Regulated Pharmaceuticals

Pharmaceutical testing, potency, dissolution, stability studies, raw materials, method development, and regulatory submissions.

6 services

Available Services

HPLC Analysis

High-Performance Liquid Chromatography for potency, impurity profiling, and assay in pharmaceutical products.

5-10 days
$300-$1,500
ISO 17025

Dissolution Testing

Drug release rate and extent from solid dosage forms per USP apparatus.

5-10 days
$400-$2,000
ISO 17025

Stability Studies

ICH-compliant accelerated and long-term stability for shelf life and storage conditions.

1-12 months
$2,000-$15,000
ISO 17025, GMP

Raw Material Testing

Identity, purity, and quality of pharmaceutical raw materials and excipients per USP/EP.

3-7 days
$200-$800
ISO 17025

Analytical Method Development

Custom method development and ICH Q2 validation for new drug substances and formulations.

2-8 weeks
$5,000-$25,000
ISO 17025, GMP

Regulatory Submission Support

IND/NDA/ANDA support, eCTD preparation, and FDA meeting preparation for drug applications.

Project-based
$15,000-$150,000

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