We help you make progress in drug development and commercialization without growing infrastructure  

We provide expertise in all aspects of CMC and CMC Regulatory,  DMPK, Toxicology and Pharmacology,  Regulatory Strategy and Submissions, QA and Auditing,  Launch Readiness and Supply Chain for both small molecule and Biologics programs as well as for combination products.

 

SCOPE OF RECENT SUPPORT

PRODUCTS &  MARKETS

Global and In-country expertise has supported clients to date in North America, Europe and Asia

  • All therapeutic areas
  • NMEs, Repurpose & Rescue
  • Combination Therapies
  • Human and Animal Health

TECHNOLOGIES

A wide range of experience has enabled support of a wide range of technical requirements

  • Small Molecules
  • Peptides & Proteins
  • Vaccine, Cell & Gene Therapy
  • Natural Products
  • All dosage forms & routes 

REGULATORY 

Broad regulatory experience has supported strategy and execution

  • IND, NDA, BLA, MAA & 505b2
  • All CDER Divisions
  • Orphan Designation
  • Fast Track, & Breakthrough
  • Combination products

DEVELOPMENT ACCELERATION

PLANNING

  • IND & NDA Readiness
  • Development Plans
  • Scenario Planning
  • Actionable Task-Level Gantts
  • Cost & FTE Estimates

EXECUTION

  • Can Lead and Do
  • Can Advise and Coach
  • Oversee CROs & CDMOs
  • ID Key Hiring Needs & Timing
  • Write & Publish Submissions

COST-EFFECTIVE OUTSOURCING SUCCESS 

EFFICIENT VENDOR SELECTION

  • Rapid Vendor ID & Selection
  • Our Knowledge =  Right Fit
  • MSA & Contract Negotiation 
  • Both Selection & Oversight

GLOBAL VENDOR OVERSIGHT

  • On-Site Expertise
  • Local QA & QPs
  • Save on Costly Travel & Time
  • Serve as Head of QA
  • Technical & Regulatory

RAPID DILIGENCE

THE RIGHT EXPERTS

    • Network of Targeted Experts
    • Broad and Deep Experience
    • One Call to Make
    • Can Start in Hours, not Days
    • Custom Fit to Your Unknowns
    • Focused Answers

    ACTIONABLE OUTPUT

    • Coordinate Team for You
    • Data Room Triage
    • Fatal Flaws> Issues> Deep Dive
    • Consolidated Output
    • Cost, Time to Address Gaps
    • Technical &Regulatory

    WE WORK CLOSELY WITH YOU TO TAILOR SUPPORT TO COMPLEMENT YOUR TEAM

    MOVE FORWARD, MANAGE INFRASTRUCTURE

    We provide expertise in all aspects of CMC, CMC regulatory, QA and Auditing, DMPK, Toxicology and Pharmacology, Regulatory Strategy and Submissions, Launch Readiness, Supply Chain, Due Diligence and other areas.  We do this for both large and small molecule programs as well as for combination products.

    RIGHT AMOUNT, RIGHT EXPERTISE, RIGHT TIME

    Our leaders work closely with you to tailor support to complement your current team.  Our proven broad and deep network, combined with our approach, enables rapid access availability  to support your timelines, all the time.

    ADVICE AND HANDS-ON EXECUTION

    Clients ask us to review their submissions or help write them.  Clients rely on us to serve as their Quality Unit as well as to perform audits, leveraging our in-country auditors around the world.  We are counted on to do, advise, review and / or coach. Our expert resources can be as hands-on or as advisory as you need.  Our support can be as variable as you need but is always engaged and committed to your success.

    EASY ACCESS TO EXPERT RESOURCES

    A simple and cost-effective business model that provides targeted expertise and broad development experience to help you move forward while managing risk, cost and time.

    Support is as variable to you as you need

    but is always engaged and committed.

    Our team members don't just have experience, they have been accountable for results in their areas of expertise