deviation management.
- COA verification, quarantine, and retains for every lot.
- On-pack compliance and documentation packages for submissions.
OTC Capabilities
Therapeutic categories we support
Sun Care
SPF systems with stability, labeling, and compatibility checks for broad-spectrum performance.
Acne & Medicated
Benzoyl peroxide, salicylic acid, and sulfur pathways with safety and efficacy documentation.
Therapeutic Topicals
Analgesics, anti-itch, and other OTC categories aligned to FDA monographs.
Claims & Labeling
Drug Facts panel support, ingredient listings, and retailer documentation.
Testing & Release
Assay, identity, micro, stability, and retains with documented release criteria.
Packaging & Shipping
Component compatibility, leak testing, and transport simulation for regulated products.
Documentation
Traceability and audit readiness
- Batch records with weigh/dispense controls, yields, and cleaning logs.
- Label reconciliation, serialization options, and shipper verification.
- Retains tied to COA, micro, and stability data for each batch.
Packaging & Labels
OTC packaging designed for compliance
We verify component compatibility and labeling accuracy to keep launches compliant and on time.
- Leak, torque, and seal checks for tubes, bottles, and pumps.
- Drug Facts panel, lot/batch coding, and expiry labeling.
- Transportation simulation for DTC and retail distribution.
Request an OTC readiness review
Share formulas, actives, and launch timelines so we can map testing, documentation, and capacity.