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
LOCUM INT. PRESS
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.
SOP WRITING DIVISION
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
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International Catalog
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