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Regulatory Intelligence & Standards Team - Coggle Diagram
Regulatory Intelligence & Standards Team
Scope
In
Import/Export requirements
Should not be a limiting factor
How to convert CRM's to Standards
USP Partnership
How a RM/CRM is qualified to become a standard
External validation
Global regulatory agencies
Out
Commercial
L&D
Any items that could be used as a WOMD
Developing standards for global pharmacopeia
What does the future look like?
5 years
10 years
Documentary Standards
Compendial
USP
EP
JP
IP
WTO
Other Pharmacopeias
Voluntary Consensus Standards
ANSI
ISO
FDA Standards Recognition Program
Physical Standards
Compendial
Ongoing USP Parternship
New Submissions
CRM's
ATCC Catalog
Current products
Can be sold "as-is"
Upgrade to "CRM"
Expand STR
Potential New Products
Adventitious agents
Market Research
Global Regions
Asia & Asia-Pacific
India
Japan
Korea
Singapore
Taiwan
Europe
N. America
Latin America
Brazil
Mexico
Peru
Argentina
Chile
Regulatory Agencies
FDA
EPA
DEA
USDA
DOJ
DOC
Intern
US Agencies
Compendia
USP
EP
JP
IP
WTO
Other
Physical Vs Reference
Regulatory Intelligence Database
Agencies
Domestic
International
Preferred provider lists
Global Pharmacopeias
Regulatory Guidances
Other Biobanks and Biorepositories
Industry Groups
Education
Internal
Nomenclature
Standards
Quality
Goals
Develop Strategic Plan for Standards Development
Educate ATCC Staff
Have Regulatory Intelligence database
Opportunities
How good are they
Does it fit our current abilities
Measurements of Success
On preferred provider lists
Materials certified by various agencies
Increase in revenue
Establish/nurture relationships
Industry groups
Regulatory Agencies