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Providing the right solution based on your needs

Process Definition & Optimization

Documented and optimized processes are critical for ensuring consistency of information prepared and submitted to regulatory authorities is as intended. Powell Regulatory Service can help companies ensure the work their people are performing is adding value to the organization , reduce rework, streamline operations, while producing the best quality work product by performing a current state process review and optimizing the process through elimination of non-value add steps, and having clear roles and accountability.

Standards Definition & Data Governance

Regulatory agencies are constantly adopting or changing the ways in which they want to receive information, with the latest trend supporting adoption of improved electronic submissions.  Powell Regulatory Services can help companies ensure their ability to effectively and efficiently reuse content and produce compliant regulatory submissions by harmonizing standards and implementing regulatory data governance processes.

Requirements Definition & Vendor Selection Assistance

Powell Regulatory Services can assist companies with defining user requirements and managing the request for information or request for proposal process for software intended to assist with preparation, publishing, and managing regulatory information including:

  • Document Management

  • Submission Publishing (eCTD, NeeS, paper, etc.)

  • Submission Planning and Tracking

  • Registration Management

  • Submission Viewing

Education & Training

Powell Regulatory Services can provide education and training to organizations on regulatory operations or regulatory affairs topics.  Educational sessions can be tailored to your organization based on the experience and needs of the participants.  Training can occur remotely in a webinar format or at your designated location.  

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Some examples of the types of training performed include:

  • eCTD Education

  • Submission Authoring Skills

  • Electronic Submission Standards 

  • Regulatory Data Governance

  • Effective Submission Management Teams

Benchmarking

Powell Regulatory Services conducts benchmarking studies specifically related to regulatory operations.  In addition, we partner with Gens & Associates, an industry recognized benchmarking practice, for studies related to Regulatory Information Management

eCTD Templates & Authoring Style Guide

Powell Regulatory Services can provide eCTD compliant authoring templates and associated Style Guide.  Templates can be purchased "as-is" or customized to your company preferences.

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