2008
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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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