Clinical Trial Manufacturing & Support
Small-batch, high-precision clinical supplies—built for speed, quality, and scalability.
Provides Support for Clinical Studies
Parimer Scientific supports investigational products from late preclinical through early clinical phases with flexible, right-sized operations.
Engagements commonly include:
GMP Small-Batch Manufacturing
Process development, tech transfer, scale-up for clinical trial materials (CTM).
Release & Stability
Specifications, release testing, ICH stability protocol design and execution, trending, and reporting.
Documentation & CMC
Batch records, CoAs, stability reports, and CMC sections to support IND/IMPD submissions.
Clinical Packaging & Labeling
Clinical kit assembly, labeling, and blinding services.
Analytical Services
Method development, impurity profiling, dissolution/EL, and stability-indicating methods.
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Storage & Distribution Coordination
Qualified storage, environmental monitoring, and lane planning with specialty couriers.
Development-to-Clinic
Process and analytical development through first clinical manufacture.
Manufacture-Only
Tech transfer of an established process for clinical lots.
Analytical & Stability-Only
Independent testing/studies supporting external manufacturing partners.
Quality & Compliance
Clinical work is performed under a phase-appropriate quality system aligned to GMP principles, with controlled documentation, change control, deviation/CAPA management, and supplier qualification. Study materials are traceable from incoming raw materials through finished clinical kits.
Looking for a reliable clinical manufacturing partner?
From process transfer to packaged clinical lots—on schedule and audit-ready.