starling access

mapping possibilities, accelerating science
never reach a decision point unprepared

As tens of thousands of starlings gather and transform in striking unison throughout their voyage, we bring your rapidly moving R&D parts and stakeholder interactions together into flow to create a harmonized, strategic, and living whole.

Regulatory affairs consultants. Drug development consultants.

We are a Global Regulatory Science and Strategy consultancy specializing in accelerated R&D and optimized access by mapping the future possibilities for your novel therapies, using an integrated stakeholder lens.

STARLING ACCESS PROVIDES THE UNIQUE SET OF INTEGRATED EXPERTISE AND STRATEGIC VISION NEEDED TO EFFECTIVELY ACCELERATE YOUR MEDICINES TO PATIENTS

Strategic Advice

Strategic advice, diligence, and solutions to overcome regulatory and R&D challenges.

Design Strategy Maps

Design, build, and tailor integrated strategy maps to evolve with your programs and company.

Strategic Storyboarding

Strategic storyboarding, leadership, writing, and expert review services for every type of regulatory document and dossier across the entire lifecycle of your medicinal products.

HOW STARLING ACCESS CAN HELP TO OPTIMIZE YOUR REGULATORY AFFAIRS AND DRUG DEVELOPMENT

  • Drug Development Consulting

    Accelerated R&D Strategy

    Regulatory Interaction / Scientific Advice Strategy

    Regulatory Risk Assessment and Mitigation Approaches

    Due Diligence

    Managed Access Programs

    • MAP Policy and Website Content

    • Early Access strategy – Compassionate Use, Emergency Use, Right to Try, Named Patient, ATU

    Scientific, Regulatory, Payer, and Patient Advisory Board Preparation

    Interpretation of guidance and legislation from the regulator and payer viewpoints

    Identify lean and strategic resource needs with operational evolution to harness the potential of every individual

  • Stakeholder Interaction Mapping – integrating the global patient, physician, regulator, payer, investor lenses, and IP considerations across the product lifecycle

    Generate and Evolve Integrated Strategic Global R&D to Access Plans (ISP) – decision mapping, R&D strategy, stakeholder feedback- and data-driven inflection points and timeline/strategy optionality

    Biomarker, Trial Enrichment, COA Tool, Endpoint and Labeling Strategy

    Expedited Regulatory Pathways

    Target Product Profile

    Registry and RWE Strategy

    Registration and Regulatory Roadmap

    Launch Sequencing

    Phase-appropriate and Company-tailored SOP Strategy

  • Health Authority Briefing Packages for Scientific and Regulatory Advice

    • Pre-IND

    • Clinical-Nonclinical and Quality Scientific Advice-Protocol Assistance

    • EMA/HTA Parallel Scientific Advice

    • All FDA Meeting Types

    • FDA Written Advice Requests-Information Amendments

    • Risk identification and mitigation approaches

    • Global Brand Name submissions

    Fast Track Designation

    BTD-R and Breakthrough Therapy Designation

    Orphan Drug Designation

    PIPs

    SME Designation

    CTD dossiers – new submissions, amendments, variations and supplements

    • IND, NDA/BLA, MAA

    Promotional Material Review

    Labeling, Target Product Label, and CCDS

We bring a highly strategic and creative lens to supercharge traditional program and portfolio management and dossier planning approaches, harnessing cutting-edge regulatory science honed through decades of rare disease and precision medicine development where patients’ lives are on the line every day. 

We ensure that your nonclinical, clinical, CMC, IP, IR, regulatory, patient advocacy, medical affairs, and commercial planning elements flow and evolve together. You never reach a milestone or decision point unprepared.

Alix Alderman,
FTOPRA Founder

starling access contact