Our Capabilities

Specialized CMC Solutions for Complex Modalities

From first-principles formulation to commercial-scale manufacturing defense, we leverage Quality by Design (QbD) to provide the technical rigor required to move breakthrough assets through the clinic

Modality 01

Complex Solid Oral Dosage Forms

Leveraging deep expertise in formulation and process development (BCS Class II/IV compounds), we design robust solid dose strategies that emphasize bioavailability and stability. Our approach integrates Real-Time Release Testing (RTRT) and predictive modeling to ensure commercial readiness.

  • ✦ Immediate & Modified Release Dosage Forms
  • ✦ Amorphous Solid Dispersions (ASD) & Lipid-Based Systems
  • ✦ Statistical Formulation & Process Optimization
  • ✦ Scale-Up Physics and Mechanistic Blending Models
Dissolution vs API Particle Size Optimization
Lyophilization Primary Drying Cycle Visual
Modality 02

Complex Sterile Injectables

Sterile development requires a relentless focus on stability, aseptic processing, and container-closure integrity. We specialize in de-risking high-value liquid and lyophilized assets.

  • ✦ Formulation of Sensitive Small Molecules and Proteins / Peptides
  • ✦ Vials, Prefilled Syringes and Auto-Injectors
  • ✦ Extractables & Leachables, Elemental Impurities, and Nitrosamines
  • ✦ Terminal Sterilization of Thermally Sensitive Drugs
Modality 03

Operational Excellence in R&D & Manufacturing Sciences

Maximizing organizational agility by synchronizing resource utilization and lean workflows with integrated digital applications to accelerate the transition from molecule to market.

  • ✦ Resource Utilization & Optimization
  • ✦ Workflow Optimization
  • ✦ Digital Strategy Development & Execution
Resource Allocation Dashboard

Complex exits don’t have to be chaotic

While a checklist provides the roadmap, the execution requires a steady hand to mitigate risk and protect your assets. Let’s discuss how I can manage the heavy lifting of your restructuring.

DOWNLOAD THE SITE DECOMMISSIONING CHECKLIST Schedule a Strategic Consultation →

EHS • HR • Asset Recovery • GxP

Modality 04

Strategic Restructuring & Facility Decommissioning

"Mitigating organizational risk by orchestrating compliant facility exits and workforce transitions through rigorous EHS protocols and change management."

We provide end-to-end oversight to ensure your reputation and bottom line remain protected during periods of significant organizational change.

  • ✦ Human Capital: Designing retention strategies, severance frameworks, and outplacement frameworks that honor your team and retain critical knowledge.
  • ✦ Asset Recovery: Managing equipment lifecycles—from decontamination certification to high-value redeployment or resale.
  • ✦ EHS Compliance: 100% compliance with hazardous waste disposal, radiation safety, and GxP documentation archival.
  • ✦ Site Closeout: Coordinating utility "safe-offs" and neutralizing lab environments to meet strict lease-end obligations.

Technical Reference Information

Dissolution as a Function of Particle Size

  • Noyes, A. A., & Whitney, W. R. (1897). The rate of solution of solid substances in their own solutions. JACS. [Link]
  • Hixson, A. W., & Crowell, J. H. (1931). Dependence of reaction velocity upon surface and agitation. I&EC. [Link]
  • Aulton, M. E., & Taylor, K. (2017). Aulton's Pharmaceutics: The Design and Manufacture of Medicines. Elsevier. [Link]
  • FDA Guidance: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. [Link]

Lyophilization Cycle

  • Tang, X., & Pikal, M. J. (2004). Design of freeze-drying processes for pharmaceuticals. Pharm Res. [Link]
  • Kasraian, K., & DeLuca, P. P. (1995). The effect of TBA on the resistance of the dry product layer. Pharm Res. [Link]
  • Franks, F. (1998). Freeze-drying of bioproducts: principles into practice. Eur J Pharm Biopharm. [Link]
  • Pikal, M. J. (1990). Freeze-drying of proteins. Part I: Process design. BioPharm.

Operational Excellence & Optimization

  • Linear Programming: Dantzig, G. B. (1963). Linear Programming and Extensions. RAND. [Link]
  • Integer Programming: Wolsey, L. A. (2021). Integer Programming, 2nd edition. Wiley. [Link]
  • Portfolio Standards: PMI (2017). The Standard for Portfolio Management. [Link]
  • Resource Constraints: Goldratt, E. M. (1984). The Goal: A Process of Ongoing Improvement. [Link]

Restructuring & Decommissioning

  • EHS Compliance: EPA. (2023). Resource Conservation and Recovery Act (RCRA) Orientation Manual. [Link]
  • Asset Recovery: ISPE. (2021). Good Practice Guide: Asset Management. [Link]
  • Human Capital: DOL. (2023). WARN Act Worker Transition Guide. [Link]
  • Site Safety: OSHA. (2022). Safety and Health Topics: Demolition and Decommissioning. [Link]

Regulatory Defense Across Global Markets

Our programs are built for defense. We provide technical dossiers and strategy for the FDA, EMA, & PMDA, ensuring your CMC section is a source of strength in your NDA/MAA filing.

FDA EMA PMDA