FDA Regulatory Solutions/LCM

IT’S NOT ENOUGH TO FOCUS ON THE PRESENT…SUCCESS REQUIRES THAT YOU PLAN AHEAD.

BY IDENTIFYING & INTEGRATING WHAT IS, WHAT IS REQUIRED, WHAT IS POSSIBLE & WHAT WOULD ADVANCE YOUR PORTFOLIO, 
IngeNEWity CAN HELP YOU PREPARE THE RECIPE FOR AN ENTICING NEAR & LONG TERM BUSINESS STRATEGY WITH KEY
INGREDIENTS YOU WON’T FIND ELSEWHERE.

A RECIPE THAT INCORPORATES:

• A HEALTHY PORTION OF REGULATORY CREATIVITY & INNOVATION
• A GENEROUS SERVING OF LIFE CYCLE MANAGEMENT (LCM) ADVICE THAT CAN HELP SUSTAIN, FORTIFY & KEEP YOU COMPETITIVE & STRONG FOR YEARS TO COME.

IngNEWity Has Distinctive Experience respecting Pharmaceutical, Device and Diagnostic Products and Issues.  Let IngeNEWity Manage These Issues for You
Generally,  Working with Your Providers, Recommend Providers and/or Explore Detailed Services that a separate entity, Pharmidable Legal Advisors, 
LLC can provide. (For more about the relationship between the principals of IngeNEWity and Pharmidable, see link to the Legal Notices, Disclaimers
and Terms of Use and Privacy below.  For more information about Pharmidable’s services, please visit www.pharmidablelegal.com).   

IngeNEWity Can Help You Outline a Working Strategy to Develop or Exploit FDA REGULATORY Benefits such as :

• Product  Features that Support Bioequivalence (BE) &/or Confer Safety/Efficacy Benefits to Enhance Protections,
• Increase Product Life/Pipeline/Investor Interest, through:
  • Litigation  Avoidance
  • PI, Labeling & IFU Strategies
  • Unique Indication/Exclusivity/Dosage/Therapeutic/Design/Delivery Ideas
  • Considering  Generic Threats,  Strengths & Weaknesses
  • Product Differentiation Strategies

LCM:

• Perform a Gap Analysis between Where Your Company Is/Where It Could/Should Be, including by:
  • Outlining the Framework for, Implementing, Recommending or Partnering with Providers to Deliver an LCM Plan
    and Establish an LCM Team to:
    • Maximize  Protection  of Key Product  Patents/Features
    • Identify New Indications/Therapies/New or Additional Dosage Forms & Exclusivities
    • Suggest Alternative Products for Line Extensions/Enhanced Pipelines
    • Recommend New IP/Regulatory Submissions/Arguments to Extend Exclusivity
    • Develop Novel Arguments to Extend Product Lifecycle
    • Use of Citizen Petitions to Facilitate Patient Benefits & Protect Assets
• Explore the Generic Challenge & Litigation Potential  Presented  by Your Product & Its Features, by:
  • Identifying/Assessing/Evaluating/Strategizing re:
    • Potential for & Hurdles to Generic Design Around of Your Product Patents
    • 505(b )(2) Opportunities & Threats/Competitive Landscape
    • IP/Regulatory Issues & Proposed Fixes
    • Avoidance of Potential for Illicit Generic Entry

CALL OR EMAIL⁺ TODAY TO SEE HOW IngeNEWity CAN HELP! INITIAL CONSULTATION FREE!

PHONE: 1-484-883-4522
EMAIL: rjzakreski@ingeNEWitylegal.com
____________________________________________________________________________________________
⁺ Please note that for purposes of this contact you should not include any confidential or sensitive information in your transmission to IngeNEWity Legal
    Consultants, LLC as no attorney client-relationship is established unless and until a formal engagement agreement has been signed. Please see “Website
    Disclaimers” section of the link to Legal Notices, Disclaimers and Terms of Use and Privacy below.