OUR
SERVICES
Exemplify BioPharma
We are a global Partnership Research Organization (PRO) that offers end-to-end CMC deliverable through our unique "under one roof" strategy. We offer integrated project management through:
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Process chemistry, Analytical Chemistry, and Formulation Development Laboratory
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CRO/ CMO selection, contracts, and management with complete technical oversight
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CMC regulatory chapters (IND, IMPD, NDA, MAA)
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Quality Assurance oversight and sign off
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Program timeline and budget management
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See our full list of instruments and equipment for an overview of our capabilities.
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Our new Formulation Suite has allowed us to expand our services further. Click here for a detailed look at our formulation capabilities.
Preclinical
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SAR synthetic strategy
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Synthesis of SAR intermediates
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Salt, Polymorph screening
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Physiochemical Characterization
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API Synthetic Route Evaluation
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API Synthetic route Development (kg)
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Analytical Chemistry
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Formulation Development
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Toxicology, Pharmacology studies
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Phase II
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API Route scouting & Selection
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API Route development (pilot scale)
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PMF Development
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Polymorph screening
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Crystallization development
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Specifications
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Commercial Route Development (COGS)
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Analytical Method Development (DS/DP)
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Method validation (DS/DP, cGMP)
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DS/DP release testing (cGMP)
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DS/DP Stability (cGMP)
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Phase I
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GMP API Synthesis (kg)
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Analytical Method development (DS/DP)
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Method Validation (DS/SP, cGMP)
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DS/DP Release testing (cGMP)
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DS/DP Stability (cGMP)
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Pre-Formulation
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Solid state characterization
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Formulation Development
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cGMP CTM Manufacture
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IND (eIND) and IMPD
Phase III
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Analytical Method Development (DS/DP)
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Method validation (DS/SP, cGMP)
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DS/DP Release testing (cGMP)
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DS/DP Stability (cGMP)
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PGI Method development
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Impurity, Degradant, Metabolite ID
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Impurity, Degradant, Metabolite synthesis
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Reference Standards
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Commercial Formulation
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ANDA, NDA, and MAA
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Drug Master File (DMF)
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Marketing Applications
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18,500 sq ft R&D Laboratory​
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Process Development​
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Analytical Development ​
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Formulation Development​
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DS/DP Release Testing (cGMP)
Our Laboratory
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