Regulatory Open Forum

I am currently working with a small pharmaceutical firm who recently committed to FDA to file their NDA in an eCTD format. The company has limited in-house regulatory support and limited hands-on experience with eCTD submissions. Can anyone recommend a vendor they have successfully partnered with to submit an electronic eCTD to FDA?  Would be ideal if this vendor has successfully worked with drug/device combination products submissions. 

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Lori DonDiego RAC, MBA
Principal Consultant, Regulatory Affairs
Livermore CA
United States
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I recommend Accenture/Octagon based on my experience.
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John Parker PhD
VP, RA & Quality Systems
Lansdale PA
United States
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Original Message:
Sent: 01-09-2015 19:58
From: Lori DonDiego
Subject: Seeking Recommendations for eCTD Submission Publishing Vendors

I am currently working with a small pharmaceutical firm who recently committed to FDA to file their NDA in an eCTD format. The company has limited in-house regulatory support and limited hands-on experience with eCTD submissions. Can anyone recommend a vendor they have successfully partnered with to submit an electronic eCTD to FDA?  Would be ideal if this vendor has successfully worked with drug/device combination products submissions. 

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Lori DonDiego RAC, MBA
Principal Consultant, Regulatory Affairs
Livermore CA
United States
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Hi there,

Having worked with multiple vendors, I would also recommend Accenture. In your comparison you may find that they are pricey, but the regulatory support they offer is excellent.

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Kimberly Lager MS
RRD International, LLC
Rockville MD
United States
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Original Message:
Sent: 01-09-2015 19:58
From: Lori DonDiego
Subject: Seeking Recommendations for eCTD Submission Publishing Vendors

I am currently working with a small pharmaceutical firm who recently committed to FDA to file their NDA in an eCTD format. The company has limited in-house regulatory support and limited hands-on experience with eCTD submissions. Can anyone recommend a vendor they have successfully partnered with to submit an electronic eCTD to FDA?  Would be ideal if this vendor has successfully worked with drug/device combination products submissions. 

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Lori DonDiego RAC, MBA
Principal Consultant, Regulatory Affairs
Livermore CA
United States
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Dear Lori, The Biologics Consulting Group is a full-service vendor for US regulatory filings, including NDAs. We can help your client with the writing and perform the formatting, publication and even electronic filing of the documents. Especially for a small company, BCG can be a cost-effective solution, since your client would not have to hire a publishing staff or purchase their own publishing software (which can be quite pricey as noted). We have experts on staff in Devices, as well as Biologics and Drugs, so would be able to cover all aspects of your client's combination product. Please feel free to contact me if you would like further information about our services. ------------------------------------------- Debra Barngrover RAC Senior Consultant Biologics Consulting Group Southborough MA United States -------------------------------------------
Original Message: Sent: 01-09-2015 19:58 From: Lori DonDiego Subject: Seeking Recommendations for eCTD Submission Publishing Vendors I am currently working with a small pharmaceutical firm who recently committed to FDA to file their NDA in an eCTD format. The company has limited in-house regulatory support and limited hands-on experience with eCTD submissions. Can anyone recommend a vendor they have successfully partnered with to submit an electronic eCTD to FDA? Would be ideal if this vendor has successfully worked with drug/device combination products submissions. ------------------------------------------- Lori DonDiego RAC, MBA Principal Consultant, Regulatory Affairs Livermore CA United States -------------------------------------------

Dear Lori,

I work for PAREXEL Consulting where we provide regulatory consulting and submission services.  I think we could provide you with the regulatory support you are looking for.  We have extensive regulatory knowledge (including combo products) led by senior ex-FDA officials from various disciplines within the agency (e.g. devices, blood, oncology, biologics, etc.).  We also have a dedicated filing team that files several successful eCTD NDAs a year for our clients.

If you would like find out more, I'm happy to answer any questions.  My email address is Julia.Jiang@parexel.com.

