2008
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Regulatory Affairs


02 January, 2009
11:18 Seasons Greetings A. D'Emanuele

10 February, 2009
16:08 [RegAffairs]Proposal of Alternate Manufacturing Site-CANADA kams

16 February, 2009
06:01 [RegAffairs]Clinical Trials in Latin America Vardhini Kirthivas

17 February, 2009
08:47 [RegAffairs]Objectionable organisms Brian MATTHEWS

24 February, 2009
17:23 [RegAffairs]Regulatory Compliance Issues in PharmaceuticalOutsourcing prasanna

25 February, 2009
07:37 [RegAffairs]RE: Regulatory Compliance Issues in PharmaceuticalOutsourcing Ketan Agravat
10:18 [RegAffairs]New Drug Withdrawal prasanna
11:37 [RegAffairs]RE: New Drug Withdrawal Stein Lyftingsmo

26 February, 2009
09:05 [RegAffairs]Re: New Drug Withdrawal Malcolm Ross

05 March, 2009
12:18 [RegAffairs]Re: SUPAC guidelines for Europe Malcolm Ross
12:50 [RegAffairs]SUPAC guidelines for Europe akkineni lakshmi
16:54 [RegAffairs]Re: SUPAC guidelines for Europe Steve Binysh (business)
17:56 [RegAffairs]RE: SUPAC guidelines for Europe ramasamy venkatasamy
17:57 [RegAffairs]Re: SUPAC guidelines for Europe Brian Matthews

08 April, 2009
07:02 [RegAffairs]Manufacturing license in EU countries akkineni lakshmi
09:22 Re: [RegAffairs]Manufacturing license in EU countries Brian MATTHEWS
10:36 [RegAffairs]Re: Manufacturing license in EU countries Tim Felgate
13:51 [RegAffairs]Re: Manufacturing license in EU countries akkineni lakshmi
13:51 [RegAffairs]Re: Manufacturing license in EU countries Bfn

09 April, 2009
07:01 [RegAffairs]Safety Assessment Maria Ines Harris
09:47 [RegAffairs]Re: Safety Assessment Adriaan Fruijtier
14:54 [RegAffairs]Re: EU supac shakeel

25 April, 2009
13:11 [RegAffairs]Japan DMF & Dossier filing Yoganantham A [ Regulatory Affairs ]
14:30 [RegAffairs]Re: Japan DMF & Dossier filing Brian MATTHEWS

27 April, 2009
06:22 [RegAffairs]Re:Japan DMF & Dossier filing B.Anil Kumar Singh

28 April, 2009
08:24 [RegAffairs]Re: Japan DMF & Dossier filing shakeel.salam

04 May, 2009
09:22 [RegAffairs]Change in API source prasanna sagar
12:07 [RegAffairs]Re: Change in API source Brian MATTHEWS
12:35 [RegAffairs]Re: Change in API source Globepharm /Consulting

05 May, 2009
08:13 [RegAffairs]Stability studies for ANDA submission Harikishan
09:15 [RegAffairs]Ophthalmic formulations: Drop size requirement Harikishan
13:33 [RegAffairs]Re: Stability studies for ANDA submission shakeel
13:34 [RegAffairs]RE: Stability studies for ANDA submission Aravind
16:24 [RegAffairs]RE: Ophthalmic formulations: Drop size requirement Steve Binysh

06 May, 2009
09:06 [RegAffairs]ANVISA - OTC Registration Requirements Harikishan
10:21 [RegAffairs]RE: Change in API source Aravind
14:17 [RegAffairs]Re: ANVISA - OTC Registration Requirements Maria Ines Harris

12 May, 2009
08:26 [RegAffairs]Re: ANVISA - OTC Registration Requirements Harikishan
12:04 [RegAffairs]CEP source and Test method Kams
13:14 [RegAffairs]FDA inquiry Bojan Pavlovic

15 May, 2009
18:32 [RegAffairs]Polymorphism mei azhakan

16 May, 2009
07:39 [RegAffairs]Re: Polymorphism N.Sumithra
10:37 [RegAffairs]Re: Polymorphism B.Anil Kumar Singh
20:27 [RegAffairs]Re: FDA inquiry Globepharm /MAnisfeld

18 May, 2009
08:47 [RegAffairs]First Three Validation Batches for US Market NIRAV CHOKSHI
17:46 [RegAffairs]RE: First Three Validation Batches for US Market Globepharm /MAnisfeld
18:30 [RegAffairs]Re: First Three Validation Batches for US Market cgmpman

