Pharmaceuticals
We support prescription and OTC pharmaceutical products with a cost-effective approach from development through commercial production.
Built for global regulation
End-to-end quality in GMP execution
Prescription and OTC drug products require controlled GMP execution supported by defined procedures, ICH-aligned specifications, and a stability program matched to shelf life. We connect development, analytical testing, and manufacturing so batch documentation and quality oversight stay aligned as the project advances.
Technical alignment for scale‑up
Our approach is to align technical decisions with process control strategy early, then carry that discipline through manufacturing, testing, and batch release as the project scales.
QbD STRATEGY
CQAs, CPPs, and specifications defined to meet product requirements and lifecycle stages.
BATCH RECORDS, TESTING, AND RELEASE
Batch documentation, release testing, and review executed consistently to support timely release.
DEVIATIONS, CAPA, AND CHANGE CONTROL
Robust quality processes that support controlled evolution of the process and product over time.
QbD-driven lifecycle
We apply QbD principles to define critical quality attributes, establish an appropriate control strategy, and support ongoing process monitoring throughout the product lifecycle.
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.
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 DRUG PRODUCTS
Prescription drug products require disciplined development, defined controls, complete documentation, and Quality Unit oversight from development through commercial manufacturing.
-
Formulation development and product characterization to support 505(b)(1), 505(b)(2), ANDA, and other applicable regulatory pathways.
-
Scale-up, technology transfer, process validation, and specification-driven testing to support reliable GMP manufacturing and product release.
OTC DRUG PRODUCTS
OTC drug products require efficient development, disciplined GMP execution, and manufacturing strategies that balance product performance, regulatory requirements, and cost.
-
Formulation development and reference product assessment to support new products, reformulations, and competitive OTC programs.
-
Formulation and process optimization to improve stability, manufacturability, and product performance throughout the product lifecycle.
Our Services
Integrated services that move non-sterile prescription and OTC programs from development through batch release.
Product Development
Manufacturing-ready development that reduces rework later, with decisions that scale as requirements increase.
Analytical Services
Clear data for decision-making stability plans, and confident release as your program progresses.
Manufacturing & Packaging
Consistent execution designed for predictable release and routine supply, with controlled changes over time.
We support non-sterile prescription and OTC products with GMP execution, backed by strong analytical support and quality review.
Resources
Explore practical guidance for non-sterile prescription and OTC programs, from development through batch release.