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

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

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