Regulatory Checklist

Let OSR help you complete all the necessary steps for each phase of the drug development cycle! We can help you navigate each phase to accelerate time to market, save costs, and improve your drug’s chances of achieving regulatory success. 

PHASE 1:

  • Develop a Strategy Document and Investor Presentation:
    • Country filing plan
    • Filing Strategy
    • Designations sought
    • Chemical, preclinical, clinical planning
    • Risks to approval
    • FDA dialogue strategies
  • Leverage technology and commercial analysis to assess opportunities and build:
    • Target Product Profile
    • Company Core Data Sheets (CCDS)
    • EU Summary of Product Characteristics (SPC)

PHASE 2:

  • Collaborate with cross-functional team to design Phase III trial to deliver target product claims
  • Design labeling policy and process
  • Develop label to support product commercialization and differentiation
    • Prioritize key sections and language
    • Determine how indications and trial design will be stated
    • Develop local labels for target markets worldwide
  • Develop regulatory action steps and timelines to ensure progress through each phase

PHASE 3/NDA Submission:

  • Manage complex labeling and regulatory situations and negotiations
    • Anticipate FDA commentary and develop plan to respond to FDA comments
    • Prepare alternative wording with rationale based on prior precedent
  • Develop US Package Insert, Medication Guide, and Patient Information Leaflets
  • Negotiate the approval process with FDA and health authorities

LAUNCH:

  • Preparation of supplements and amendments
  • Submission of promotional items

CMC Checklist

Let OSR help you complete all the necessary steps for each phase of the drug development cycle! We can help you navigate each phase to accelerate time to market, save costs, and improve your drug’s chances of achieving regulatory success. 

PHASE 1:

  • Develop drug manufacturing strategy

PHASE 2:

  • Develop plan for Agency Meetings & Submissions
    • Identify strategies for agency meeting requests and timing
    • Prepare for meetings with agencies. Anticipate and manage feedback
    • Prepare brief packages and dossiers that maximize CMC and quality information

PHASE 3/NDA Submission:

  • Define processes to complete module 3 of the CMC section
  • Transition from clinical to commercial manufacturing
    • Identify potential manufacturing and testing facilities for drug substance and product
    • Validate the commercial manufacturing process and identify regulatory and stability requirements
    • Identify requirements for US vs ex-US manufacturing
    • Determine testing for global markets and requirements for analytical method validation

Monitoring & Compliance Checklist

Let OSR help you complete all the necessary steps for each phase of the drug development cycle! We can help you navigate each phase to accelerate time to market, save costs, and improve your drug’s chances of achieving regulatory success. 

PHASE 2:

  • Develop a Monitoring and Compliance Plan in accordance with the “Seven Elements of an Effective Compliance Plan”, outlined by the Office of Inspector General (OIG).
    • Determine who will provide compliance expertise and guidance
    • Determine level of training and resources needed for internal team
    • Determine what policies and compliance systems are needed
    • Communicate internally and publicly, company’s commitment to compliance

PHASE 3/NDA Submission:

  • Develop process to report spending activities to the Government for the Physician Payment Sunshine Act
  • Develop a compliance monitoring plan
  • Plan for focused area monitoring (e.g. field representative ride-alongs, live speaker programs, medical affairs activities)
  • Leverage digital monitoring technology

LAUNCH:

  • Ongoing monitoring and compliance improvement
  • Monitoring in response to CIA

 Advertising and Promotional Review Checklist

Let OSR help you complete all the necessary steps for each phase of the drug development cycle! We can help you navigate each phase to accelerate time to market, save costs, and improve your drug’s chances of achieving regulatory success. 

PHASE 3/NDA Submission:

  • Identify review committee members (medical, legal, regulatory)
  • Develop promotional review SOP’s
  • Identify review and approval platform
  • Review, provide feedback and ensure all promotional materials and programs are compliant prior to production and release (press releases, speaker training, sales tools, payer presentations)
  • Prepare OPDP submission for pre-clearance

LAUNCH:

  • Review all promotional materials and programs prior to production and release
  • Incorporate OPDP feedback and assist with promotional campaign revisions

Commercial Analysis & Operations Checklist

Let OSR help you complete all the necessary steps for each phase of the drug development cycle! We can help you navigate each phase to accelerate time to market, save costs, and improve your drug’s chances of achieving regulatory success. 

PHASE 1:

  • Market Assessment
  • Competitive Intelligence
  • Market Research – identify market gaps: HCPs, patients, and payers
  • Forecast Modeling

PHASE 2:

  • Situation Analysis
  • Quantitative and Qualitative Market Research
  • Sales and manufacturing forecast
  • Pricing and Reimbursement landscape

PHASE 3/NDA Submission:

  • Targeting and Segmentation
  • Competitive differentiation
  • Campaign/logo/message development and testing
  • Infrastructure planning (marketing and sales operations

LAUNCH:

  • ATU tracking studies
  • Message recall
  • Gap analysis

Commercial Planning Checklist

Let OSR help you complete all the necessary steps for each phase of the drug development cycle! We can help you navigate each phase to accelerate time to market, save costs, and improve your drug’s chances of achieving regulatory success. 

PHASE 1:

  • TPP development – indication prioritization
  • Generic naming

PHASE 2:

  • Positioning, strategy, strategic objectives
  • TPC development
  • Commercial Roadmap
  • Integration with Medical Affairs
  • Publication strategy
  • Trade packaging
  • Brand naming
  • Packaging input
  • Lifecycle planning

PHASE 3/NDA Submission:

  • Strategic and tactical launch planning
  • Pricing and market access plan
  • Trade and Distribution
  • KOL engagement plan
  • Advertising, medical education media, and PR agency selection
  • Sales force planning
  • Launch meeting preparation

LAUNCH:

  • Launch Plan execution
  • Sales and national account manager training
  • Launch meeting
  • Performance Analysis