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TRIPHASE BROCHURE

"If an experiment does not hold out the possibility of causing one to revise one's views, it is hard to see why it should be done at all."

-Peter Medawar
1960 Nobel Laureate

"If you don't have time to do it right, when will you have time to do it over?"

-John Wooden
Basketball Coach

"It's the little details that are vital.  Little things make big things happen."

-John Wooden
Basketball Coach

"Intellectuals solve problems, geniuses prevent them."

-Albert Einstein

"Strive not to be a success, but rather to be of value."

-Albert Einstein

"The whole of science is nothing more than a refinement of everyday thinking."

-Albert Einstein

"Whoever is careless with the truth in small matters can not be trusted with important matters."

-Albert Einstein

"I start where the last man left off."

-Thomas A. Edison

"Hard work doesn't guarantee success, but improves its chances."

-Thomas A. Edison

"Success is dependent on effort"

-Sophocles (496-406)

"Show me a thoroughly satisfied man and I will show you a failure."

-Thomas A. Edison

"The three great essentials to achieve anything are hard work, stick-to-itiveness, and common sense."

-Thomas A. Edison

"What you are will show in what you do."

-Thomas A. Edison

"Opportunity is missed by most people because it is dressed in overalls and looks like work."

-Thomas A. Edison

"When one door closes, another opens; but we often look so long and so regretfully upon the closed door that we do not see the one that has opened for us."

-Alexander Graham Bell

"He who asks a question is a fool for five minutes; he who does not ask a question remains a fool forever."

-Chinese Proverb

"Let me tell you the secret that had led to my goals; my strength lies solely in my tenacity."

-Louis Pasteur

"Nobody is right all the time and even a broken clock is right two times a day."

-Bill Clinton on need to work together to solve problems DNC 2012

"Good science doesn't happen when people are keeping their heads down.  You need a raucous, rowdy discussion"

- Anonymous

"The great tragedy of Science is the slaying of a beautiful hypothesis by an ugly fact."

Thomas H. Huxley, "Biogenesis and Abiogenisis"

"Many consultants can 'turn the crank' but only few know 'when to crank, which crank to turn, which direction to crank, or how many turns."

- Anonymous

 

 

 

 

 

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:

  


Drug Substance

  • Complex synthesis; scope assessment, RFP preparation, and vendor selection

  • On-site and remote manufacturing oversight and batch releases

  • Off-shore API, starting material selection, intermediate sourcing

  • Cost of Goods calculations and “redesign” of synthetic routes to cut costs

  • Identifying raw materials sources and manufacturing sites 

  • Manufacturing GMP supplies for clinical studies 

  • Scale up and commercialization (from Phase 1 to NDA/post NDA supplies) 

Drug Product

  • Clinical trial materials GMP manufacture and release

  • Setting of specifications for drug product

  • Stability study design, problem solving

  • Analytical chemistry; assays and specifications, stability studies

  • Formulation of dosage forms (oral, injectable, topical, inhalation, drug-device combinations)

  • Scale up and commercialization 

Analytical / Impurities

  • Drug substance and drug product analytical method development and validation

  • Data analysis and setting raw material, API, and product specifications 

  • Genotoxin structure alert assessments; determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity

  • ICH Q3A impurity assessment and solving impurity issues

Outsourcing: Manufacturing, Analytical, and Stability

  • Directing drug substance and pharmaceutical drug product manufacturing at CMOs 

  • Act as scientific liaison with CMC contractors (API, formulation, manufacturing, analytical, clinical trial material packaging, assembly and distribution)

  • Man-in-the-Plant for critical CMC operations 

  • Technical management of contract manufacturing organizations (CMOs): Solve manufacturing problems to keep API programs on track

  • Technical Transfers: Monitoring production onsite to ensure success

  • Maintain a Quality Assurance role for virtual organizations

Quality Control / Regulatory Compliance / GMP Compliance

  • GMP Auditing of API and drug product manufacturers 

  • Project Management; science-driven oversight and coordination of CROs to ensure "on-time" delivery

  • Q7A, 21 CFR Parts 210-211 and ICH regulatory compliance 

  • Interpretation of FDA and international regulations and guidelines

  • Represent company at FDA or other regulatory agency meetings

  • Maintain Quality Assurance responsibilities for virtual companies (e.g., batch record review, release of clinical supplies)

  • CMC regulatory strategy; Phase 1 through commercial.  QA, QC reviews 

  • Drafting SOPs for emerging pharmaceutical and biotech organizations

  • Transfer of CMC knowledge and responsibilities to newly hired professional

  Regulatory Submissions

  • Primary CMC preparation, gap analysis, review and assessment of drug product development

  • Preparation of regulatory filings; Type II DMFs and CMC sections for IND, IMPD, NDA, ANDA in CTD format

  • Draft, write, review and/or compile CMC sections of IND, NDA, CTA, ANDA, DMF, CTD, eCTD format (Octagon, ISI) and other marketing applications

  • Write CMC sections of pre-IND, EOP2 and pre-NDA technical packages for meetings with FDA or other regulatory agencies

  • Write the P2 Pharmaceutical Development section of NDA applications

 
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 "TRIPHASE®" is a registered trade mark USPO serial number 77-964,084.  © 2010 TRIPHASE® Pharma Solutions, LLC. All Rights Reserved.

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