8809 Ely Road
Pensacola, Florida 32514

850.478.2770

Contract Development of Companion Animal Products

Innovators come to us. We go to work.

Pegasus Laboratories, Inc. is a Full-Service Contract Development and Manufacturing Organization (CDMO)

What is a CDMO? As a full-service Contract Development and Manufacturing Organization, Pegasus Laboratories partners with organizations to advance their innovations, providing all phases of product development and manufacturing.

Pegasus Laboratories is a full-service turn-key CGMP facility that can take a product concept to commercialization. Offering industry-leading technical expertise, state-of-the-art manufacturing and laboratory facilities, and personalized customer service, we guide our partners from ideation, through research and development, testing, and regulatory requirements, manufacturing and launch.

Research and Development

Research and Development Services include:

  • Pre-formulation
  • Formulation Development & Support
  • Analytical Development
  • Process Design and Development
  • Stability Studies
  • PK Support
  • Development of Chemistry and Manufacturing Controls
  • Licenses and certifications: DEA, FDA, EMA, Health Canada, Japan, and Australia

Scale-up and Technology Transfer

Complete Validation Services

  • Microbiology Support
  • Analytical Test Method Development and Validation
  • Engineering Support, Scale-up, and Process Design
  • Equipment Commissioning and Qualification
  • Pilot and Full-Scale Stability Studies
  • Process and Packaging Validations
  • Cleaning Validations

Clinical and Commercial Manufacturing

A seamless operation, Pegasus meets partner manufacturing needs from development through commercialization in a variety of dosage forms, including:

Solid Oral Dosage Forms

  • Custom Formulations Designed to Client Requests
  • Process Engineering and Scale-up
  • Pilot Studies and Clinical Batch Production
  • Full Validation Services
  • Compounding; Individual Lot sizes up to 1,800 kg
  • Custom Packaging Configurations available
  • Tablets, Boluses, Granulation and Direct Compression for lot sizes up to 2,000 kg

Topical & Semi-Solid Dosage Forms

  • Custom Formulations Designed to Client Requests
  • Process Engineering and Scale-up
  • Pilot Studies and Clinical Batch Production
  • Full Validation Services
  • Compounding; Individual Lot sizes up to 4,000 kg
  • Custom Packaging in the Following Configurations:
    • Tubes (3 gm to 300 gm)
    • Bottles (1 oz. to 1 gal.)
    • Pen Applicators
    • Metered-dose delivery systems
    • Vials up to 100 mL
    • Custom packaging configurations available

Liquid Oral Dosage Forms

  • Custom Formulations Designed to Client Requests
  • Solutions, Suspensions & Emulsions
  • Process Engineering and Scale-up
  • Pilot Studies and Clinical Batch Production
  • Full Validation Services
  • Compounding; Individual Lot sizes up to 4,000 kg
  • Custom packaging in Bottles, Syringes, and Other Packaging Configurations

Support Services

At Pegasus Laboratories, we are focused on helping our partners meet their regulatory and validation needs in today’s strict regulatory environment. Support services for our clients include:

Project Management
  • Experienced in management of complex projects
  • Committed to delivering exceptional customer service
  • Flexible, responsive, and focused on client success
Quality Control
  • Raw Material Testing
  • Finished Product Testing
  • Stability Testing
  • Fully Equipped Laboratory for Project Support
Quality Assurance
  • Document Control
  • GMP Training
  • Pharmacovigilance
  • Annual Product Reviews
  • Change Management
Regulatory
  • Drug Listings (FDA-SPL)
  • NADA/ANADA filings
  • Chemistry, Manufacturing and Controls (CMC)
  • Design and Oversee Clinical Trials
  • Target Animal Safety
  • Vendor Audits