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:

  • Process chemistry, Analytical Chemistry, and Formulation Development Laboratory

  • CRO/ CMO selection, contracts, and management with complete technical oversight

  • CMC regulatory chapters (IND, IMPD, NDA, MAA)

  • Quality Assurance oversight and sign off

  • Program timeline and budget management

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See our full list of instruments and equipment for an overview of our capabilities.

Preclinical

  • SAR synthetic strategy

  • Synthesis of SAR intermediates

  • Salt, Polymorph screening

  • Physiochemical Characterization

  • API Synthetic Route Evaluation

  • API Synthetic route Development (kg)

  • Analytical Chemistry

  • Formulation Development

  • Toxicology, Pharmacology studies

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Phase II

  • API Route scouting & Selection

  • API Route development (pilot scale)

  • PMF Development

  • Polymorph screening

  • Crystallization development

  • Specifications

  • Commercial Route Development (COGS)

  • Analytical Method Development (DS/DP)

  • Method validation (DS/DP, cGMP)

  • DS/DP release testing (cGMP)

  • DS/DP Stability (cGMP)

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Phase I

  • GMP API Synthesis (kg)

  • Analytical Method development (DS/DP)

  • Method Validation (DS/SP, cGMP)

  • DS/DP Release testing (cGMP)

  • DS/DP Stability (cGMP)

  • Pre-Formulation

  • Solid state characterization

  • Formulation Development

  • cGMP CTM Manufacture

  • IND (eIND) and IMPD

Phase III

  • Analytical Method Development (DS/DP)

  • Method validation (DS/SP, cGMP)

  • DS/DP Release testing (cGMP)

  • DS/DP Stability (cGMP)

  • PGI Method development

  • Impurity, Degradant, Metabolite ID

  • Impurity, Degradant, Metabolite synthesis

  • Reference Standards

  • Commercial Formulation

  • ANDA, NDA, and MAA

  • Drug Master File (DMF)

  • Marketing Applications

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5000 sq ft  R&D Laboratory​

  • Process Development​

  • Analytical Development ​

  • Formulation Development​

  • DS/DP Release Testing (cGMP)

Our Laboratory

© 2019 by Exemplify BioPharma

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