2005
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246 Messages
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Regulatory Affairs
Re: ISO vs GMP
,
Jay2rees
New EU legal framework for harmonisation of the data exclusivity
,
Zdravko Mauko, FARMAVITA
Seasons Greetings
,
A. D'Emanuele
time frame for DMF
,
Ashish
<Possible follow-up(s)>
time frame for DMF
,
Zdravko Mauko, FARMAVITA
Re: time frame for DMF
,
Ashish Mohan
Licensing and DMF
,
Ashish
Assistance with obtaining journal articles that appeared over 10 years ago
,
Michael Anisfeld
Re: Assistance with obtaining journal articles that appeared over 10 years ago
,
bruce berger
<Possible follow-up(s)>
Re: Assistance with obtaining journal articles that appeared over 10 years ago
,
Stanley110
Re: BE Injectables
,
Marcio.O.Silva
Authorized Generic
,
Naren
Biowaiver in Canada
,
Nisha K R
<Possible follow-up(s)>
Re: Biowaiver in Canada
,
gitarao
Data Exclusivity
,
Ashish
<Possible follow-up(s)>
RE: Data Exclusivity
,
Zdravko Mauko
Re: Data Exclusivity
,
Ashish NIPER
RE: Data Exclusivity
,
Steve Binysh
8+2+1 Data Exclusivity in EU
,
Zdravko Mauko, FARMAVITA
Data Exclusivity in USA
,
Zdravko Mauko, FARMAVITA
DMF holder can ?
,
Ashish NIPER
<Possible follow-up(s)>
RE: DMF holder can ?
,
Steve Binysh
RE: DMF holder can ?
,
Lassoff, Peter
RE: DMF holder can ?
,
Michael Anisfeld
RE: DMF holder can ?
,
Steve Binysh
RE: DMF holder can ?
,
Lassoff, Peter
Injectable Grade Regulatory Requirements
,
durgabp
<Possible follow-up(s)>
Re: Injectable Grade Regulatory Requirements
,
lt09
RE: Injectable Grade Regulatory Requirements
,
Michael Anisfeld
API GMPs: ICH-Q7A
,
Michael Anisfeld
<Possible follow-up(s)>
RE: API GMPs: ICH-Q7A
,
Peter Geffen
RE: API GMPs: ICH-Q7A
,
Michael Anisfeld
RE: API GMPs: ICH-Q7A
,
Lassoff, Peter
RE: API GMPs: ICH-Q7A
,
lt09
RE: API GMPs: ICH-Q7A
,
Lassoff, Peter
RE: API GMPs: ICH-Q7A
,
lt09
RE: API GMPs: ICH-Q7A
,
Michael Anisfeld
EU identification of packages
,
stein
rapid microbiology method for sterility testing
,
Nimrod
Generic applications via Centralised Procedure
,
Vincent Kuanyin Agoth Wek
<Possible follow-up(s)>
Re: Generic applications via Centralised Procedure
,
lt09
RE: Generic applications via Centralised Procedure
,
Steve Binysh
RE: Generic applications via Centralised Procedure
,
Lassoff, Peter
Re: Generic applications via Centralised Procedure
,
arvinda
re API GMPs: ICH-Q7A - Audit of Suppliers
,
Andrew Downing
Re: API GMP audit--Michael Ansfield Question
,
alanlongworth
Import of drugs to India
,
Jayram ramesh
Solution,Syrups and Suspension
,
yash wardhan
BA/BE across regulated markets
,
Nisha K R
CTD Module 1
,
Shalaka Mishra
<Possible follow-up(s)>
RE: CTD Module 1
,
Tim Felgate
Re: CTD Module 1
,
lt09
impurities in drug product.
,
A. D'Emanuele
<Possible follow-up(s)>
RE: impurities in drug product.
,
Steve Binysh
Regulatory Publications
,
Nisha K R
<Possible follow-up(s)>
RE: Regulatory Publications
,
Tim Felgate
Gamma Irradiation of API
,
Michael Anisfeld
OTC Monograph
,
thirumurugan gopalasamy
<Possible follow-up(s)>
Re: OTC Monograph
,
arvinda
API - Date of Manufacture
,
Michael Anisfeld
<Possible follow-up(s)>
Re: API - Date of Manufacture
,
Theodor Poettinger
RE: API - Date of Manufacture
,
snair
RE: API - Date of Manufacture
,
snair
RE: API - Date of Manufacture
,
Theodor Poettinger
RE: API - Date of Manufacture
,
Theodor Poettinger
RE: API - Date of Manufacture
,
snair
Re: API - Date of Manufacture
,
Brian MATTHEWS
RE: API - Date of Manufacture
,
Michael Anisfeld
Stability data 505(b)(2) NDA
,
Michael Beckert
Change of Servers this weekend
,
PharmWeb-Admin
RE: Sunscreen Products
,
David
<Possible follow-up(s)>
Sunscreen Products
,
Michael Anisfeld
RE: Sunscreen Products
,
Lassoff, Peter
RE: Sunscreen Products
,
Lassoff, Peter
RE: Sunscreen Products
,
Michael Anisfeld
RE: Sunscreen Products
,
bruce berger
RE: Sunscreen Products
,
Michael Anisfeld
Test methods of Inactive ingredients in ANDA
,
Nisha K R
<Possible follow-up(s)>
Re: Test methods of Inactive ingredients in ANDA
,
bruce berger
FDA inspection of foreign OTC manufacturing facilities
,
Bahirathan Mahesan
<Possible follow-up(s)>
Re: FDA inspection of foreign OTC manufacturing facilities
,
bruce berger
Process Validation
,
thirumurugan gopalasamy
Re: Impurity Qualification
,
arvinda
Bioeq CRO Inspection - Brazilian Legislation
,
Marcio.O.Silva
<Possible follow-up(s)>
Re: Bioeq CRO Inspection - Brazilian Legislation
,
Marcio.O.Silva
Batch Definitions
,
Michael Anisfeld
<Possible follow-up(s)>
RE: Batch Definitions
,
Steve Binysh
RE: Batch Definitions
,
Steve Binysh
API expiry question
,
Eden Venti
<Possible follow-up(s)>
Re: API expiry question
,
kuntal chatterjee
Re: API expiry question
,
Nisha K R
Re: API expiry question
,
Brian MATTHEWS
Re: API expiry question
,
Nisha K R
Re: API expiry question
,
Brian MATTHEWS
RE: API expiry question
,
Lassoff, Peter
ANDA Package insert related query
,
vardhini kirthivas
<Possible follow-up(s)>
RE: ANDA Package insert related query
,
Peter Rais
Re: ANDA Package insert related query
,
bruce berger
RE: ANDA Package insert related query
,
kalpana m dhumal
FDA Stability Guideline
,
Marcio.O.Silva
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