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TITLE 19 - HANDBOOK SERIES TITLE 21 - CMC Ready-To-Go Series



Title 21 Ready-To-Go Series

Contents of a Ready-To-Go CMC Dossier

FULL GENERIC DRUG CMC LIST - CLICK

TITLE 21 - CMC Ready-To-Go Series - Full or Abbreviated Versions

Full version Title 21 Ready-To-Go CMC Drug Development Know-how Series is available to Drug Development Association members or new membership only. Abbreviated available to non-members.

IAGIM Membership for The Title 21 Ready-To-Go CMC Drug Development Know-how Series is available to two year IAGIM members or via the many Extended Development Benefit Plans.
 
TITLE 21 - 120+ HANDBOOK SERIES - AN ALTERNATIVE COST APPROACH

ABBREVIATED e-Files
Non IAGIM members may purchase Title 21 Abbreviated Series, known under the collective title of the Handbook of Pharmaceutical Generic Development Series - Abbreviated Title 21 eFiles

ABBREVIATED VERSIONS
This Handbook Series (collectively known as the 'Abbreviated Title 21 Series') is an advanced drug development and plant production postgraduate level as a 'first look or sneek peek' preview but excludes the full length detailed aspects of drug development (including extensive Development Reports) for the specific target drug. Abbreviated Title 21 e-files reduce developers cost by 66% - 75% of full content print files.

FULL PRINT VERSIONS
The complete Handbooks are suitable as complete authoritative reference works for the particular target drug in question (whether Ziac, Tamoxifen, Nabumatone or other generics listed) and contain detailed chapters on the actual drug development as well as complete production CMC dossiers, suitable for immediate commercial production, similar to the database found at the commercial production level in the Tile 21 Ready-To-Go CMC Series.

 
DOWNLOAD the Ready-To-Go List (PDF Format)
IAGIM's full The Ready-To-Go CMC Drug Development Know-how Series List may be downloaded here.

PDF Format
 
Title 21 - DATA SPECIFICATIONS :
Title 21 R-T-Go Data knowhow package may be shipped in two separate ways:
Electronic CMC - Abbreviated [Title 21 by e-mail PDF - Abbreviated efiles]
Full Print versions of Title 21 (Available under licence on CD ROM up to 25 users)
 
 
Price in US $ (Product lists are simplified guides only)
Data Package for Single and Multiple Strength Drug Products are calculated on request. The displayed list prices are guides only and are based on the lowest number of strengths. Where multiple strengths occur the cost is increased proportionally.
Abbreviated Title 21 e-files reduce developers cost by 66% - 75% of full content print files
 
Price in US $ (Product lists are simplified guides only)
Immediate Release Tablets, Capsules Softgels & Suspensions etc.
Data Package for Single and Multiple Strength Drug Products are calculated on request. The displayed list prices are guides only and are based on the lowest number of strengths. Where multiple strengths occur the cost is increased proportionally.
Abbreviated Title 21 e-files reduce file cost by 66% - 75% of full content Print Files.
 
Controlled Release Tablets, Capsules
Data Package for Single or Multiple Strengths Drug Products are available
Complex Drugs (e.g. Paclitaxel Inj. 6mg/mL 30 & 100 mg vials - see product lists)
 
COPYRIGHT & INTELLECTUAL PROPERTY
Where IAGIM members are developing generic products for third parties who are not IAGIM members, then the primary IAGIM member (the developer) is required to enroll the third party as a secondary member for three years IAGIM membership subscription period. (Copyright & Intellectual Property Rule.)

Thus no third party may receive CMC IAGIM data without being a paid-up member. CMC products are not for resale or distribution and are shipped to registered IAGIM members in accordance with the registered address as stated on the IAGIM membership certificate.

NOTE:
EULA and IAGIM Rules & Regulations apply to Title 21 Ready-To-Go CMC Series.
Expedited shipping rates available


TITLE 21
READY-TO-GO CMC SERIES

FULL GENERIC DRUG DEVELOPMENT CMC LIST - CLICK

US CMC | EURO CMC | JAPAN CMC



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