STERILE SOLUTIONS

FORMULATIONS

  • ​​​​Solutions

  • Ointments

  • Gels

  • Suspensions

  • Emulsions

DOSAGE FORMS

  • ​​​​Nasal

  • Topical

  • Oral

  • Injectable

  • Ophthalmic

RESEARCH & DEVELOPMENT SERVICES

  • Pre-formulation & Formulation development

  • Analytical development and validation

  • Spray Characterization method development and validation

  • Process development and validation

  • Clinical Trial Material Manufacturing

  • Stability studies: ICH and custom

  • QbD Services

    • Formulation

    • Process Development

    • Scale-up

EQUIPMENT, CLEANING & STERILIZATION VALIDATION SERVICES

  • All cGMP / cGLP Equipment IQ/OQ/PQ

  • Facilities / Utilities / Environments IQ/OQ/PQ

  • Feasibility / Machinability Studies

  • Cleaning Process Development / Validation

  • Sanitization/Sterilization Process Development / Validation

  • API/Bulk Sterilization Process Development / Validation

  • Process / Packaging Validation

  • Continued Process Monitoring

  • In-Process Holds / Processing Times

  • Sterile Process Simulations

  • Container Closure Studies

  • Filter Validation

PACKAGING SERVICES

  • Identification and Sourcing Services

  • Specification Development

  • Dose Volume Evaluation

  • Drug/Package Compatibility

  • Commercial Scale Fill and Finish Assessment

  • Equipment Sourcing, Design, Engineering, Qualification, and Validation

  • Serialization

SUPPORT SERVICES

  • Project Management

  • Quality Systems (Quality Control and Stability)

  • Quality Engineering

  • Regulatory Affairs Support

  • Procurement Group