Consultant Feedback

"The Consultants particular strength has been in identifying and implementing state-of-the-art practices to keep up with and anticipate changes in the regulatory environment."
Senior Director, Top 10 Biotechnology Company
Regulatory Operations
RegSource Consulting can provide Regulatory Operations planning to ensure successful submissions to all worldwide regulatory agencies. Our consulting support includes:

Submissions Management

  • Submission Project Management for national and international Agencies
  • Clinical/Nonclinical/CMC functional group regulatory submission planning
  • Detailed Submission Metrics
  • Regulatory Guidance/Standards Interpretation for regulatory submissions (how and when to apply)
  • Electronic and Paper submission planning
     
Common Technical Document and electronic Common Technical Document Submission Planning:

  • Regulatory Publishing and planning for all major regulatory submissions
  • Publishing plans for all type of submission types
  • MAA/NDA/BLA to CTD section mapping
  • IND to eCTD format conversion planning
  • Assisting organizations create/publish and ship CTD and eCTD type applications to worldwide agencies
  • General consulting on electronic publishing in the global regulatory environment


Selecting Regulatory and enterprise systems that meets the client's needs to fulfill all Regulatory Affairs/Clinical/Nonclinical and CMC compliance and submission requirements from:

  • Collecting user requirements
  • Process Mapping (As is/To be)
  • Writing URS/FRS documents
  • System selection
  • Business validation support
  • System implementation
  • Writing training manuals/SOP's
  • Education Workshops
  • Creating & implementing communication plans
  • Project and Program Management
  • Enterprise implementation support


Template Design and creation

Retention Policies

Legacy Data Migration Planning

Implementation of Document Management Systems

Structured Product Labeling Submissions