2008
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171 Messages
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Regulatory Affairs
A. D'Emanuele
02 Jan
Seasons Greetings
akkineni lakshmi
27 Apr
[RegAffairs]Re: Stability studies of products with Large Pack Size
05 May
[RegAffairs]Re: CTD Romania query
aks
24 Feb
[RegAffairs]Re: Query on stability studies
AMIT JAIN
22 Apr
[RegAffairs]Re: Compliance with specification at the end of shelflife
08 Aug
[RegAffairs]Re: GMP/GLP certification in ANDA
Ana Matos
22 Jul
[RegAffairs]Developers information in EU MA submissionapplication form
Anand G
23 Feb
[RegAffairs]API % Assay Calculation in Commercial Batch
anil singh
01 Jul
[RegAffairs]Re: Problems with continuous manufacturing in pharma
16 Jul
[RegAffairs]Re: Inclusion of BD limits for API spec after DMFfiling
Anne Casey
23 Apr
[RegAffairs]Accommodating multiple indications on Product Insert(PIL)
14 May
[RegAffairs]Requirements for clinical supply to Japan
Aravind
10 Jul
[RegAffairs]RE: ANDA Stability Studies
Ashish Meher \(SRS\)
26 Mar
[RegAffairs]Reg Registration requirements in Brazil and Argentina
Ashok Suthar
07 May
[RegAffairs]Residual Solvent
14 Jun
[RegAffairs]Residual Solvent
atuL sakariya
13 Aug
[RegAffairs]Re: Japan Stability requirements for submission
Brian MATTHEWS
15 Jan
[RegAffairs]Re: Climatic zone
01 Feb
[RegAffairs]Re: Site registration in Japan
03 Feb
[RegAffairs]Re: USP versus in-house API specification
23 Feb
[RegAffairs]Re: Query on stability studies
16 Apr
[RegAffairs]Re: PET testing
16 Apr
[RegAffairs]Re: PET Testing
19 Apr
[RegAffairs]Re: Reduce testing frequencies for real timestability studies
21 Apr
[RegAffairs]Re: Compliance with specification at the end of shelflife
23 Apr
[RegAffairs]Re: Compliance with specification at the end ofshelflife
23 Apr
[RegAffairs]Re: Accommodating multiple indications on ProductInsert (PIL)
22 Jun
[RegAffairs]Re: Change in drying process- API
04 Jul
[RegAffairs]Re: Accelerated stability data of 3 months
12 Jul
[RegAffairs]Re: Kazakhstan / safety and risk management
22 Jul
[RegAffairs]Re: Developers information in EU MA submissionapplication form
02 Sep
[RegAffairs]Re: Physiological pH
Brijesh Yadav
18 Jan
[RegAffairs]Regulatory guidelines
26 Mar
[RegAffairs]Re: Microbiology limit
15 Apr
[RegAffairs]Re: PET Testing
03 May
[RegAffairs]CTD Romania query
16 Jun
[RegAffairs]Re: OTC Vs. Prescription products
23 Aug
[RegAffairs]Re: Excipients - TSE/BSE
chander kazipeta
11 Jul
[RegAffairs]Re: ANDA Stability Studies
08 Aug
[RegAffairs]Re: GMP/GLP certification in ANDA
Dasari Srinivasa Rao
19 Apr
[RegAffairs]Reduce testing frequencies for real time stabilitystudies
deepak jain
13 Jan
[RegAffairs]Climatic zone
22 Jun
[RegAffairs]Change in drying process- API
Frank W
18 Mar
[RegAffairs]Re: API % Assay Calculation in Commercial Batch
ge guo
24 Feb
[RegAffairs]Re: Query on stability studies
29 Mar
[RegAffairs]Re: U.S. FDA guidelines for Label and Package inserts
22 Apr
[RegAffairs]Re: Compliance with specification at the end of shelflife
28 Apr
[RegAffairs]Re: Stability studies of products with Large Pack Size
14 Jun
