JAPAN FORMAT

GENERIC DRUG DEVELOPMENT HANDBOOK 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 is available to three year IAGIM members or via the many Extended Development Benefit Plans.

GENERIC DRUG DEVELOPMENT HANDBOOK + 120 SERIES Non IAGIM members may purchase Title 19 Series, known 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 drug development and plant production postgraduate level and covers each and every aspect of drug development (including extensive Development Reports - FDA style) for the specific target drug. These Handbooks are suitable as complete authoritative reference works for the particular target drug in question (whether Tamoxifen or Nabumatone or other generics) 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.

COMPLETE USA DATA PACKAGE Handbook of Pharmaceutical Generic Development Series consistist of two parts Part One Drug Development Part Two ANDA Presentation and formulations / mfg. The two formats consist of the complete knowhow technological package.

DOWNLOAD the Ready-To-Go List (PDF Format) Handbook of Pharmaceutical Generic Development Series list may be downloaded at the click of a button. PDF Format

TECHNICAL LEVEL of USA DATA BASE US Data Base - based on US ANDA Database Requirements. EU Data Base - based on EU Dossier Requirements (Costs are separate from US). Product Lists show price per single strength - while double and triple or quadruple strength are calculated on request - as table is a simple guideline of values. Price in US $ or EU Euros (Product lists are simplified guides only) Immediate Release Tablets/Caplets, 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 EU files add additional 25 - 45% to price of US CMC Files   Controlled Release Tablets/Caplets, 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)   Title 21 - DATA SPECIFICATIONS : Electronic CMC - Abbreviated [Title 21 by e-mail PDF] - Expedited Level Only Electronic CD -Full quarterly updated data on CD ROM [Air shipped quarterly]   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 levels jump to first place in the shipping queue for an extra 15%

US HANDBOOK SERIES | EURO HANDBOOK SERIES | JAPAN HANDBOOK SERIES

TITLE 19
READY-TO-GO HANDBOOK SERIES
GENERIC DRUG DEVELOPMENT HANDBOOKS
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