Submissions

US Submission Services

At any stage of drug, biologic or medical device development we can provide the following regulatory affairs services.

Pre-Phase 1/Phase 1

• Pre-IND Meeting (and all meetings)
  • Create the meeting minutes
  • Attend the meeting
  • Conduct rehearsals
  • Plan the meeting
  • Meeting package
  • List of issues
  • Agenda
  • Create the "request for meeting letter"

• IND

  • Write sections
  • Manage timeslines/project management
  • Review sections
  • Compile all needed documents
  • Publish it for submission to the Agency

• End of Phase I Meeting

Phase 2/3

• IND Maintenance – write and file any updates to the IND
• Pre-NDA Meeting
• End of Phase II/Pre-Phase III Meeting
  
  

New Drug Application/Biologics Licensing Application
All work will be provided in a Common Technical Document (CTD) format

• Administrative section (Module 1)
• Nonclinical section (Module 2.4, 2.6)
• Clinical Section (Module 2.5, 2.7)
• Chemistry, Manufacturing and Control (Module 2.3, 3)
• Package Insert
• Clinical Study Reports
• Integrated Summary of Safety
• Integrated Summary of Effectiveness

All Stages

• Annual Reports – write and file any updates to the IND
• Safety Reporting – write and file any updates to the IND
• Investigator Information – compile and submit new investigator information to Agency
• Regulatory strategy – help plan the filing, drug development process and provide advice on what information to submit at what time point
• Regulatory Information – we can provide information on the competitors (publicly available information) product, regulatory intelligence that could impact their developmental program and general regulatory questions
• Regulatory Tracking Database – a database that tracks all regulatory Agency interactions and submissions
• Review of marketing materials & press releases for regulatory compliance

Device Clients

• IDE (Investigational Device Exemption) – write, submit and file any updates to the IDE
• 510(k) – write and submit premarket notification submission
• PMA (Premarket Approval Application) – write, submit and file any updates
• Regulatory Strategy
• Regulatory Information

Global Submissions

What can we do for you on a global scale? We have experience conducting regulatory submission in over 32+ countries and know the good, bad and pitfalls associated with it. Let our expertise help you in:

• Global clinical trial regulatory planning and strategy
• Documentation and translation planning
• Writing, managing, submitting and maintaining regulatory documentation
• Scientific Advice Meetings: request, meeting information package planning and creation, and meet and negotiate with regulators in key countries

Medical Writing

We love to write and pull together a comprehensive story about your compound in the simplest terms possible because the simpler the story, the better it is read and understood. What can we effectively write (and have written a lot of)?

• Clinical protocols
• Investigator s’ Brochures
• Clinical Study Reports
• INDs and NDAs
• Medical journal articles
• Publication planning
• Standard Operating Procedures (SOPs) for both Clinical and Regulatory

Publishing

We can write, prepare, compile, and publish both paper and electronic submission documentation needed to initiate and support a US based IND, ex-US global clinical trial application or a marketing application filing. We offer the following publishing services:

• Variety of compliant templates for regulatory submissions
• Formatting, bookmarking and hyperlinking
• Paper publishing in the traditional IND or CTD format
• Conversion of traditional IND format to the CTD format
• Publishing eCTD ready and compliant files; all in a PDF format with hyperlinks (for easy management if converting to an electronic system or for working with electronic publishing vendors).

While paper publishing is done in-house, for fully electronic submissions we work with a variety of experienced electronic publishing vendors.

Editing
We can review/edit documentation for Health Authority compliance, acceptability, readability, grammar and message comprehension.

Formatting
We can format documentation to match your style guide or our own and to make sure your documentation is compliant with electronic publishing standards.

Binding
If a document is submitted in paper, which most small companies are doing for economical reasons, you will need to bind any submission over 20 pages and they need to be compliant to the Health Agency and ICH standards. We offer the following binding services for paper submissions:

• Pagination and dividing the submission into the appropriate number of volumes
• Printing and collating
• Preparation of tabs
• Binder label creation
• Binding volumes and shipping to Health Agencies