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March 23-26, 2026
New York City
QbD-driven lifecycle
We apply a QbD approach to define critical attributes, establish control strategy, and sustain GMP monitoring.
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DEFINE QTPP AND CQA
We define the Quality Target Product Profile (QTPP) and the Critical Quality Attributes (CQAs) that guide process development and decisions for clinical and commercial supply.
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PROCESS Parameters
We identify Critical Process Parameters (CPPs) and establish process controls, sampling plans, and procedures that keep manufacturing execution within validated ranges.
ANALYTICAL STRATEGY
We set release and stability specifications, including tests and acceptance criteria, and define an analytical strategy aligned with ICH expectations for drug product.
PROCESS VALIDATION
We support process validation across the lifecycle, including process design, PPQ, and continued process verification, to demonstrate consistent performance.
BATCH RECORDS
We generate GMP manufacturing batch records and execute Quality Unit review for disposition, supported by release testing performed against final specifications.
Our Capabilities
We develop and manufacture prescription and OTC drug products to meet market and regulatory requirements.
Prescription
Prescription products rely on defined controls, clear documentation, and Quality Unit oversight that supports consistent batch disposition across lifecycle stages.
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Formulation, reverse engineering, and comparative assessment to support 505(b)(2) and generic development decisions.
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Tech transfer, scale-up, and validation executed with specification-driven testing.
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OTC
OTC products benefit from GMP execution focused on efficient, cost‑effective manufacturing, helping clients meet pricing expectations and deliver compliant products to the market.
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Formulation, reverse engineering, and reference product benchmarking to guide OTC development and positioning.
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Formulation and process optimization support change control required for the product improvement or to meet stability targets, and manufacturability.
Our Services
Integrated services that move non-sterile prescription and OTC programs from development through batch release.
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Product Development
Turns target performance into a formulation and control strategy suitable for GMP scale-up and lifecycle changes.
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Analytical Services
Confirm product conformance through method validation and QC testing aligned to release and stability requirements.
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Manufacturing & Packaging
Deliver repeatable GMP batches using defined procedures, in-process controls, and Quality Unit review.