OTC Pharmaceutical
Monograph compliance, formulation, stability, method development, and sterile/non‑sterile manufacturing under cGMP.
- Monograph & label review
- Analytical & release testing
- Packaging & shelf‑life studies
Science-first Contract Development & Manufacturing Organization
TG Labs partners with regulated brands to develop, validate, and manufacture high‑quality products across OTC Pharmaceutical, Dietary Supplements, Cosmetics, and Medical Devices.
Located in Centennial, Colorado, we bring your products from concept through development and production with multiple disciplines to meet your needs.
Monograph compliance, formulation, stability, method development, and sterile/non‑sterile manufacturing under cGMP.
Evidence‑based formulations, bioavailability strategies, and 21 CFR Part 111 compliant manufacturing and QC.
MoCRA‑aligned safety substantiation, micro control, and compliant labeling for premium skin & personal‑care.
ISO 13485‑oriented processes including sterilization coordination, validation, and lot‑traceable manufacturing.
Process design, DOE, and transfer from laboratory to pilot to commercial with robust CQA/CPP mapping.
Custom Mixing Resources →HPLC/GC/FTIR methods, verification/validation per USP/ICH, cleaning validation, and stability programs.
Training Materials →Risk‑based QMS aligned to 21 CFR Parts 210/211/111, ISO 13485, and MoCRA requirements.
Regulatory Guides →Our quality system emphasizes data integrity (ALCOA+), documented risk assessments, and traceability. Every lot is manufactured under written procedures with in‑process controls and release specifications.
Regulated brands, clinical innovators, and healthcare professionals seeking a pragmatic CDMO partner focused on quality, communication, and measurable outcomes.
Provide your project details and our technical team will respond with scope, regulatory considerations, timelines, and a costed proposal.
Secure project collaboration and file sharing for active clients.