IAGIM - Drug Development Association
 
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Available: Print or CD
(Format PDF or Word.rtf)

Promotes the development and sharing of practical drug development knowledge and technology by agency and industry experts alike.

The world's most definitive & authoritative current generic drug development series available anywhere.

"Your truly unique and excellent series - Ranbaxy"

"very comprehensive indeed" - Biochemie

"All our departmental SOPs initially started from your excellent SOP system - and we simply built on the IAGIM structure" - Teva

" IVAX used your 3 SOP CD Set in Ireland and USA and we redid our analytical laboratories from A-Z IvaxNortons (prior to the TEVA aquisition)

" Our Tamoxifen 10/20/40mg was approved in record time in the UK and EU - based on your technology - Nortons Ir. (Now IVAX FL USA)

"The agency advised us to get your system - we did and our firm got US FDA agency approval - Matrix

"We use your SOP system - worldwide" - Perrigo

LOCUM INT. PRESS
Vol, Edition # and Pub. Year.

H/B Vol 6/Ed 14 - 2014
H/B Vol 6/Ed 15 - 2015
H/B Vol 6/Ed 16 - 2016
H/B Vol 6/Ed 17 - 2017
H/B Vol 6/Ed 18 - 2018
H/B Vol 6/Ed 19 - 2019
H/B Vol 6/Ed 20 - 2020

New Edition Annually

Handbook Generic Development
SOPs & e-SOPs
A Three Part Development To Final Production Handbook

Locum International Press


Volume 6 (Complete Handbook in Three Parts)
of the 24 Volume Drug Development Series.


Print + Electronic Standard Operating Procedures in PDF or Word.rtf (Editable)
Available in Print or two CD formats for immediate in-house use. Working examples provided on how to convert development SOPs into your own customised research-based-development system that meet all international regulatory guides, guidelines and regulatory requirements.

e-SOPs provide Development, Decision Trees, Formulation, Scale-up, Process Optimization & Qualification; pivotal and final large scale validation batches; analytical, cleaning and process validation; essential documentation and generic regulatory know-how that is essential for a successful product development and a speedy FDA approval, saving queue-time and development dollars.

Essential information for Development Pharmacists, R&D Chemists, QA and Regulatory personnel. Allows management to understand the nuts and bolts on Generic CTD/ANDA and EC Development and filing in the most cost effective way.

Readership
Development pharmacists, R&D chemists and scientists in pharmaceutical companies and university departments, in the areas of innovative, new drugs and generic drug development, QA / QC. validation and regulatory personnel.

Complete Volume in three parts 1790-1850 pp. Parts 1, 2 and 3 fully illustrated with diagrams, flow charts, graphs, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover) or via digital CD (multi-users require additinal optional license)
.

ISSN 0793 7641

All air shipping is 100% insured for loss or replacement. Shipping rates are: | Standard | Priority | Expedited.|

Price: Locum International Catalog



 

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