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TRIPHASE
provides drug product development consulting services in the
area of
manufacturing
of GMP clinical trial materials for Phase 1 and Phase 2 proof of concept (POC) studies. 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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On-site
and remote manufacturing oversight and batch releases
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Off-shore
API, starting material selection, intermediate sourcing
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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
GMP supplies for clinical studies
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Scale
up and commercialization (from Phase 1 to NDA/post NDA
supplies)
Drug Product
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Clinical
trial materials GMP manufacture and release
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Setting
of specifications for drug product
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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,
inhalation, drug-device combinations)
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Scale
up and commercialization
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
Outsourcing:
Manufacturing, Analytical, and Stability
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Directing
drug substance and pharmaceutical drug product
manufacturing at CMOs
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Act
as scientific liaison with CMC contractors (API,
formulation, manufacturing, analytical, clinical trial
material packaging, assembly and distribution)
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Man-in-the-Plant
for critical CMC operations
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Technical
management of contract manufacturing organizations (CMOs):
Solve manufacturing problems to keep API programs on
track
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Technical
Transfers: Monitoring production onsite to ensure
success
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Maintain
a Quality Assurance role for virtual organizations
Quality Control / Regulatory
Compliance / GMP Compliance
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GMP
Auditing of API and drug product manufacturers
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Project
Management;
science-driven oversight and coordination of CROs
to
ensure "on-time" delivery
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Q7A, 21 CFR
Parts 210-211 and ICH regulatory compliance
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Interpretation
of FDA and international regulations and guidelines
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Represent
company at FDA or other regulatory agency meetings
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Maintain
Quality Assurance responsibilities for virtual
companies (e.g., batch record review, release of
clinical supplies)
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CMC
regulatory strategy;
Phase 1 through commercial.
QA, QC reviews
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Drafting
SOPs for emerging pharmaceutical and biotech
organizations
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Transfer
of CMC knowledge and responsibilities to newly hired
professional
Regulatory Submissions
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Primary
CMC preparation, gap analysis, review and assessment
of drug product development
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Preparation
of regulatory filings;
Type II DMFs and CMC sections for IND, IMPD, NDA, ANDA
in CTD format
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Draft,
write, review and/or compile CMC sections of IND, NDA,
CTA, ANDA, DMF, CTD, eCTD format (Octagon, ISI) and
other marketing applications
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Write
CMC sections of pre-IND, EOP2 and pre-NDA technical
packages for meetings with FDA or other regulatory
agencies
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Write
the P2 Pharmaceutical Development section of NDA
applications
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