apexregulatory.blogspot.com apexregulatory.blogspot.com

apexregulatory.blogspot.com

Apex Regulatory's Blog

Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Saturday, June 29, 2013. EU eCTD Specification 2.0 - Are You Prepared? Implementation of the Module 1 EU Specification update from Version 1.4.1 to Version 2.0 becomes mandatory. How Will the Updates Affect Me? I was recently in contact with someone who was unsure whether the changes to Module 1 would affect their company at all. The bot...

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Apex Regulatory's Blog | apexregulatory.blogspot.com Reviews
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Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Saturday, June 29, 2013. EU eCTD Specification 2.0 - Are You Prepared? Implementation of the Module 1 EU Specification update from Version 1.4.1 to Version 2.0 becomes mandatory. How Will the Updates Affect Me? I was recently in contact with someone who was unsure whether the changes to Module 1 would affect their company at all. The bot...
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Apex Regulatory's Blog | apexregulatory.blogspot.com Reviews

https://apexregulatory.blogspot.com

Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Saturday, June 29, 2013. EU eCTD Specification 2.0 - Are You Prepared? Implementation of the Module 1 EU Specification update from Version 1.4.1 to Version 2.0 becomes mandatory. How Will the Updates Affect Me? I was recently in contact with someone who was unsure whether the changes to Module 1 would affect their company at all. The bot...

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apexregulatory.blogspot.com apexregulatory.blogspot.com
1

Apex Regulatory's Blog: Preparing Documents for Submission

http://apexregulatory.blogspot.com/2011/07/preparing-documents-for-submission.html

Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Wednesday, July 13, 2011. Preparing Documents for Submission. The preparation of documents for submission in CTD format can be a time consuming and arduous task. Your document authors should be well aware of the restrictions and requirements for such documents, and take care to ensure that their output remains compliant. Flexibility, you...

2

Apex Regulatory's Blog: August 2011

http://apexregulatory.blogspot.com/2011_08_01_archive.html

Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Thursday, August 18, 2011. PDF Hyperlinking within the eCTD. ECTD Validation Criteria v3.0 (which will come into force September of this year) states that:. 8220;The applicant should make every effort to address these areas [failure to comply with best practice criteria]. Before the eCTD is submitted to the agency. The use of links withi...

3

Apex Regulatory's Blog: June 2011

http://apexregulatory.blogspot.com/2011_06_01_archive.html

Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Thursday, June 30, 2011. So, what do I mean by ‘effective document management’? Well, from my experience working in a number of systems and seeing first hand the nightmares that substandard document management can cause, I would simmer it down to the following question:. This document, could. Successor or theirs…. How are you naming.

4

Apex Regulatory's Blog: Fixing a broken MD5 checksum

http://apexregulatory.blogspot.com/2011/11/fixing-broken-md5-checksum.html

Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Thursday, November 24, 2011. Fixing a broken MD5 checksum. Some eCTD publishing software comes with a tool which allows for the creation of xml files and valid MD5 checksums for eCTDs which have been published and then edited in the eCTD output folder. ISI’s. Are two publishing tools which incorporate this handy feature. Example: After Q...

5

Apex Regulatory's Blog: July 2012

http://apexregulatory.blogspot.com/2012_07_01_archive.html

Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Thursday, July 12, 2012. ECTD: Literature in the Article 8(3) Mixed Application (EU). This short post concerns the submission of Literature References in "Full Mixed" applications under Article 8(3). I don't think it is discussed in any eCTD specific guidance (or if it is, I couldn't find it! For publishing purposes, temptation (and logi...

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Apex REGISTRY for the apex in domain name registrations!

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apexregistry.com apexregistry.com

Apex REGISTRY for the apex in domain name registrations!

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apexregulatory.blogspot.com apexregulatory.blogspot.com

Apex Regulatory's Blog

Welcome to our blog! Apex will use this blog to post updates, hints and tips about all things relevant in the field of Regulatory Operations. We hope you find it useful. Saturday, June 29, 2013. EU eCTD Specification 2.0 - Are You Prepared? Implementation of the Module 1 EU Specification update from Version 1.4.1 to Version 2.0 becomes mandatory. How Will the Updates Affect Me? I was recently in contact with someone who was unsure whether the changes to Module 1 would affect their company at all. The bot...

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Physical Therapy Houston, Sugar Land, Katy | Apex Physical Therapy

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apexrehab.org.sg apexrehab.org.sg

Index

Coming soon, look out for these! Welcome to our Apex Day Rehabilitation Centre for the Elderly website. Our Centre is located at Blk 119 Bukit Merah View in Central Singapore. We provide day care and rehabilitation services for the frail and disabled elderly in the community. Feel free to navigate to the various sections of this website, and contact us if you need other information. Enjoy your visit here. This website is developed with co-funding support from the VWOs-Charities Capability Fund (VCF).

apexrehabcare.com apexrehabcare.com

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