We help companies navigate the complex challenges of drug product development and manufacturing.

 Rely on ResoPharm to help drive your new API product development.

ResoPharm Consulting LLC enables companies to navigate the complex regulatory, technical, and operational challenges of API drug product development and manufacturing by providing direct access to seasoned, industry-proven leaders.

  We provide comprehensive support across:

  • Chemistry, Manufacturing, and Controls (CMC)

  • Process and supply chain development

  • External supplier and CDMO project management

  • Development of New Chemical Entities (NCEs)

Luckner G. Ulysse, Ph.D., MBA

Founder, ResoPharm

Dr. Luckner G. Ulysse is an accomplished pharmaceutical executive with more than 28 years of experience spanning global pharmaceutical companies and leading CDMOs/CMOs. He brings deep expertise across early discovery, process development, late-stage development, and commercialization of innovative medicines.

Over the course of his career, Dr. Ulysse spent 13 years at Merck & Co. and 15 years in senior leadership roles at Bachem and AMRI. He has led CMC development efforts for multiple Merck marketed products, including Bridion®, Noxafil® IV, Isentress® HD, and led the early scaleup of the first authorized COVID-19 drug, Lagevrio. He contributed to process improvements for Nesina® (Alogliptin).

Beginning as an NIH pre-doctoral fellow and a bench scientist, he advanced to executive leadership positions such as Vice President & General Manager at Bachem Americas and Vice President of Chemical Development at AMRI.

Dr. Ulysse holds a Ph.D. in Bio-Organic Chemistry from Purdue University and an MBA from American University (Washington, DC).

 Our Services

 Technical & CMC

  • Chemical process R&D for small-molecule and peptide APIs

  • Support on process development, optimization, and scale-up

  • Non-GMP and GMP manufacturing support with preferred CDMO partners

  • Guidance on analytical method development and physicochemical characterization

  • CMC strategy development and coordination

  • RFP preparation, supplier evaluation, and ongoing supplier management

  • Authoring and review of technical development reports and regulatory CMC documentation (IND/NDA)

  • Drug substance optimization through salt selection and polymorph screening

  • Peptide synthesis optimization, including upstream/downstream processing, resin selection, protecting-group strategies, and impurity control

Operations Management

  • Operations management and implementation of Lean operations

  • Operational excellence initiatives, including shop-floor management, Lean Six Sigma deployment, and tiered production systems

  • Structured problem-solving, root-cause investigations, and resolution

  • Supply chain strategy design and capacity planning models

  • Development and implementation of risk-management frameworks

  • Strategic CAPEX planning and business-case development, including financial modeling and sensitivity analysis

Strategy & Change Management Execution

  • Long-term manufacturing and supply chain strategy development

  • Product-specific and market-driven operational strategies

  • Supply chain diversification and process portability initiatives

  • Effective change-management execution to ensure strategic impact

  • Execution-focused workshops and leadership alignment

Areas of Expertise

  • Small-Molecule APIs   

  • Peptides                 

  • Supply Chain Resiliency

  • Analytical Sciences

  • Risk Management

  • CMC   

  • Salt Selection & Polymorph Screening

  • Process Development

  • Validation

  • Non-GMP/GMP Mfg   

  • PAT

  • Commercialization

Ready to drive your development program forward?

Reach out to schedule a complimentary consultation and explore how we can accelerate your next milestone.