2007
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Regulatory Affairs


A. D'Emanuele
02 Jan Seasons Greetings

akkineni lakshmi
16 Sep [RegAffairs]Re: Analytical testing of SSP and SSC samples

aks
11 Mar [RegAffairs]Re: Holding time and mean kinetic temperature
13 Mar [RegAffairs]Re: Holding time and mean kinetic temperature
17 May [RegAffairs]Re: Same molecule, multiple strengths, multipleapplication nos.

Aleksandra
06 Mar [RegAffairs]Holding time and mean kinetic temperature
16 Mar [RegAffairs]Re: Holding Time and Kinetic Mean Temperature
12 Jul [RegAffairs]Dissolution test for GLIMEPIRIDE tablets
13 Jul [RegAffairs]Re: Dissolution test for GLIMEPIRIDE tablets

Anand.K
17 Oct [RegAffairs]Minimum Batch size for Liquids

Arun
15 May [RegAffairs]Multiple Regulatory clarifications

Bojan
02 Feb [RegAffairs]Neomycin and Bacitracin topical aerosol

Brian MATTHEWS
23 Feb [RegAffairs]Re: Mutual Recognition Procedure - TGA & EMEA
23 Feb [RegAffairs]Re: Mutual Recognition Procedure - TGA & EMEA
14 Mar [RegAffairs]Re: EU GMP certification
15 Mar [RegAffairs]Re: EU GMP certification
15 May [RegAffairs]Re: Multiple Regulatory clarifications

bruce berger
04 Jan [RegAffairs]Re: QC reporting to production

David
06 Oct [RegAffairs]The USP and the US FDA

David Lin
13 May [RegAffairs]Re: Same molecule, multiple strengths, multipleapplication nos.

Frank w
03 Apr [RegAffairs]Excipient DMF
14 Apr [RegAffairs]Re: Analytical method for unspecified & totalimpurities
30 Apr [RegAffairs]Re: Residual Levels of Methotrexate

Gerry Hara
26 Mar [RegAffairs]Reg Requirements for US shipping to Israel

Globepharm /MAnisfeld
03 Jan [RegAffairs]QC reporting to production
16 Jan [RegAffairs]UK Reg Affairs Professional Societies
03 Feb [RegAffairs]Re: Neomycin and Bacitracin topical aerosol
07 Feb [RegAffairs]Black eye for US Pharma Industry
12 May [RegAffairs]RE: Same molecule, multiple strengths, multipleapplication nos.
14 May [RegAffairs]Re: ppm
07 Oct [RegAffairs]Re: The USP and the US FDA

Hahn, Klaus
27 Feb [RegAffairs]Re: Mutual Recognition Procedure - TGA & EMEA

Hatice Atkaya
07 May [RegAffairs]Re: Same molecule, multiple strengths, multiple
07 May [RegAffairs]Data exclusivity
09 May [RegAffairs]I™LT : Data exclusivity

Ibtisam Freij
15 May [RegAffairs]Re: ppm

Jean-Denis Mallet
16 Jan [RegAffairs]Re: QC Reporting to Production

Jim Tyrrell
05 Jan [RegAffairs]Re: QC reporting to production
22 Feb [RegAffairs]Re: Mutual Recognition Procedure - TGA & EMEA
26 Feb [RegAffairs]Re: Mutual Recognition Procedure - TGA & EMEA
26 Feb [RegAffairs]Re: Mutual Recognition Procedure - TGA & EMEA
27 Feb [RegAffairs]Re: Mutual Recognition Procedure - TGA & EMEA
02 Mar [RegAffairs]Re: Submitting US dossier to EU
14 Mar [RegAffairs]Re: EU GMP certification

jmstyrrll@btinternet.com
02 Oct [RegAffairs]Re: Stability Study for Re-packing

kams
05 May [RegAffairs]Same molecule, multiple strengths, multipleapplication nos.
03 Oct [RegAffairs]Container Closure for Tablets ANDA

Kate
13 Mar [RegAffairs]Re: Holding time and mean kinetic temperature
17 Mar [RegAffairs]Re: Holding Time and Kinetic Mean Temperature