27 May, 2009
09:19 [RegAffairs]SOP anandgd
10:18 [RegAffairs]Clinical Trial Prasoon Mishra
11:24 [RegAffairs]Re: Clinical Trial lt09
12:28 [RegAffairs]Re: Clinical Trial Tim Felgate

29 May, 2009
16:59 [RegAffairs]Outsourcing of technical services and regulatoryrequirements L Watson

01 June, 2009
05:41 [RegAffairs]EU GMP certification Praveen Kumar
09:14 [RegAffairs]Re: EU GMP certification B.Anil Kumar Singh
10:18 [RegAffairs]Re: EU GMP certification Ketan Agravat
13:27 [RegAffairs]Re: EU GMP certification Sharma, Lalit
17:00 [RegAffairs]Re: EU GMP certification lt09

02 June, 2009
07:13 [RegAffairs]Waiver for bioequivalence - ophthalmic products Harikishan

04 June, 2009
11:40 [RegAffairs]Puerto Rico Guidelines shakeel.salam
19:23 [RegAffairs]Re: Puerto Rico Guidelines Globepharm /MAnisfeld

05 June, 2009
22:15 [RegAffairs]How to export nutritional Supplements to EU ? Michal Kranc

07 June, 2009
09:05 [RegAffairs]Re: How to export nutritional Supplements to EU ? Steve Binysh
12:45 [RegAffairs]Re: How to export nutritional Supplements to EU ? Wanda Jay
19:00 [RegAffairs]Stability testing Stein
20:25 [RegAffairs]RE: Stability testing Rivka Zaibel
22:02 [RegAffairs]RE: Stability testing Lassoff, Peter
22:02 [RegAffairs]RE: Stability testing Steve Binysh

08 June, 2009
15:31 [RegAffairs]RE: Stability testing Peter Geffen

14 June, 2009
16:22 [RegAffairs]Re: ANVISA - OTC Registration Requirements Maria Ines Harris

20 June, 2009
10:01 [RegAffairs]Re: stability indicating method rajamaniiyer
10:19 [RegAffairs]stability indicating method saravanan
13:07 [RegAffairs]Re: Stability indicating method Jim Tyrrell
22:07 [RegAffairs]Re: stability indicating method Malcolm Ross

22 June, 2009
10:33 [RegAffairs]RE: stability indicating method Sreejith Kurup

13 July, 2009
09:17 [RegAffairs]Microbial testing frequency for solutions akkineni lakshmi
18:21 [RegAffairs]Residual Metal Catalyst harshath
18:21 [RegAffairs]Polymorphism Mei
21:15 [RegAffairs]Re: Polymorphism Malcolm Ross

18 July, 2009
12:41 Re: [RegAffairs]Polymorphism Muthiah Saravanan

21 July, 2009
12:41 [RegAffairs]Stability - Assay Parameter Jain
13:43 [RegAffairs]Re: Stability - Assay Parameter Muthiah Saravanan
14:43 [RegAffairs]Re: Stability - Assay Parameter Ranjith Gamage
15:01 [RegAffairs]Re: Stability - Assay Parameter Malcolm Ross
15:15 [RegAffairs]Re: Stability - Assay Parameter Brian MATTHEWS
15:59 [RegAffairs]Recreating clinical data Malcolm Ross
16:45 [RegAffairs]RE: Recreating clinical data Lassoff, Peter
18:28 [RegAffairs]Re: Recreating clinical data Vincent Wek
18:33 [RegAffairs]Re: Recreating clinical data Steve Binysh (business)
20:14 [RegAffairs]Re: Recreating clinical data Malcolm Ross

22 July, 2009
06:44 [RegAffairs]Re: Recreating clinical data Steve Binysh (business)

23 July, 2009
21:18 [RegAffairs]Expiry or provisional expiry Kalpana Pandey

24 July, 2009
07:42 [RegAffairs]RE: Expiry or provisional expiry akkineni lakshmi
08:42 [RegAffairs]Re: Expiry or provisional expiry Muthiah Saravanan
18:49 [RegAffairs]Re: Expiry or provisional expiry Malcolm Ross
18:49 [RegAffairs]Re: Stability - Assay Parameter Kams
18:49 [RegAffairs]Re: Expiry or provisional expiry Sharma, Lalit
19:49 [RegAffairs]osmolarity as IP test prasanna sagar
19:49 [RegAffairs]Re: Expiry or provisional expiry Steve Binysh (business)
19:53 [RegAffairs]Re: Expiry or provisional expiry VISHAL
22:25 [RegAffairs]Re: Expiry or provisional expiry Brian MATTHEWS

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