API synthesis through finished dosage form—solid, sterile, and liquid—under GMP-validated conditions at every batch scale. Self-qualify against your compound’s requirements below.
Multi-step organic synthesis, chiral chemistry, controlled substance scheduling (Schedule I–V DEA registration), and high-potency API handling in dedicated suites. Batch records issued per ICH Q7.
Oral solid (tablets, capsules, granules), sterile injectable (vials, lyophilized), and oral liquid (solutions, suspensions). Each form validated under 21 CFR Part 211 and USP general chapters.
Gram-level development batches through 500 kg commercial production. Scale-up protocols are documented at each stage; first-time yield data available on request.
Development batches establish process parameters. Tech transfer protocols lock them. Each scale step requires documented validation—no assumptions carry forward without data.
Batch records issued at every scale: gram, kilogram, and commercial. Deviations are documented, root-caused, and closed before the next run proceeds.
Direct compression, wet granulation, film coating, and encapsulation. Hardness, dissolution, and content-uniformity testing per USP specification on every batch.
ISO 5 fill-finish suites, lyophilization capability, and 100% particulate inspection. Aseptic process validation per FDA Guidance for Industry and Annex 1.
Solutions and suspensions in tank sizes from 50 L to 5,000 L. pH, viscosity, and assay testing documented per batch record before release to fill.
Manufactured to specification. Documented to audit.