2009
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Regulatory Affairs


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

13 January, 2010
19:04 [RegAffairs]Climatic zone deepak jain
22:14 [RegAffairs]Re: Climatic zone Malcolm Ross
22:14 [RegAffairs]Re: Climatic zone Richard P Poska

14 January, 2010
07:42 [RegAffairs]Re: Climatic zone Surender Kumar
09:49 [RegAffairs]BE report No of CRF PAKHI RUSIA

15 January, 2010
07:14 [RegAffairs]Re: Climatic zone PharmWeb
11:07 [RegAffairs]Re: Climatic zone Brian MATTHEWS
11:12 [RegAffairs]Re: Climatic zone Malcolm Ross

16 January, 2010
09:30 [RegAffairs]Cosmetovigilance Report Luv Wadhwani
10:05 [RegAffairs]Re: Cosmetovigilance Report Muthiah Saravanan

18 January, 2010
09:52 [RegAffairs]Regulatory guidelines Brijesh Yadav
22:36 [RegAffairs]Re: Cosmetovigilance Report Lassoff, Peter
22:38 [RegAffairs]DMF Annual Reports Globepharm /Consulting

19 January, 2010
05:46 [RegAffairs]RE: DMF Annual Reports Ketan Agravat

27 January, 2010
16:49 [RegAffairs]Excipient clarity prasanna sagar

30 January, 2010
09:31 [RegAffairs]Regulatory Affairs Certificate vs. Master of Sciencein RA Luke

01 February, 2010
07:13 [RegAffairs]Site registration in Japan ivan piccoli
09:23 [RegAffairs]Re: Site registration in Japan Brian MATTHEWS

02 February, 2010
14:18 [RegAffairs]Re: BE report no of CRF shakeel
14:19 [RegAffairs]Re: site registration in Japan shakeel.salam

03 February, 2010
18:31 [RegAffairs]USP versus in-house API specification Kams
20:41 [RegAffairs]RE: USP versus in-house API specification Ketan Agravat
20:45 [RegAffairs]Re: USP versus in-house API specification Brian MATTHEWS
20:50 [RegAffairs]Re: Site registration in Japan Surender Kamal
20:51 [RegAffairs]Re: USP versus in-house API specification Malcolm Ross

04 February, 2010
06:54 [RegAffairs]Biowaiver for Iron Containing Product Surender Kamal

23 February, 2010
22:06 [RegAffairs]Query on stability studies Luv Wadhwani
22:06 [RegAffairs]API % Assay Calculation in Commercial Batch Anand G
22:57 [RegAffairs]Re: Query on stability studies Brian MATTHEWS

24 February, 2010
07:18 [RegAffairs]Re: Query on stability studies Malcolm Ross
07:23 [RegAffairs]Re: API % Assay Calculation in Commercial Batch Surender Kamal
07:33 [RegAffairs]Re: Query on stability studies Surender Kamal
07:33 [RegAffairs]Re: Query on stability studies aks
07:33 [RegAffairs]Re: Query on stability studies ge guo
07:34 [RegAffairs]Re: Query on stability studies Ranjith Gamage
07:39 [RegAffairs]Re: API % Assay Calculation in Commercial Batch Ranjith Gamage

11 March, 2010
11:10 [RegAffairs]Query on Microbiological Testing of Non-Sterile Drugproducts; Oral Solid Dosage Forms virgilio jun v villanueva

12 March, 2010
07:31 [RegAffairs]Re: Query on Microbiological Testing of Non-SterileDrug products; Oral Solid Dosage Forms Surender Kamal
08:20 [RegAffairs]Re: Query on Microbiological Testing of Non-SterileDrug products; Oral Solid Dosage Forms Meena Shah

17 March, 2010
10:10 [RegAffairs]US requirements for plastic bags intended for storageof APIs ybobinnec
11:33 [RegAffairs]Re: US requirements for plastic bags intended forstorage of APIs Surender Kamal

18 March, 2010
06:07 [RegAffairs]Re: API % Assay Calculation in Commercial Batch Frank W

24 March, 2010
10:50 [RegAffairs]Microbiology limit Sunil Durge

26 March, 2010
10:40 [RegAffairs]Re: Microbiology limit Brijesh Yadav
12:08 [RegAffairs]Reg Registration requirements in Brazil and Argentina Ashish Meher \(SRS\)

27 March, 2010
05:15 [RegAffairs]Re: Reg Registration requirements in Brazil andArgentina Surender Kamal
14:51 [RegAffairs]Listing of regulatory bodies Paul O'Hagan

