IAGIM - Drug Development Association

Available: Print

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

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

"..the best handbook money can buy today - Berk" / KRKA.

"Your truly unique and excellent series - Ranbaxy"

"very comprehensive indeed" - Biochemie

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

"The agency advised us to get your system - we did and our firm got our approval - Matrix / Sun / Dr Reddy / Dr Esteves SA Spain

"We use your SOP system - worldwide" - Perrigo

" 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

Vol, Edition # and Pub. Year.

H/B Vol 6/Ed 18 - 2018
H/B Vol 6/Ed 19 - 2019
H/B Vol 6/Ed 20 - 2020
H/B Vol 6/Ed 21 - 2021
H/B Vol 6/Ed 22 - 2022
H/B Vol 6/Ed 23 - 2023
H/B Vol 6/Ed 24 - 2024

New Updated Edition Annually

Handbook Generic Development
SOPs & e-SOPs

A Three Part Development Handbook

Locum Press Edition International.

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

Standard Print Edition.
Electronic Edition Standard Operating Procedures available in PDF or an editible Word.rtf format for in-house use.

Available in print or CD 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.

In summary IAGIM Expert SOP writers will create a SOP from a appropriate
draft email outline ('DEO') for a cost of $35ea to a maximum of 30 SOPs total .
Our motto is "give us a 'DEO' and we will send you in PDF and Word.rtf a polished completed SOP meeting all global agency requiremnts"

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.

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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