FDA and other Regulatory advice Solutions

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