Converge to Emerge

Avista Research

About Avista Research

Avista Research is a vertically integrated company whose expertise arises from a broad range of demonstrated capabilities in all areas of small molecule pharmaceutical research and development.

  • <12MONTHS from NOMINATION to IND
  • 48%Ph.D. SCIENTIFIC STAFF
  • 67%15+ YEARS EXPERIENCE
  • 20IND CMC SUBMISSIONS

Specialties

Drug Substance Development Capabilities

  • Discovery chemistry intermediates and analogs preparation from milligram to kilograms scale
  • Custom synthesis
  • Route discovery, selection and definition
  • Process improvement and optimization
  • Robustness and process limits testing
  • Synthesis of analytical reference standards
  • Metabolite, degradent and impurity synthesis
  • Quality by Design (QbD) process evaluation
  • Statistical Design of Experiments (DOE)
  • Process scale-up and demonstration
  • Preparation of intermediates and regulatory starting materials
  • Preparation of active pharmaceutical ingredients under cGMP controls
  • Technology transfer to commercial scale
  • Solid state chemistry –salt selection, polymorph screening, amorphous dispersions, crystallization development

Drug Product Development Capabilities

  • Discovery and GLP formulation optimization
  • Pre-formulation
  • Excipient compatibility
  • Efficient first in human formulation selection
  • Expertise in developing enabled formulations for poorly soluble API’s
  • Formulation development for solid oral and parenteral formulations
  • Powder in capsule and powder in bottle cGMP manufacture
  • Custom packaging and labeling
  • Technology transfer of manufacturing processes to cGMP manufacturers

Analytical Development Capabilities

  • Phase appropriate analytical method development and validation
  • Impurity isolation, identification and structure elucidation
  • Preparative chiral and achiral chromatgraphy (LC, SFC)
  • Materials characterization and release testing
  • Pre-glp bioanalytical analysis
  • Dose formulation analysis
  • Reference standards and impurity qualification
  • Pgti identification and method development
  • ICH stability studies
  • Extractable and leachable studies

Regulatory

  • CMC Quality eCTD module documentation for IND and IMPd dossier submissions

Quality Management System

  • Comprehensive Quality Agreements
  • Phase appropriate cGMP
  • Utilization of quality risk management principles
  • Commitment to quality and continuous improvement

Integrated Phase Appropriate Development Platform

News

Specialized cGMP Facility for Manufacturing of Clinical Trial Material

Contact

Avista Research

2620 Trade Center Avenue
Longmont, CO 80503

Contact:

info@avistaresearch.com