Juanita J Price Regulatory Publishing LLC was created to explore how to support your regulatory, quality, and compliance objectives.  The company is a US based organization within the Pharmaceutical industry with Global Regulatory Affairs (GRA) experience at various pharmaceutical companies including GlaxoSmithKline, Triangle Regulatory Publishing, MMS Holdings Inc. and Intercept Pharmaceuticals (Alfasigma).

The JJP RegPub team members have experience in managerial positions (Manger/Sr Manager, Principal Submission Specialist) with expertise in many areas and specifically the following:

• Archival

  • CRO zipfile upload of submissions and correspondence into FileZilla

  • FDA Correspondence email and hardcopy

  • Veeva RIM classification

  • Veeva RIM creation of binders/folders

     

• Authoring and Prepublishing support

  • Starting Point templates

  • Formatting and prepublishing support

  • Sharepoint

     

• eCTD Publishing Support

  • ESG Next Gen

  • eCTD Modules 1 through Module 5

  • DocuBridge

  • Veeva Vault RIM

  • eCTD v3.2 (v4.0 pending year 2029)

Managed and maintained authoring/publishing support submitted by Regulatory Affairs staff in the US, to include: Discovery Regulatory, Biopharm (US and UK), NCR, CMC (Pre Approval [NA and UK], Post Approval [NA, UK and RoW]) NCR and Therapeutic Groups

How can we help you:

• Convert CTD dossiers into fully compliant eCTD format

• Manage complete submission lifecycle with accuracy

• Ensure alignment with ICH and regional regulatory standards

Our Key Services Include:

• Document Formatting: eCTD-ready structure with precision

• Final Approved File Publishing: Creation of bookmarks and links/hyperlinks

• Technical Validation: Error-free, submission-ready dossiers

• Submission Management: Timely and compliant filings

• Lifecycle Management: Modules 1 through 5

• Regulatory Consultation: Expert guidance tailored to your market

Whether you're transitioning from paper-based submissions or maintaining ongoing eCTD lifecycles, we ensure a smooth, compliant, and efficient process.

Why Partner with Us?

• Customized solutions for CRO and companies

• Experienced regulatory operations professionals

• Over 30 years of training staff in RegOps and the various Therapeutic field.

• Quick turnaround support

Our moto is "Medical Writers and Reg Affairs/Strategy, focus on the content or data being distributed to the vendor or being submitted to the FDA and allow JJP Regulatory Publishing to fill in the gap once the document is ready for formatting and prepublishing by Regulatory Operations as we focus on providing the agency with eCTD accuracy."