Strategic consulting for new ventures including R&D planning, market positioning, investor pitch development, and early-stage operations setup.
Bridging the gap from academic discovery to commercial product. Services include IP assessment, proof-of-concept validation, and licensing strategy.
Support for transferring lab-scale processes to GMP environments. Includes documentation development, process adaptation, tech transfer packages, and cross-site coordination.
Partnering, licensing, and commercialization support for international market access. Includes distributor onboarding, deal structuring, and strategic expansion planning.
End-to-end support from formulation and in vivo studies to IND-enabling studies, GMP manufacturing, and commercial readiness.
Full-spectrum CMC development and gap analysis. Authoring and reviewing CTD modules, QbD implementation, and regulatory alignment for nanomedicines.
Custom-built platforms and facility designs for cutting-edge modalities, including microfluidics, single-use systems, and continuous manufacturing.
Design and optimization of robust, scalable processes for nanoparticle formulations. Includes process mapping, parameter identification, and equipment fit analysis.
Operational strategy execution for biotech & pharma groups expanding into international markets: cross-border supply chain development, regulatory alignment, manufacturing partnerships, site selection, and operational scaling.
Ensuring the right analytical tools are in place is critical to product success. I assist in developing, validating, and transferring analytical methods that meet ICH guidelines and support product quality, safety, and efficacy throughout development.
Custom design and optimization of delivery vehicles such as liposomes, LNPs, polymeric nanoparticles, and hybrid systems for targeted, controlled delivery.
Pre-formulation studies, excipient screening, compatibility studies, and optimization of stability, bioavailability, and therapeutic performance.
Design, execution, and documentation of studies required for IND filings and FDA preclinical review meetings.
Design and implementation of quality systems aligned with GMP. Preparation for audits, IND submissions, and compliance with FDA, EMA, and ICH guidelines.
Planning, layout design, and operational readiness for pharmaceutical cleanrooms and manufacturing facilities including ISO classifications and process flows
Development of Master Batch Records (MBRs), Batch Production Records (BPRs), SOPs, and quality documentation workflows.
Design and oversight of clinical manufacturing plans including packaging, labeling, and release for Phase I–III trials.
Design and implementation of quality systems aligned with GMP. Preparation for audits, IND submissions, and compliance with FDA, EMA, and ICH guidelines.
ICH-compliant stability studies for nanoparticle drug products including accelerated, long-term, and stress testing protocols.
Comprehensive risk assessments for product development, scale-up, and regulatory pathways with proactive mitigation plans.
Support in qualifying raw material vendors, CMOs, testing labs, and logistics providers to ensure reliability and compliance.
Preparation and execution of technical due diligence packages for funding rounds, licensing deals, or acquisitions.
Authoring and reviewing regulatory submissions including IND, IMPD, NDA, and post-approval variations.
Support for formulation updates, new indications, product line extensions, and post-market surveillance strategies.