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Oral Solids
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Content Uniformity
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CDMO Services
Formulation Development
Oral Solids
Oral Liquids
Buccal
Topical
Injectables
Ophthalmic
Bioavailability Enhancement
Analytical Testing
ID & Assay
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Method Development & Validation
Content Uniformity
Dissolution Testing
Stability Storage & Testing
Clinical Supply Chain
Clinical Supply Management
cGMP Custom Synthesis
Clinical Supply Manufacturing
Clinical Packaging
Regulatory Services
505(b)(2) Strategy & Consulting
Pre-IND, IND, & NDA Services
IND, NDA, ANDA Writing & Filing
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GMP clinical batch manufacturing for Phase I and Phase II trials
GMP clinical batch manufacturing for Phase I and Phase II trials
HPLC analytical method development, validation, and testing
ICH temperature stability storage and testing
CMO selection, management, tech transfer, and troubleshooting
Pre-IND, IND, ANDA and NDA filing and document support, e-CTD publishing
IP creation and non-infringement strategizing
Consulting services for all stages of product development
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