Re: [RegAffairs]OTC Vs. Prescription products
Globepharm /Consulting
18 Jan
[RegAffairs]DMF Annual Reports
Gopi Reddy
09 Aug
[RegAffairs]Re: GMP/GLP certification in ANDA
12 Aug
[RegAffairs]Re: Developers information in EU MA submissionapplication form
31 Aug
[RegAffairs]Re: Batch yield limit
HETAL PATEL
06 May
[RegAffairs]ANDA Section
Hiren Mehta
24 Aug
[RegAffairs]Re: GMP/GLP certification in ANDA
Ileana Rosales
30 Aug
[RegAffairs]Point to consider in Mass Spectrometry qualityassurance for biopharmaceutical characterization
ivan piccoli
01 Feb
[RegAffairs]Site registration in Japan
Jitendra Patel
03 Jul
[RegAffairs]Accelerated stability data of 3 months
12 Jul
[RegAffairs]Re: ANDA Stability Studies
K. Harikishan
06 May
[RegAffairs]RE: ANDA Section
Kams
03 Feb
[RegAffairs]USP versus in-house API specification
Ketan Agravat
19 Jan
[RegAffairs]RE: DMF Annual Reports
03 Feb
[RegAffairs]RE: USP versus in-house API specification
KIRAN
29 Mar
[RegAffairs]RE: U.S. FDA guidelines for Label and Package inserts
29 Mar
[RegAffairs]SPL for package insert in original ANDA
05 May
[RegAffairs]Re: CTD Romania query
06 May
[RegAffairs]RE: ANDA Section
07 May
[RegAffairs]RE: Residual Solvent
07 Aug
[RegAffairs]GMP/GLP certification in ANDA
11 Aug
[RegAffairs]Re: GMP/GLP certification in ANDA
12 Aug
[RegAffairs]Japan Stability requirements for submission
Lassoff, Peter
18 Jan
[RegAffairs]Re: Cosmetovigilance Report
13 Jun
[RegAffairs]Re: OTC Vs. Prescription products
lt09
27 Apr
[RegAffairs]Re: Stability studies of products with Large Pack Size
Luke
30 Jan
[RegAffairs]Regulatory Affairs Certificate vs. Master of Sciencein RA
Luv Wadhwani
16 Jan
[RegAffairs]Cosmetovigilance Report
23 Feb
[RegAffairs]Query on stability studies
28 Mar
[RegAffairs]U.S. FDA guidelines for Label and Package inserts
16 Apr
[RegAffairs]Re: PET testing
23 Apr
[RegAffairs]Re: Compliance with specification at the end ofshelflife
27 Apr
[RegAffairs]Stability studies of products with Large Pack Size
13 Jun
[RegAffairs]OTC Vs. Prescription products
22 Jun
[RegAffairs]Registration of Company in Afghanistan
25 Aug
[RegAffairs]Re: Excipients TSE/BSE
Malcolm Ross
13 Jan
[RegAffairs]Re: Climatic zone
15 Jan
[RegAffairs]Re: Climatic zone
03 Feb
[RegAffairs]Re: USP versus in-house API specification
24 Feb
[RegAffairs]Re: Query on stability studies
22 Jun
[RegAffairs]Re: Change in drying process- API
01 Jul
[RegAffairs]Re: Problems with continuous manufacturing in pharma
04 Jul
[RegAffairs]Re: Accelerated stability data of 3 months
07 Aug
[RegAffairs]Re: GMP/GLP certification in ANDA
22 Aug
[RegAffairs]Re: Excipients - TSE/BSE
23 Aug
Re: [RegAffairs]Re: Excipients - TSE/BSE
01 Sep
[RegAffairs]Re: Dissolution Development
Meena Shah
12 Mar
[RegAffairs]Re: Query on Microbiological Testing of Non-SterileDrug products; Oral Solid Dosage Forms
22 Apr
[RegAffairs]RE: Compliance with specification at the end of shelflife
06 May
[RegAffairs]RE: ANDA Section
Michael Anisfeld
13 Jun
[RegAffairs]Re: OTC Vs. Prescription products
14 Jun
[RegAffairs]Re: OTC Vs. Prescription products
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