Regulatory Information Management

The Life Sciences regulatory and business environment is complex and constantly evolving. Our holistic RIM platform offers a streamlined approach that enables Life Sciences companies to achieve long term business benefits beyond compliance.

A streamlined approach across all stages of product development life cycle

Amplexor Regulatory Information Management (RIM) solutions enable life sciences companies to drive, manage and control the processes of releasing new products or maintaining existing products on the market:

 

  • Managing information throughout the products lifecycle
  • Planning and tracking regulatory activities
  • Managing interactions with health authorities and other regulatory bodies
  • Overseeing the authoring, reviewing and approving of submission documents
  • Supporting global label management processes
  • Planning, compiling, reviewing, publishing, submitting and managing submissions
  • Managing product data and content in line with the IDMP target operating model (TOM)

Our RIM Products

Regulatory Content Management

R&DExpert™

Regulatory Planning & Tracking

RIMExpert™

Product Information Management

ProductExpert™

Submission Management and Publishing

SubmissionExpert™

Labeling Management

LabelExpert™

Regulatory Analytics

Benefits

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