Whatever your Regulatory need, CUSTOpharm has a custom solution for you.
Electronic Submissions (eCTDs)
CUSTOpharm specializes in electronic submissions and has been doing so for 7 years. Over 80+ eCTD filings have been done and 375+ FDA Electronic Gateway (ESG) Submission Filings CUSTOpharm has worked with various divisions at the FDA to submit ANDAs, NDAs, INDs, and DMFs.
Electronic Hybrids
Not all FDA divisions or clients are required and/or ready to submit in eCTD. CUSTOpharm works with clients to develop a plan that allows the most efficient and effective compilation, authoring, review and submitting of applications, amendments and supplements.
Paper Applications/CTD/Traditional Format
As many firms and the FDA transition to eCTD, various hybrids evolve such as paper CTDs, paper CTD/traditional hybrids, and various derivations including those with electronic components. CUSTOpharm is well versed in these various formats and works with clients to establish a plan and provide guidance to compile, author, review and submit applications.
What types of Regulatory Support do we provide?
CUSTOpharm provides compilation, authoring, publishing and submission services for various application types. Our submission services include associated submissions in addition to the original applications (amendments, supplements, annual reports). We work with our clients to determine the level of need and provide support that the client requires including necessary templates for authoring of electronic documents and regular update reports once the compilation, authoring and editing process begins.
¨ Abbreviated New Drug Applications (ANDAs)
¨ New Drug Applications (NDAs)
¨ Investigational New Drug Applications (INDs)
¨ Drug Master Files (DMFs)
Other Regulatory Activities
In addition to major filings, we also provide support for other regulatory functions including:
Structured Product Labeling
Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging medication information. SPL labeling is required for new drug product submissions. CUSTOpharm can prepare new SPL labeling and amend existing SPL labeling. Please see the FDA’s SPL Resource Page for additional information.
Establishment Registration
CUSTOpharm offers Establishment Registration assistance to firms required to register with the FDA according to 21 CFR 207 using FDA Form 2656. CUSTOpharm provides reminders to register and assists firms in registering with the FDA according to the guidelines set forth. CUSTOpharm also offers associated US Agent Services for foreign clients. Please see our US Agent Services website for additional information. To find out how to register with the FDA and learn who is required to register, visit the FDA instructions page for FDA Form 2656.
Drug Listing
Drug Listing, similar to Establishment registration is required of all approved drug products being distributed in the US. Drug Listing is required upon approval, change in status and every six (6) months in June and December unless otherwise directed by the Agency. CUSTOpharm offers Drug Listing assistance to firms required to list drugs with the FDA. CUSTOpharm also offers associated US Agent Services for foreign clients. Please see our US Agent Services website for additional information. To find out how to list drugs with the FDA and learn who is required to list drugs, visit the FDA instructions page for FDA Form 2657.
Open DMF Compilation and Authoring
CUSTOpharm offers compilation and authoring services for clients looking to establish technical packages for API, and open DMF parts for clients. Many manufacturing facilities need to be able to provide certain information to clients using their product or services for inclusion in applications to be sent to the FDA. CUSTOpharm offers compilation and authoring services to establish the information required for a submission and prepare the documentation for use with the organization’s various clients.
RA Procedural Development, Guidance, Instruction and Training
As many firms and the FDA transition to eCTD, development of procedures, best practices, guidance, instruction and training are a necessity. CUSTOpharm offers training for clients in various areas of Regulatory Submission preparation and guidance throughout the utilization of our services including templates.
Our Regulatory Support Service is also able to be packaged with other services and products we offer like Project Management, Product Development, Tech Transfer and Pub-Assist. For a more inclusive package, The CUSTOpharm Program incorporates the Regulatory Support with Product Development.
Contact us if you would like additional information regarding any of the Regulatory Support services we offer.
Also, check out our Links/Recent & Upcoming News and Events page for important regulatory links and recent news and events.