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TRIPHASE
provides drug product development consulting services in the
area of initial synthesis of your lead NCE to execute key GLP studies.
We will manage
all aspects of your preclinical program required for
submission of a successful IND or CTA/IMPD. We
provide a full range of coordinated regulatory and
technical services including: |
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Drug
Substance
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Complex
synthesis;
scope assessment, RFP preparation, and
vendor selection
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Process
development; new route design, process changes,
specifications
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Impurities,
crystallization, polymorph, salt forms, particle size,
milling
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On-site
and remote manufacturing oversight and batch releases
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Off-shore
API, starting materials, intermediate sourcing
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IP
literature
and patent searches: CAS, CrossFire Data bases
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Cost
of Goods calculations and “redesign” of synthetic
routes to cut costs
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Identifying
raw materials sources and manufacturing sites
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Manufacturing
supplies for GLP and clinical studies
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Phase
appropriate specifications
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Characterization;
data analysis- HPLC, GC, Mass Spec, NMR, DSC, TGA, XRD
Drug Product
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Pre-formulation:
polymorph, salt form screening and selection,
scale-up
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In-vitro and
in-vivo equivalence testing
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Setting
of specifications
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Stability
study design, problem solving
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Analytical
chemistry; assays and specifications, stability
studies
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Formulation
of dosage forms (oral, injectable, topical,
ophthalmic, inhalation, drug-device combinations)
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Pre-formulation
studies to support effective formulation development
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Clinical
trial materials CRO identification and management
Development
Plans
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Define
comprehensive drug substance and formulation (CMC)
requirements based on toxicology and clinical
requirements and prepare Request for
Proposals (establish program
"scope of work").
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Identify
best CROs for your scientific needs and manage CROs as
required to ensure success.
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Incorporate
data and information into a final document in CTD
paper and/or electronic format.
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Provide
development plans suitable for inclusion in investor
meetings or proposals
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Write
development reports for inclusion in regulatory
submission
Analytical /
Impurities
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Drug
substance and drug product analytical method
development and validation
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Data
analysis and setting raw material, API, and product
specifications
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Genotoxin
structure alert assessments; determining,
testing, and controlling specific impurities in
pharmaceuticals that possess potential for
genotoxicity
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ICH
Q3A impurity assessment and solving impurity issues
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