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TRIPHASE has drug product development
consulting and process development experience
enabling its clients to transition their products from
discovery to the clinic and to commercialization faster
and with less expense and risk. Whether your product is in
pre-clinical development, clinical trials, or already on
the market, we can help increase its value by identifying
opportunities for improving yield, product quality,
scalability, process robustness, cost savings, and
processing speed. Our expertise covers all aspects of CMC
(Chemistry, Manufacturing and Controls), including:
Process Development
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API Process
Development; new route design, process changes,
specifications
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Impurities,
crystallization, polymorph, salt forms, particle size,
milling
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Pre-formulation
and formulation development:
polymorph, salt form screening, selection,
scale-up
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Drug product process development
Analytical Development
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Analytical method development, qualification
and validation
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ICH
Q3A impurity assessment and solving impurity issues
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Phase-appropriate specification setting
strategies
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Stability studies
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Genotoxin
structure alert assessments; determining,
testing, and controlling specific impurities in
pharmaceuticals that possess potential for
genotoxicity
Manufacturing
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Drug substance and drug product clinical and
commercial manufacturing
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Product life-cycle management
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Process validation and validation master plans
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Technology transfer and scale-up
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Cost and process modeling, including new
technologies
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CMO Management
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Quality Systems and Regulatory
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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" "on-quality" and
"on-budget" 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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Maintain
a Quality Assurance role for virtual organizations
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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
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Facility
design
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Review
architect and building contractor plans for GMP
facility
GMP
Compliance Assessments and Audits
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Due
diligence audits of prospective CMC contractors
(qualification audits
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GMP
compliance assessments (of your organization or of CMC
contractors)
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Mock
FDA Pre Approval Inspections
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SOP
and Documentation assessment
Regulatory Submissions
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Creative concise scientific writing: Our CEO
is a published literary author as well as author of
over 30 scientific publications and patents. He
knows how to present your science concisely and in the
best light to support your goals gained from writing
over 50 regulatory filings including INDs, IBs, DMFs,
NDA, ANDAs.
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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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