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

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

Our new Formulation Suite has allowed us to expand our services further. Click here for a detailed look at our formulation 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

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)

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

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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