2009

Regulatory Affairs

• Seasons Greetings, A. D'Emanuele
• [RegAffairs]Climatic zone, deepak jain
• [RegAffairs]Re: Climatic zone, Malcolm Ross
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Climatic zone, Richard P Poska
  • [RegAffairs]Re: Climatic zone, Surender Kumar
  • [RegAffairs]Re: Climatic zone, PharmWeb
  • [RegAffairs]Re: Climatic zone, Brian MATTHEWS
  • [RegAffairs]Re: Climatic zone, Malcolm Ross
• [RegAffairs]BE report No of CRF, PAKHI RUSIA
• [RegAffairs]Cosmetovigilance Report, Luv Wadhwani
• [RegAffairs]Re: Cosmetovigilance Report, Muthiah Saravanan
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Cosmetovigilance Report, Lassoff, Peter
• [RegAffairs]Regulatory guidelines, Brijesh Yadav
• [RegAffairs]DMF Annual Reports, Globepharm /Consulting
• [RegAffairs]RE: DMF Annual Reports, Ketan Agravat
• [RegAffairs]Excipient clarity, prasanna sagar
• [RegAffairs]Regulatory Affairs Certificate vs. Master of Sciencein RA, Luke
• [RegAffairs]Site registration in Japan, ivan piccoli
• [RegAffairs]Re: Site registration in Japan, Brian MATTHEWS
  • <Possible follow-up(s)>
  • [RegAffairs]Re: site registration in Japan, shakeel.salam
  • [RegAffairs]Re: Site registration in Japan, Surender Kamal
• [RegAffairs]Re: BE report no of CRF, shakeel
• [RegAffairs]USP versus in-house API specification, Kams
• [RegAffairs]RE: USP versus in-house API specification, Ketan Agravat
  • <Possible follow-up(s)>
  • [RegAffairs]Re: USP versus in-house API specification, Brian MATTHEWS
  • [RegAffairs]Re: USP versus in-house API specification, Malcolm Ross
• [RegAffairs]Biowaiver for Iron Containing Product, Surender Kamal
• [RegAffairs]Query on stability studies, Luv Wadhwani
• [RegAffairs]API % Assay Calculation in Commercial Batch, Anand G
• [RegAffairs]Re: Query on stability studies, Brian MATTHEWS
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Query on stability studies, Malcolm Ross
  • [RegAffairs]Re: Query on stability studies, Surender Kamal
  • [RegAffairs]Re: Query on stability studies, aks
  • [RegAffairs]Re: Query on stability studies, ge guo
  • [RegAffairs]Re: Query on stability studies, Ranjith Gamage
• [RegAffairs]Re: API % Assay Calculation in Commercial Batch, Surender Kamal
  • <Possible follow-up(s)>
  • [RegAffairs]Re: API % Assay Calculation in Commercial Batch, Ranjith Gamage
  • [RegAffairs]Re: API % Assay Calculation in Commercial Batch, Frank W
• [RegAffairs]Query on Microbiological Testing of Non-Sterile Drugproducts; Oral Solid Dosage Forms, virgilio jun v villanueva
• [RegAffairs]Re: Query on Microbiological Testing of Non-SterileDrug products; Oral Solid Dosage Forms, Surender Kamal
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Query on Microbiological Testing of Non-SterileDrug products; Oral Solid Dosage Forms, Meena Shah
• [RegAffairs]US requirements for plastic bags intended for storageof APIs, ybobinnec
• [RegAffairs]Re: US requirements for plastic bags intended forstorage of APIs, Surender Kamal
• [RegAffairs]Microbiology limit, Sunil Durge
• [RegAffairs]Re: Microbiology limit, Brijesh Yadav
• [RegAffairs]Reg Registration requirements in Brazil and Argentina, Ashish Meher \(SRS\)
• [RegAffairs]Re: Reg Registration requirements in Brazil andArgentina, Surender Kamal
• [RegAffairs]Listing of regulatory bodies, Paul O'Hagan
• [RegAffairs]U.S. FDA guidelines for Label and Package inserts, Luv Wadhwani
• [RegAffairs]Re: U.S. FDA guidelines for Label and Package inserts, ge guo
  • <Possible follow-up(s)>