28 March, 2010
09:03 [RegAffairs]U.S. FDA guidelines for Label and Package inserts Luv Wadhwani

29 March, 2010
08:11 [RegAffairs]Re: U.S. FDA guidelines for Label and Package inserts ge guo
08:16 [RegAffairs]RE: Listing of regulatory bodies r ramesh
08:18 [RegAffairs]Re: Listing of regulatory bodies Surender Kamal
08:21 [RegAffairs]RE: Listing of regulatory bodies Sreejith Kurup
08:21 [RegAffairs]RE: U.S. FDA guidelines for Label and Package inserts Sreejith Kurup
08:27 [RegAffairs]RE: U.S. FDA guidelines for Label and Package inserts KIRAN
12:52 [RegAffairs]SPL for package insert in original ANDA kiran

14 April, 2010
10:34 [RegAffairs]PET Testing Virender Kumar

15 April, 2010
11:41 [RegAffairs]Re: PET Testing Brijesh Yadav

16 April, 2010
06:33 [RegAffairs]Re: PET testing Luv Wadhwani
08:57 [RegAffairs]Re: PET testing Brian MATTHEWS
08:59 [RegAffairs]Re: PET Testing Surender Kamal
09:32 [RegAffairs]Re: PET Testing Brian MATTHEWS
12:40 [RegAffairs]Re: PET testing Steve Binysh

19 April, 2010
14:12 [RegAffairs]Reduce testing frequencies for real time stabilitystudies Dasari Srinivasa Rao
15:40 [RegAffairs]Re: Reduce testing frequencies for real timestability studies Brian MATTHEWS

21 April, 2010
18:36 [RegAffairs]Compliance with specification at the end of shelf life yves.bobinnec
19:25 [RegAffairs]Re: Compliance with specification at the end of shelflife Tudorache Luminita
23:53 [RegAffairs]Re: Compliance with specification at the end of shelflife Brian MATTHEWS

22 April, 2010
07:55 [RegAffairs]Re: Compliance with specification at the end of shelflife Surender Kamal
07:58 [RegAffairs]Re: Compliance with specification at the end of shelflife ge guo
08:20 [RegAffairs]Re: Compliance with specification at the end of shelflife AMIT JAIN
08:23 [RegAffairs]Re: Compliance with specification at the end of shelflife Muthiah Saravanan
09:02 [RegAffairs]RE: Compliance with specification at the end of shelflife Meena Shah

23 April, 2010
11:05 [RegAffairs]Re: Compliance with specification at the end ofshelflife Luv Wadhwani
11:07 [RegAffairs]Accommodating multiple indications on Product Insert(PIL) Anne Casey
12:45 [RegAffairs]Re: Compliance with specification at the end ofshelflife Brian MATTHEWS
12:47 [RegAffairs]Re: Accommodating multiple indications on ProductInsert (PIL) Brian MATTHEWS

27 April, 2010
12:35 [RegAffairs]Stability studies of products with Large Pack Size Luv Wadhwani
18:44 [RegAffairs]Re: Stability studies of products with Large Pack Size akkineni lakshmi
18:50 [RegAffairs]Re: Stability studies of products with Large Pack Size lt09

28 April, 2010
07:37 [RegAffairs]Re: Stability studies of products with Large Pack Size ge guo
10:08 [RegAffairs]Re: Stability studies of products with Large Pack Size Ranjith Gamage

03 May, 2010
11:53 [RegAffairs]CTD Romania query Brijesh Yadav

04 May, 2010
12:48 [RegAffairs]Re: CTD Romania query Tudorache Luminita

05 May, 2010
06:40 [RegAffairs]Re: CTD Romania query KIRAN
07:31 [RegAffairs]Re: CTD Romania query akkineni lakshmi

06 May, 2010
08:49 [RegAffairs]ANDA Section HETAL PATEL
10:08 [RegAffairs]Re: ANDA Section shaikim
10:18 [RegAffairs]RE: ANDA Section Meena Shah
10:20 [RegAffairs]RE: ANDA Section K. Harikishan
10:25 [RegAffairs]RE: ANDA Section KIRAN

07 May, 2010
10:21 [RegAffairs]Residual Solvent Ashok Suthar
10:26 [RegAffairs]Relaxation of LOD limit at granulation stage piyush
10:47 [RegAffairs]RE: Residual Solvent KIRAN
18:36 [RegAffairs]Re: Relaxation of LOD limit at granulation stage Richard P Poska
18:42 [RegAffairs]Re: Residual Solvent Surender Kamal

10 May, 2010
09:30 [RegAffairs]Re: ANDA Section shakeel

14 May, 2010
11:12 [RegAffairs]Requirements for clinical supply to Japan Anne Casey

17 May, 2010
07:30 [RegAffairs]Re: Requirements for clinical supply to Japan Surender Kamal

13 June, 2010
14:41 [RegAffairs]OTC Vs. Prescription products Luv Wadhwani

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