Ketan Agravat
16 Jan [RegAffairs]Re: QC reporting to production
14 Mar [RegAffairs]RE: EU GMP certification
15 Mar [RegAffairs]Re: EU GMP certification
15 Mar [RegAffairs]Re: EU GMP certification
09 Jun [RegAffairs]RE: Diastereoisomers as impurities
07 Oct [RegAffairs]Re: The USP and the US FDA

Kirti Rawal
14 Mar [RegAffairs]EU GMP certification
17 Mar [RegAffairs]Re: EU GMP certification
19 Jun [RegAffairs]Animal derived starting material

Lassoff, Peter
16 Jan [RegAffairs]RE: UK Reg Affairs Professional Societies
02 Mar [RegAffairs]Re: Submitting US dossier to EU
13 Mar [RegAffairs]Holding Time and Kinetic Mean Temperature
16 Mar [RegAffairs]Re: Holding Time and Kinetic Mean Temperature
07 Oct [RegAffairs]Re: The USP and the US FDA

Leanne Amitzi
21 Apr [RegAffairs]Methotrexate (MTX) in Cell Bank
29 Apr [RegAffairs]Residual Levels of Methotrexate
14 May [RegAffairs]ppm
10 Nov [RegAffairs]Osmolarity of Subcutaneous Injections

lee.bridgen
28 Apr [RegAffairs]Re: Labelling Requirement]
08 May [RegAffairs]Re: Data exclusivity

lt09
02 Mar [RegAffairs]Re: Submitting US dossier to EU
28 Apr [RegAffairs]Re: Labelling Requirement
17 Oct [RegAffairs]Re: Minimum Batch size for Liquids

Malcolm Ross
07 Feb [RegAffairs]Re: Black eye for US Pharma Industry
25 Feb [RegAffairs]Re: Mutual Recognition Procedure - TGA & EME
02 Mar [RegAffairs]Re: Submitting US dossier to EU
02 Mar [RegAffairs]Re: Sunset Clause in France
14 Mar [RegAffairs]Re: Holding Time and Kinetic Mean Temperature
26 Mar [RegAffairs]Re: Reg Requirements for US shipping to Israel
06 Apr [RegAffairs]Re: Excipient DMF
11 Apr [RegAffairs]Re: Analytical method for unspecified & totalimpurities
08 May [RegAffairs]Re: Data exclusivity
13 Jul [RegAffairs]Re: Dissolution test for GLIMEPIRIDE tablets
14 Jul [RegAffairs]Re: Dissolution test for GLIMEPIRIDE tablets
16 Sep [RegAffairs]Re: Analytical testing of SSP and SSC samples
16 Sep [RegAffairs]Re: Analytical testing of SSP and SSC samples

Nicola Nestor
26 Feb [RegAffairs]Sunset Clause in France

Nirav Chokshi
17 Oct [RegAffairs]Excipients' DMF
07 Nov [RegAffairs]Type IV DMF

NiravChokshi
03 Apr [RegAffairs]Re: Excipient DMF

PAKHI RUSIA
26 Mar [RegAffairs]Medication guide

palanivelu
17 Oct [RegAffairs]Re: Minimum Batch size for Liquids

PharmWeb
14 Nov [RegAffairs]Free conference for Representatives from DrugRegulatory Agencies, Royal Society, London.

prasanna sagar
05 Jul [RegAffairs]lyo load
16 Jul [RegAffairs]RLD in Injectables

rajamaniiyer
16 Sep [RegAffairs]Re: Analytical testing of SSP and SSC samples

rajaneesh B R
08 Mar [RegAffairs]Re: Labelling
10 Apr [RegAffairs]Analytical method for unspecified & total impurities
12 Apr [RegAffairs]RE:Analytical method for unspecified & totalimpurities

Rajaneesh.br
01 Mar [RegAffairs]Submitting US dossier to EU

ramasamy venkatasamy
14 Jul [RegAffairs]RE: DMF for Phase 1 IND

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