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
Edition # and Pub. Year.
SOP H/B Vol 11 - 2011
SOP H/B Vol 12 - 2012
SOP H/B Vol 13 - 2013
SOP H/B Vol 14 - 2014
SOP H/B Vol 15 - 2015
New Edition Annually
Handbook Generic Development
SOPs
& e-SOPs
A Three Part Development Handbook
Locum Press Edition International..
Volume 06 (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..
350+ e-SOPs™ in Word.rtf can be edited to meet your development
units own in-house needs. Designed for Generic and NDA pharma use. The+
deal includes 10 SOPs that IAGIM will write for your firm from an appropriate
email outline you create.
$1200 DISCOUNT VOUCHER INCLUDED - $35 per SOP
The three CD pack also includes a 60% discount voucher for an additional
30 SOPs IAGIM expert SOP writers will create for your department from
an email outline of the procedures (i.e. $75/SOP less $40 discount voucher
for each of the 30 SOPs)
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
are:
| Standard | Priority | Expedited.|
Price: Locum
International Catalog
Print - As advertised with - $300 discount TT voucher
Electronic in PDF - $300 discount TT voucher on 3 CDs
Electronic in Word.rtf (Editable version)
on 3 CDs - As advertised
 |
 |
| Ready-To-Go Link | Handbook Series | Journal Index | Specialized Journals |
