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2. Five Steps for Complying with New eCTD requirement for DMF Submissions
   
   08th Feb 2016 I Sumit Gupta
   
   U.S Drug Master files are filled by various companies involved in the business of Bulk Drug, Excipients, Primary packaging Material and other products/services dealing with pharmaceutical products. US DMF is divided into 5 categories
3. Type1 - Plant Master file - NO longer Used
4. Type 2 - API - Bulk Drug
5. Type 3 - Primary Packaging Material
6. Type 4  - Excipients
7. Type 5 - FDA Accepted Reference Information.
9. U.S FDA will no longer accept paper submission after 5th May 2017 for DMF submission, all DMFs, amendments, annual updates will have to be filled electronically as specified by the FDA in eCTD guidance. 
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    Source - US FDA Website : www.fda.gov
    
    Its official anyone planning to do a DMF submission to USFDA after 5th May 2017 will have to add eCTD to their plans, all companies who have their annual budget fixed at the start of the year consider adding eCTD to their budget from now itself as implementing any new system or software requires time.
                                                                                     
                                                               “Start Early Finish Early”
    
    The big question or matter of confusion for most people is what happens of old Submission which are made in paper format ??,Good news is you don’t have to resubmit entire DMF in eCTD format, but all your further subsequent amendments, LOA, or annual reports will be required in eCTD only.
    
    Now that you know eCTD will soon be compulsory, let’s look at the some steps that will help you comply with this new requirement.
    
    1) Buying an eCTD Software
12. There are many vendors available in the market with eCTD software and each one of them have so many features it becomes really difficult to choose one. So you need to remember the basic objective while selecting one
    1.          a) Easy to USE
               b) Can Make Validated and good submission to the Agency you are targeting
               c) It should be 21CFR Part 11 compliant
               d) Should be Cost Efficient
               e) Link Validation and PDF Validation should be an integral feature of the software
    3. Some eCTD Software do come with Document management systems which are very handy when it comes to large amount of data to be processed or there are many users in a company working on same products.Many companies are today adopting eBMR, and going digital with all their records right from production, QC, QA, Regulatory to final dispatch and further track and trace.
    4.                       "Digitalization of documentation is a BIG Plus for Smooth eCTD transition"
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    6. Confused to buy or to Outsource read our below article???
       Buying eCTD software vs Outsourcing eCTD Submission
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1. 2) Trained & skilled Manpower
   With Specialized software new regulation training becomes an integral part of the whole transition process. Training is the KEY for implementing the new system and making successful submission. Companies can train their existing RA team in eCTD by hiring external Professionals who have good experience in the field or they can approach training institute to provide the same
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1.                          ** GIRA provides Practical training in eCTD - Click eCTD Training for Details
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1. 3) Now that you have the tools (software) trained manpower for eCTD you should look forward to validating your system by making a dummy submission to US FDA and getting the technicalities of eCTD Approved from them.
3. 4) The First Step in eCTD Dummy Submission is opening an ESG Gateway Account with US FDA to transmit your eCTD Submission.
13. 5) Next you Create a Sample eCTD submission validate the same and submit it to U.S FDA for reviewing.
1. Please note US FDA won’t review technical information and sample submissions are not considered official submissions
   
   The Support team will check your submission for various test including, DTD Validation, Verification of file checksums, verification of the presence of modified files and identification of missing files.
   
   Once the entire test is complete a report will all the errors will be sent to you. Once all the errors are corrected you can re-submit the corrected sample submission to the team for further review.
   
   After Successful completion of above steps the submission should be technically ready for official submission.
   
   Wola you have Successfully Completed your first eCTD Submission and now you are in time to comply with the new regulation come 5th May 2017.
   
2. About the Company Perfect Pharmaceutical Consultants Pvt Ltd
4. PPC has more than 30 years of Regulatory experience in Pharmaceutical field  we can help you :
5. a) Convert existing Paper Submission to eCTD
6. b) File Annual reprort/ Amendment in eCTD format with US FDA , Health Canada , EU nations, and other eCTD Accepting countries.
7. c) We write , compile and submit Drug Master file for US FDA and other countries

Contact US for any Query or an Obligation Free Quote - Enquire for eCTD Now 

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