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eCTDconsultancy - The Science Of Submissions

2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Join our mailing list. ECTDconsultancy: the Science of Submissions. ECTDconsultancy is software in...

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2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Join our mailing list. ECTDconsultancy: the Science of Submissions. ECTDconsultancy is software in...

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eCTDconsultancy - The Science Of Submissions | ectdconsultancy.com Reviews

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2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Join our mailing list. ECTDconsultancy: the Science of Submissions. ECTDconsultancy is software in...

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eCTDconsultancy eCTDconsultancy: the Science of Submissions

http://www.ectdconsultancy.com/content/ectd_consultancy_print.asp?cId=11

ECTDconsultancy: the Science of Submissions. ECTDconsultancy advises pharmaceutical and biotech companies on reducing time-to-submission by implementing strategies, processes and procedures related to scientific/strategic and operational aspects of drug development. We apply a scientific approach to working with Regulatory Submissions that ensures the highest possible quality of Regulatory Dossiers, with an ultimate aim of providing benefits to applicant, agency and patient. Advice for adapting software ...

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eCTDconsultancy - The Science Of Submissions

http://www.ectdconsultancy.com/content/ectd_consultancy_newsarchive.asp

2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Join our mailing list. The Common Electronic Submissions Gateway (CESG) is a method of . 03/12/201...

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eCTDconsultancy - The Science Of Submissions

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2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Home - eCTDconsultancy: the Science of Submissions. ECTD Strategy and Implementation.

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eCTDconsultancy - The Science Of Submissions

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Until recently, for each country or region, the information generated during drug development (i.e. study results, details of manufacture and legal/admin info) had to be documented in so-called regulatory dossier. This dossier was to be organized in accordance with country-specific national requirements and submitted for review by National Health Authorities. Read more. Submission Preparation and Management. Developed by Interactive Studios.

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eCTDconsultancy - The Science Of Submissions

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2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Join our mailing list. Register as a Trading Partner with Food and Drug Administration (FDA).

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Budding Regulatory Professionals: eCTD Tools

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This is track for Regulatory Professionals to discuss on Strategic planning, Pre-marketing, Post-marketing and Interfacing activities for Drugs (Innovator and Generics), Biological, Bio-similars, Medical devices. Globally identified Websites of Medicines Regulatory Authorities. 18 August 2014 at 01:15. Do you have any information solely on eCTD viewing tools? Subscribe to: Posts (Atom). TOPRA - Regulatory Rapporteur. Fundamentals of EU Drug Regulatory Affairs. API Requirements in EU.

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eCTDconsultancy - The Science Of Submissions

2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada. 26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone. REMINDER: EMA gateway made mandatory. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. 14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures. Join our mailing list. ECTDconsultancy: the Science of Submissions. ECTDconsultancy is software in...

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