Navitas Life Sciences

E-Submissions to FDA

Electronic IND Submission Services

The FDA (both CDER and CBER) provided the industry with recommendations on developing INDs and other applications in the harmonized electronic technical document (eCTD) format.

In the revised guidance (April 2006 eCTD guidance), the FDA notes its clear interest in promoting electronic submissions, including eINDs, in the eCTD format as early as possible in the development process.

Navitas believes it is most beneficial to begin your eCTD-based submissions with the initial submission of an application in the format recommended by the agency. The maximum benefit will be derived once an application is in electronic format. This is particularly true starting with an IND, and submitting sequences to the IND electronically over the full development cycle.

Navitas’ pharmaREADY IND submissions consulting team:

Has extensive experience supporting many of our small and medium-sized life science companies to build a well-designed eIND in CTD format that provides the framework for and permitting the “rolling” generation of an NDA during drug product development. This increases the potential of providing life science companies with a tremendous time–savings advantage by giving it a head start on the marketing application.
Can support customers in helping them to do IND updates and amendments in eCTD format mid-stream, even if their initial submission was done in paper and in non CTD format.
Can provide detailed IND review consulting and help customers face pre-IND meetings with the FDA.

The Navitas pharmaREADY IND Regulatory operations consulting team has expertise in:

Developing submissions project plans and roadmaps
Ensuring Agency-specific document formatting and Publishing
Creating CTD structuring and document content plan
Submission compilation and Life Cycle Management
Support and Management of Pilot submissions
Performing as Liaison between FDA and the sponsor company
eSubmissions Gateway Setup

The Navitas pharmaREADY team can augment the sponsor company’s Regulatory Operations team with pharmaREADY Regulatory Operations personnel. This staff augmentation is particularly useful if the customer is facing submissions deadlines and needs assistance in adding qualified regulatory operations people to their publishing team.

For small size biotechnology companies, we provide Pay per Use On-Demand technology solutions to create eCTD-based IND submissions. For further information, please check our On-Demand Services page.

Electronic ANDA Submission Services

The office of Generic Drugs has seen a significant increase in the number of ANDA submissions in eCTD format in the last 3 years. The number of eCTD submissions increased from 76 applications and 318 submissions in October 2006 to 1296 applications and 4857 submissions in October 2008.

FDA’s goal to implement a standards-based end-to-end fully electronic receipt, review and dissemination environment based on eCTD would make the ANDA review process simpler and faster. The Generics companies doing ANDA submissions with FDA are strongly encouraged to do eCTD submissions.

Navitas pharmaREADY is the most popular publishing brand within the generics industry. pharmaREADY consulting and technology divisions combined have successfully completed hundreds of ANDA submissions in eCTD format for Generics companies.

The pharmaREADY ANDA submissions consulting team is well suited to provide valuable guidance in improving all elements of a reviewable eCTD ANDA.

pharmaREADY offers the following regulatory operations services to ensure FDA-acceptable eCTD-enabled ANDA submissions.

Submission Map creation in CTD format
Granularity and lifecycle management of documents
FDA-specific document formatting and publishing
Navigation Aid Management including the table of contents and hyperlinks
Dossier assembly and compilation in eCTD format
Paper-to-Electronic document conversion to provide searchable text-based documents as required by FDA
Electronic Submissions gateway setup and administration
Liaison with FDA and act as an agent between the sponsor and FDA

For small size Generic companies, we provide Pay per Use On-Demand technology solutions to create eCTD-based ANDA submissions. For further information, please check our On-Demand Services page.

Electronic Drug Master File (DMF) Submissions

According to FDA’s recent guidance, API (Active Pharmaceutical Ingredient) or bulk drug manufacturers are encouraged to submit their DMFs (Drug Master Files) in electronic form, including updating current paper DMFs. All applications to CDER, including DMFs that are submitted in electronic format MUST be in eCTD format, unless a waiver has been granted. http://www.fda.gov/cder/regulatory/ersr/waiver.htm

The Navitas pharmaREADY eSubmissions consulting team can provide cost-effective solution enabling the API manufacturers to submit DMFs in eCTD format. pharmaREADY has helped many API companies to do eCTD-based DMF submissions.

pharmaREADY offers the following regulatory operations services to ensure FDA-acceptable eCTD-based DMF submissions.

Module 1 Document mapping and granularity management
DMF lifecycle management including the Amendments and Annual report
DMFs that cover multiple items, e.g., container closure systems (Type III) or Flavors
(Type IV) in eCTD
Electronic Signatures in DMFs
FDA-specific document formatting and publishing
Navigation Aid Management including the table of contents and hyperlinks
Dossier assembly and compilation in eCTD format
Paper-to-Electronic document conversion to provide searchable text-based documents as required by FDA

For small size API companies, we provide Pay per Use On-Demand technology solutions to create eCTD-based DMF submissions. For further information, please check our On-Demand Services page.