Global Regulatory Sciences and Drug Development
Bridge both sides of the Pacific on the path to an approval.
Pacific Horizon Biopharma Consulting bridges global regulatory landscapes — partnering with biotech and pharmaceutical innovators to design strategies that anticipate regulatory trends, de-risk development, and bring therapies to patients faster.
Who We Are
Strategic regulatory judgment, at each stage of the lifecycle.
Founded by regulatory and drug development experts with decades at the center of global drug development, Pacific Horizon Biopharma Consulting brings senior-level strategy to programs that span East and West — from discovery through approval and beyond.
We work as an extension of your team — translating complex, shifting agency expectations into clear, defensible strategy, and standing beside you in the rooms where it matters most.
Every engagement is led by a principal. No hand-offs, no learning curve — just experienced hands on your program from day one.
Heidi Wang, Ph.D.
Brings more than 30 years of global pharmaceutical leadership across multinational pharmaceutical and clinical-stage biotechnology companies. Expertise spanning Regulatory Strategy, drug development, executive leadership, and corporate governance. Lived and worked in Asia for over six years, serving as CEO, Board Member, and Chair while leading global Regulatory and R&D organizations and advancing development programs from early development through commercialization.
Michelle Meng, Ph.D., RAC
Brings complementary expertise in regulatory strategy and execution across the product lifecycle. Nearly 20 years of global regulatory leadership across multinational pharmaceutical and clinical-stage biotechnology companies. Expertise spanning Regulatory Strategy, Regulatory CMC, and Regulatory Operations, leading global programs from early development through worldwide registrations and lifecycle management.
What We Do
Regulatory strategy, submissions, and agency interactions — end to end.
A focused set of services covering the moments that determine whether a program moves forward.
Regulatory Strategy & Roadmaps
End-to-end development strategy, target product profile, and lifecycle planning aligned to your commercial goals.
Agency Interactions & FDA Meetings
Pre-IND, Type A/B/C and end-of-phase meetings — briefing books, question strategy, and rehearsal.
Clinical-Stage Submissions
Enabling and maintaining your studies across regions, from first-in-human through pivotal trials.
Marketing Applications
Submission planning, authoring oversight, and filing readiness for NDA, BLA, and MAA dossiers.
Global Regulatory Bridging
Harmonized strategy across US FDA, EMA, PMDA, NMPA, and emerging markets — connecting global regulatory pathways into one comprehensive plan.
Designations & Due Diligence
Fast Track, Breakthrough, RTOR (real time Oncology review), Project Orbis, and orphan designations, plus regulatory gap assessments for diligence.
Our Approach
Why teams bring us in.
Anticipate the agency trend
We plan to where the reviewer will be, not just where the guidance is today — surfacing the hard questions early, while there is still time for mitigation.
Principal-led, always
The experience you hire is the experience that does the work. Your program is led by a founding principal from first call to final submission.
Strategy you can defend
Clear rationale, documented decisions, and a path that holds up under scrutiny — from your board to the review division.
Get in touch
Let's map the path to your next milestone.
Whether you're preparing for a first agency meeting or planning a marketing application, we'd welcome a conversation about where your program is headed.