Analytical Solutions to help improve your productivity and compliance to global regulations. Compliance Solutions to help you to achieve compliance to TGA, FDA, Medsafe, MHRA and Health Canada regulations. Regulatory Affairs services to help you expand your market.

Outsourcing and Consulting for Analytical, Compliance and Regulatory Services

PharmAssure is an outsourcing and consulting company providing expertise in pharmaceutical development and compliance activities, from initial product development through to compilation and support of regulatory submissions. Read more....

Consulting Services

Sometimes it is necessary to obtain advice from experienced practitioners in order to meet the regulatory requirements in the pharmaceutical industry. PharmAssure’s experienced consultants can help guide you in the right direction and partner with you to achieve the desired outcome. Some examples of where we could assist are:

  • Laboratory Health and Safety Systems
  • Solvent and/or Chemical Management/Segregation
  • Laboratory Workflow Design
  • Audit advice
  • Pharmaceutical Development
  • Calibration program design
  • Analytical Method Validation
  • Process Validation
  • Equipment Validation
  • System Validation

Outsourcing Solutions

PharmAssure’s outsourcing solutions means your lean workforce can continue to add value by performing their core competencies while the non-routine work is handled by competent professionals. Some examples of outsourcing solutions are:

  • Hazardous Substances Risk Assessments
  • Laboratory Documentation System
  • Internal Audit Programs
  • Equipment Validation
  • Pre-Inspection Audits
  • Management of Calibration Program
  • Validation Protocols and Reports
  • System Validation Packages
  • Master Document Design
  • Regulatory Dossier collation

Of course, all the areas where we can provide outsourcing solutions can also be delivered in a consulting capacity. Ask us how!