Kind regards,
Julia

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Julia Jiang RAC
Manager & Senior Consultant, Regulatory Affairs
PAREXEL Consulting
Bethesda, MD
United States
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Original Message:
Sent: 01-09-2015 19:58
From: Lori DonDiego
Subject: Seeking Recommendations for eCTD Submission Publishing Vendors

I am currently working with a small pharmaceutical firm who recently committed to FDA to file their NDA in an eCTD format. The company has limited in-house regulatory support and limited hands-on experience with eCTD submissions. Can anyone recommend a vendor they have successfully partnered with to submit an electronic eCTD to FDA?  Would be ideal if this vendor has successfully worked with drug/device combination products submissions. 

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Lori DonDiego RAC, MBA
Principal Consultant, Regulatory Affairs
Livermore CA
United States
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Hi Lori,

I will be happy to help your client in eCTD Submission and Publishing. My company, Global Regulatory Partners-LLC  is specialized in small pharma and biotech companies. We provide them with all types of regulatory services including eCTD submission and publishing to FDA at very competitive cost. 

Please check out our website : www.globalregulatorypartners.com and let me know if you need more details.

Best regards.

Suzan Davis.



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Suzan Davis
Framingham MA
United States
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Original Message:
Sent: 01-09-2015 19:58
From: Lori DonDiego
Subject: Seeking Recommendations for eCTD Submission Publishing Vendors

I am currently working with a small pharmaceutical firm who recently committed to FDA to file their NDA in an eCTD format. The company has limited in-house regulatory support and limited hands-on experience with eCTD submissions. Can anyone recommend a vendor they have successfully partnered with to submit an electronic eCTD to FDA?  Would be ideal if this vendor has successfully worked with drug/device combination products submissions. 

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Lori DonDiego RAC, MBA
Principal Consultant, Regulatory Affairs
Livermore CA
United States
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Hi Lori,

We will add our note to those offering up support.  TekTeam is a SF Bay Area small consulting firm comprised of professionals with expertise in eCTD, NDAs, PMAs, BLAs and combination product filings.  We would be happy to help you and your client in this effort.  Feel free to contact me via RAPS, our website at www.tekteam.net or phone at 1.650.320.1720 if you would like to discuss.  If we cannot serve your needs, we are happy to point you to others who would be a good fit.

Best regards,
Denise

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Denise Gottfried RAC
President/CEO
TekTeam, LLC
Palo Alto CA
United States
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Original Message:
Sent: 01-09-2015 19:58
From: Lori DonDiego
Subject: Seeking Recommendations for eCTD Submission Publishing Vendors

I am currently working with a small pharmaceutical firm who recently committed to FDA to file their NDA in an eCTD format. The company has limited in-house regulatory support and limited hands-on experience with eCTD submissions. Can anyone recommend a vendor they have successfully partnered with to submit an electronic eCTD to FDA?  Would be ideal if this vendor has successfully worked with drug/device combination products submissions. 

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Lori DonDiego RAC, MBA
Principal Consultant, Regulatory Affairs
Livermore CA
United States
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Hi Lori,

I work with Donna Kato and her regulatory submissions consulting group located in Northern California. Her group is a pleasure to work with, knowledgeable, timely, small with reasonable fees. They manage all my submissions in eCTD format.  Her contact information is donna@regprofessional.com.  
Good luck,

Dar

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Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
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Original Message:
Sent: 01-09-2015 19:58
From: Lori DonDiego
Subject: Seeking Recommendations for eCTD Submission Publishing Vendors

I am currently working with a small pharmaceutical firm who recently committed to FDA to file their NDA in an eCTD format. The company has limited in-house regulatory support and limited hands-on experience with eCTD submissions. Can anyone recommend a vendor they have successfully partnered with to submit an electronic eCTD to FDA?  Would be ideal if this vendor has successfully worked with drug/device combination products submissions. 

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Lori DonDiego RAC, MBA
Principal Consultant, Regulatory Affairs
Livermore CA
United States
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