Be accountable for establishing, maintaining, adjusting and communicating Regulatory Submission deadlines to ensure that all product launch related functional area activities can be planned accordingly.

More Uses of the Regulatory Submission Toolkit:


• Support document preparation for test and Regulatory Submission of new/existing designs.
  
  

• Warrant that your strategy prepares safety reports for Sponsor approval, Regulatory Submission and investigator notification.
  
  

• Control: Regulatory Submission audits.
  
  

• Determine requirements (local, national, international) and options for Regulatory Submission, approval pathways, and compliance activities.
  
  

• Communicate and interacts with regulatory authorities before and during the development and review of a Regulatory Submission through appropriate communication tools.
  
  

• Generate, coordinate and manage Regulatory Submission documents for new products or changes to existing health authorities filings.
  
  

• Be accountable for experiencing in design history file preparation for Regulatory Submission.
  
  

• Lead: Regulatory Submission authorship (technical sections).
  
  

• Generate, coordinate and handle Regulatory Submission documents for new products or changes to existing health authorities filings.
  
  


Save time, empower your teams and effectively upgrade your processes with access to this practical Regulatory Submission Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any Regulatory Submission related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated Regulatory Submission specific requirements:

STEP 1: Get your bearings

Start with...


• The latest quick edition of the Regulatory Submission Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.


Organized in a Data Driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…


• Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation


Then find your goals...

STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 999 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which Regulatory Submission improvements can be made.

Examples; 10 of the 999 standard requirements:


1. How do you verify if Regulatory Submission is built right?
   
   

2. Do you have the authority to produce the output?
   
   

3. How risky is your organization?
   
   

4. Who gets your output?
   
   

5. What information is critical to your organization that your executives are ignoring?
   
   

6. What is the scope of the Regulatory Submission effort?
   
   

7. What are the top 3 things at the forefront of your Regulatory Submission agendas for the next 3 years?
   
   

8. How do you plan for the cost of succession?
   
   

9. What were the criteria for evaluating a Regulatory Submission pilot?
   
   

10. Who have you, as a company, historically been when you've been at your best?
    
    


Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:


• The workbook is the latest in-depth complete edition of the Regulatory Submission book in PDF containing 994 requirements, which criteria correspond to the criteria in...


Your Regulatory Submission self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:


• The Self-Assessment Excel Dashboard; with the Regulatory Submission Self-Assessment and Scorecard you will develop a clear picture of which Regulatory Submission areas need attention, which requirements you should focus on and who will be responsible for them:
  
  


• Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix

• Gives you a professional Dashboard to guide and perform a thorough Regulatory Submission Self-Assessment

• Is secure: Ensures offline Data Protection of your Self-Assessment results

• Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:



STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage Regulatory Submission projects with the 62 implementation resources:


• 62 step-by-step Regulatory Submission Project Management Form Templates covering over 1500 Regulatory Submission project requirements and success criteria:


Examples; 10 of the check box criteria:


1. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?
   
   

2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?
   
   

3. Project Scope Statement: Will all Regulatory Submission project issues be unconditionally tracked through the Issue Resolution process?
   
   

4. Closing Process Group: Did the Regulatory Submission project team have enough people to execute the Regulatory Submission project plan?
   
   

5. Source Selection Criteria: What are the guidelines regarding award without considerations?
   
   

6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed Regulatory Submission project plan (variances)?
   
   

7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?
   
   

8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?
   
   

9. Procurement Audit: Was a formal review of tenders received undertaken?
   
   

10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?


 
Step-by-step and complete Regulatory Submission Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:


• 1.1 Regulatory Submission project Charter

• 1.2 Stakeholder Register

• 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:


• 2.1 Regulatory Submission Project Management Plan

• 2.2 Scope Management Plan

• 2.3 Requirements Management Plan

• 2.4 Requirements Documentation

• 2.5 Requirements Traceability Matrix

• 2.6 Regulatory Submission project Scope Statement

• 2.7 Assumption and Constraint Log

• 2.8 Work Breakdown Structure

• 2.9 WBS Dictionary

• 2.10 Schedule Management Plan

• 2.11 Activity List

• 2.12 Activity Attributes

• 2.13 Milestone List

• 2.14 Network Diagram

• 2.15 Activity Resource Requirements

• 2.16 Resource Breakdown Structure

• 2.17 Activity Duration Estimates

• 2.18 Duration Estimating Worksheet

• 2.19 Regulatory Submission project Schedule

• 2.20 Cost Management Plan

• 2.21 Activity Cost Estimates

• 2.22 Cost Estimating Worksheet

• 2.23 Cost Baseline

• 2.24 Quality Management Plan

• 2.25 Quality Metrics

• 2.26 Process Improvement Plan

• 2.27 Responsibility Assignment Matrix

• 2.28 Roles and Responsibilities

• 2.29 Human Resource Management Plan

• 2.30 Communications Management Plan

• 2.31 Risk Management Plan

• 2.32 Risk Register

• 2.33 Probability and Impact Assessment

• 2.34 Probability and Impact Matrix

• 2.35 Risk Data Sheet

• 2.36 Procurement Management Plan

• 2.37 Source Selection Criteria

• 2.38 Stakeholder Management Plan

• 2.39 Change Management Plan


3.0 Executing Process Group:


• 3.1 Team Member Status Report

• 3.2 Change Request

• 3.3 Change Log

• 3.4 Decision Log

• 3.5 Quality Audit

• 3.6 Team Directory

• 3.7 Team Operating Agreement

• 3.8 Team Performance Assessment

• 3.9 Team Member Performance Assessment

• 3.10 Issue Log


4.0 Monitoring and Controlling Process Group:


• 4.1 Regulatory Submission project Performance Report

• 4.2 Variance Analysis

• 4.3 Earned Value Status

• 4.4 Risk Audit

• 4.5 Contractor Status Report

• 4.6 Formal Acceptance


5.0 Closing Process Group:


• 5.1 Procurement Audit

• 5.2 Contract Close-Out

• 5.3 Regulatory Submission project or Phase Close-Out

• 5.4 Lessons Learned


Results

With this Three Step process you will have all the tools you need for any Regulatory Submission project with this in-depth Regulatory Submission Toolkit.

In using the Toolkit you will be better able to:


• Diagnose Regulatory Submission projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices

• Implement evidence-based best practice strategies aligned with overall goals

• Integrate recent advances in Regulatory Submission and put Process Design strategies into practice according to best practice guidelines


Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.

Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Regulatory Submission investments work better.

This Regulatory Submission All-Inclusive Toolkit enables You to be that person.

Includes lifetime updates

Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.