Regulatory Affairs

RegSource Consulting is a company dedicated to regulatory affairs consulting for the pharmaceutical, biotechnology, Generic and Medical Device industries.  RegSource Consulting provides regulatory solutions for companies of all sizes and at all stages of development. 

Our senior consultants have many years of experience working with worldwide regulatory agencies and have thorough knowledge of the processes involved and current guidance documents.  We also have very strong experience in creating new or developing current regulatory affairs departments.

Planning and implementing an IND/NDA/BLA/MAA etc. is a significant undertaking for any organization.  Having been through the process many times before, the RegSource Consulting team can help your organization manage the processes to achieve successful product submissions and approvals.

We can also help to arrange training for your organization on all the requirements of a CTD and eCTD and ensure that your application meets the most current global filing requirements. 

We have experience in filing many different types of applications including:

      • Investigational New Drug (INDs) Applications
      • New Drug Applications (NDAs)
      • Abbreviated New Drug Applications (ANDAs)
      • Biologic License Applications (BLAs)

Other areas of expertise include:

  • Compliance training tailored to your company's specific requirements in the areas of:
    • GLP, GCP, GMP
    • Regulatory Compliance

And Technical Writing services for:

  • Quality Manuals
  • Standard Operating Procedures

 

Regulatory Operations

We provide strategic and operational consulting regarding Regulatory Operations.

We can provide long term Regulatory Operations planning and short term planning to ensure successful submissions to all worldwide regulatory agencies.  Our consulting support includes:

Submissions Management

  • Submission Project Management for all type of submissions
  • Clinical/Non-Clinical/CMC/Regulatory submission planning
  • Detailed Project Planning
  • Detailed Submission Metrics
  • Guidance/Standards Interpretation (how and when to apply)

Common Technical Document and electronic Common Technical Document Submission Planning:

  • Publishing plans for all type of submission types
  • MAA/NDA/BLA to CTD section mapping
  • IND to eCTD format
  • 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 systems that meets the clients needs to fulfill all Regulatory Affairs/Clinical/Non-clinical and CMC compliance 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
Email: Info@regsourceconsulting.com