FDA and other Regulatory advice Solutions

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  • 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 and/or serve as your Fractional (Part-Time) legal department

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