⌬01
Development & CMC Strategy
Align QTPP, CQA, comparability, and stage-appropriate development plans with your development phase and target markets.
- Development roadmap
- QbD
- Regulatory strategy
Biopharmaceutical R&D · CMC Advisory
From lab to approval,decisions grounded in evidence.
I trace the links between decisions across R&D, process development, GMP, and regulatory strategy. Independent advice grounded in both operational and regulatory realities makes your next decision clearer.
End-to-EndFrom R&D to regulatory strategy
Biologics portfolioAntibodies · Biosimilars · Vaccines · Recombinant proteins · Exosomes
Hands-onProcess development · Tech transfer · GMP experience
IndependentIndependent judgment, free from vendor ties
Consulting Services
Practical advice tailored to your project bottleneck
I structure evidence and options so your team can make better decisions—not simply hand over a one-size-fits-all answer.
◫02
Process Development & Scale-up
Identify critical variables and risks across upstream and downstream processes, and review scale-up and CDMO technology-transfer strategies.
- Lab scale
- Pilot scale
- Manufacturing scale · Tech transfer
◇03
GMP & Quality Systems
Assess readiness and execution systems for clinical trial material (CTM) manufacturing, facility operations, deviation management and CAPA, and data integrity.
- Transition to GMP
- CAPA
- Process validation
◎04
Biologics Portfolio
Address modality-specific development and CMC issues for antibodies, biosimilars, vaccines, recombinant proteins, and exosomes.
- Antibodies
- Biosimilars
- Vaccines
- Recombinant proteins
- Exosomes
First Conversation
Three questions for the first meeting
I begin with the decision you need now, not a lengthy proposal. The first conversation defines project priorities and the scope of engagement.
01 / DECISIONWhat decision must be made now?
02 / EVIDENCEIs there enough evidence to support it?
03 / RISKWhat could cause the next milestone to fail?
How I Work
From defining the problem to deciding the action
Start with a focused review or work together through a critical decision point.
STEP 01
Assess the Context
Clarify the project stage, objectives, available data, and most urgent decision.
STEP 02
Structure the Issues
Connect scientific, process, quality, and regulatory risks and priorities into one coherent rationale.
STEP 03
Evaluate Options
Compare options by feasibility, cost, timeline, and regulatory impact.
STEP 04
Support Execution
Turn decisions into concrete next actions through meetings, document reviews, and decision records.
Field-built Expertise
Bridging laboratory data with GMP operations
R&D
End-to-end Biologics Development
Development strategies for antibodies, biosimilars, vaccines, recombinant proteins, and exosomes.
CMC & MANUFACTURING
Connecting Process and Analytics
Connect the development lifecycle from cell line and culture through purification, analytics, scale-up, CDMO tech transfer, and process validation.
QUALITY & REGULATORY
Development Decisions with Approval in Mind
Assess data completeness and control strategy through the lens of ICH guidelines and FDA, EMA, and MFDS expectations.
Bio RealTalk
Biopharma development insights that work in practice
Bio RealTalk turns guideline language into practical decisions. Lectures and whiteboard explainers address the essential issues in biopharmaceutical development.
BIO REALTALK · FIELD NOTE
Why must a robust process also be explainable?
The rationale connecting CQAs, CPPs, and the control strategy
R&D / CMC / GMP
FAQ
Frequently Asked Questions
Which project stages can you advise on?
Advisory support spans early research direction, process development, CTM manufacturing readiness, technology transfer, and CMC review for regulatory submissions. The scope is tailored to your current stage and critical decisions.
How are engagements structured?
Options include a one-time expert review, recurring advisory meetings, document and data review, or milestone-based support. Scope and deliverables are agreed before kickoff.
How is confidential information handled?
An NDA can be executed first, and only the minimum information required for the engagement is handled. Security and return-of-material terms are specified in the agreement.
Do you perform experiments or submit applications?
No. The engagement does not include conducting experiments or analyses, preparing research deliverables on your behalf, or submitting to regulators. I review plans and results produced by your team, CDMO, or CRO and organize the decision rationale and options.
Start a Conversation
Contact by Email
Let’s start with your most urgent decision.
Send your company name, project stage, and the decision you are finding most difficult. I will review where advisory support can help.