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TITLE 21 - CMC Ready-To-Go Series

Title 21 Ready-To-Go CMC Drug Development Know-how Series is available to Drug Development Association members or new membership only.
IAGIM Membership for The Title 21 Ready-To-Go CMC Drug Development Know-how Series runs for three consecutive years or available via the Extended Development Benefit Plans.

TITLE 19 - 120+ HANDBOOK SERIES

Non IAGIM members may purchase similar titles as tabulated below, under the collective title of the Handbook of Pharmaceutical Generic Development Series.
This Handbook Series (collectively known as the '120+ Series') is targeted at an advanced development and productions postgraduate level and covers each and every aspect of drug development for the specific target drug.

These Handbooks are suitable as complete authoritative reference works for the particular target drug in question (say Tamoxifen or Nabumatone), and also contain a chapter of complete production CMC dossiers, suitable for immediate production, similar to 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

DATA SPECIFICATIONS :

The Title 21 R-T-Go Data Know-how Package is shipped in two separate parts:

Electronic CMC - Abbreviated [Title 21 by e-mail PDF]

Electronic CD ROM - Update data on CD ROM [Title 21 quarterly airmail]

CDs with updated data are shipped during March, June, September and December.

Price in US $ (as per list)

Immediate Release Tablets, Capsules & Softgels; Suspensions etc.

Data Package for Single or Multiple Strength Drug Products are available

EU files add additional 20-25% to price of US CMC 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)

HOW TO MAKE PAYMENTS - 3 WAYS

Bank check

Credit card

Electronic Bank Transfer / Wire Transfer

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, Secondary Member for a 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. Multiple user license are required for multiple parties involved in the development or end product.

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

TITLE 21
READY-TO-GO CMC SERIES
FULL GENERIC DRUG DEVELOPMENT CMC LIST - CLICK

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