Regulatory Solutions*

LIKE IN SPORTS, A BALANCED ATTACK WINS GAMES, A LONG VIEW WINS CHAMPIONSHIPS AND MULTIPLE CHAMPIONSHIPS ARE A DYNASTY!

LET US HELP YOU CREATE A ROBUST, OUTSIDE THE BOX REGULATORY PLAYBOOK TO SUPPLEMENT AN INTELLIGENT PATENT STRATEGY AND FACILITATE LONG TERM COMMERCIAL SUCCESS.

 

We can: 

  • Consider technology features that support Bioequivalence, confer safety/efficacy benefits and create a forward looking Citizen's Petition Strategy
  • Consider Package Insert, Labeling & Instructions for Use Strategies to enhance protections
    • Assess/Enhance your product's "Effective Exclusivity" - leverage safety/other product features rendering it unique (“Complex”) and potentially difficult to copy well past expiry of traditional exclusivities
  • Consider potential platform, combination product, bi-modal therapies, diagnostic, OTC and dosage form strategies to enhance product lifeline/pipeline and interest in your portfolio
  • Evaluate availability of Regulatory Exclusivities (NCI/NCE/PTE/PMA/Pediatric/Orphan) and strategies such as GAIN Act to extend product life and/or facilitate new indications/therapies
  • Consider alternative delivery technologies to enhance safety/efficacy/market reach and overall investor interest
  • Consider if any generic products can walk the Bioequivalence/Infringement/Doctrine of Equivalents Tightrope
  • Consider, manage and/or help you take Regulatory advantage of your Safety/Product Liability Profile
  • Identify achievable baseline clinical studies to differentiate your product/expand potential indications
  • Consider and help address the Generic Challenge Potential presented by your product:
    • Identify those features of your product that present hurdles or render it more susceptible to potential Design Around
    • Identify IP/Regulatory issues and propose fixes
    • Assess potential for Generic Entry
  • Evaluate 505(b)(2) opportunities (RLD issues) and threats
  • Evaluate landscape of competitive branded/generic products
  • Work With Your, Identify and/or Manage Outside Regulatory Counsel

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

PHONE: 1-484-883-4522 or 1-484-667-6959
EMAIL: rjzakreski@pharmidablelegal.com or rthrubiec@pharmidablelegal.com

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