  • [RegAffairs]RE: U.S. FDA guidelines for Label and Package inserts, Sreejith Kurup
  • [RegAffairs]RE: U.S. FDA guidelines for Label and Package inserts, KIRAN
• [RegAffairs]RE: Listing of regulatory bodies, r ramesh
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Listing of regulatory bodies, Surender Kamal
  • [RegAffairs]RE: Listing of regulatory bodies, Sreejith Kurup
• [RegAffairs]SPL for package insert in original ANDA, kiran
• [RegAffairs]PET Testing, Virender Kumar
• [RegAffairs]Re: PET Testing, Brijesh Yadav
  • <Possible follow-up(s)>
  • [RegAffairs]Re: PET testing, Luv Wadhwani
  • [RegAffairs]Re: PET testing, Brian MATTHEWS
  • [RegAffairs]Re: PET Testing, Surender Kamal
  • [RegAffairs]Re: PET Testing, Brian MATTHEWS
  • [RegAffairs]Re: PET testing, Steve Binysh
• [RegAffairs]Reduce testing frequencies for real time stabilitystudies, Dasari Srinivasa Rao
• [RegAffairs]Re: Reduce testing frequencies for real timestability studies, Brian MATTHEWS
• [RegAffairs]Compliance with specification at the end of shelf life, yves.bobinnec
• [RegAffairs]Re: Compliance with specification at the end of shelflife, Tudorache Luminita
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Compliance with specification at the end of shelflife, Brian MATTHEWS
  • [RegAffairs]Re: Compliance with specification at the end of shelflife, Surender Kamal
  • [RegAffairs]Re: Compliance with specification at the end of shelflife, ge guo
  • [RegAffairs]Re: Compliance with specification at the end of shelflife, AMIT JAIN
  • [RegAffairs]Re: Compliance with specification at the end of shelflife, Muthiah Saravanan
  • [RegAffairs]RE: Compliance with specification at the end of shelflife, Meena Shah
• [RegAffairs]Re: Compliance with specification at the end ofshelflife, Luv Wadhwani
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Compliance with specification at the end ofshelflife, Brian MATTHEWS
• [RegAffairs]Accommodating multiple indications on Product Insert(PIL), Anne Casey
• [RegAffairs]Re: Accommodating multiple indications on ProductInsert (PIL), Brian MATTHEWS
• [RegAffairs]Stability studies of products with Large Pack Size, Luv Wadhwani
• [RegAffairs]Re: Stability studies of products with Large Pack Size, akkineni lakshmi
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Stability studies of products with Large Pack Size, lt09
  • [RegAffairs]Re: Stability studies of products with Large Pack Size, ge guo
  • [RegAffairs]Re: Stability studies of products with Large Pack Size, Ranjith Gamage
• [RegAffairs]CTD Romania query, Brijesh Yadav
• [RegAffairs]Re: CTD Romania query, Tudorache Luminita
  • <Possible follow-up(s)>
  • [RegAffairs]Re: CTD Romania query, KIRAN
  • [RegAffairs]Re: CTD Romania query, akkineni lakshmi
• [RegAffairs]ANDA Section, HETAL PATEL
• [RegAffairs]Re: ANDA Section, shaikim
  • <Possible follow-up(s)>
  • [RegAffairs]RE: ANDA Section, Meena Shah
  • [RegAffairs]RE: ANDA Section, K. Harikishan
  • [RegAffairs]RE: ANDA Section, KIRAN
  • [RegAffairs]Re: ANDA Section, shakeel
• [RegAffairs]Residual Solvent, Ashok Suthar
  • <Possible follow-up(s)>
  • [RegAffairs]Residual Solvent, Ashok Suthar
• [RegAffairs]Relaxation of LOD limit at granulation stage, piyush
• [RegAffairs]RE: Residual Solvent, KIRAN
  • <Possible follow-up(s)>
  • [RegAffairs]Re: Residual Solvent, Surender Kamal
  • [RegAffairs]Re: Residual Solvent, Virender Kumar
• [RegAffairs]Re: Relaxation of LOD limit at granulation stage, Richard P Poska
• [RegAffairs]Requirements for clinical supply to Japan, Anne Casey