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  • Conceptualization

  • Research and Analysis

  • Hypothesis Development

  • Experimental Design

  • Data Collection and Analysis

  • Iterative Process

  • Regulatory Considerations

  • Prototyping and Development

  • Testing and Validation


  • Market Research and Segmentation

  • Competitive analysis

  • Scope evaluation

  • Digital Globalization Strategy

  • Content Creation

  • Translation / Localization tools 

  • Engagement and Interaction

  • KPI Analytics

  • Adjust and Iterate

  • Scaling and Commercialization

  • Track analysis and Adaptability


Guidance is Only for Following documents mentioned under each Application Category:

  • Investigational New Drug (IND) Application - Drug Information, Preclinical Data

  • Clinical Trial Authorization (CTA) - Chemistry, Manufacturing, and Controls (CMC) Information, Preclinical Data

  • New Drug Application (NDA) or Marketing Authorization Application (MAA) - CMC Information, Safety Data, Risk-Benefit Analysis, Labeling Information, Post-Marketing Surveillance Plan

  • Drug Master File (DMF) - Manufacturing Processes, Quality Control, Stability Data

  • Common Technical Document (CTD) - Quality data (Module 3), Nonclinical data (Module 4)

  • Request for proposal (RFP) - Only for Life Sciences Research Devices


  • Identify Common Goals and Objectives

  • Thoroughly Research Potential Partners

  • Build Strategic Relationships

  • Define Clear Objectives

  • Develop Win-Win Value Proposition

  • Assist in Reviewing Quality Assurance / Manufacturing Clauses in Agreements Assist in Revie

  • Design Tools to Secure Funding

  • Establish Communication Channels

  • Project Management

  • Monitor Progress and Gain Trend

  • Disseminate Results 

  • Evaluate Closure


Numerous life sciences companies offer products and services that align with consumer preferences, yet a substantial disparity exists between actual growth and desired levels due to a gap between industrial strategies and consumer preferences.

Growing the business means building on the strengths to improve the company's capacity for innovation - both in what the company offers and how it offers. 


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