The CERASP offers a wide range of services, both technically and at the regulatory level. These services may be the development of a new product or the design of a new procedure for a customer. They can also aim at improving an existing product such as changing the color or the taste for example.

This notion of improvement is also valid in the case of a deficient or obsolete procedure for regulatory reasons, hence the need for companies to comply with the regulations in force.

State-of-the-art
offering

We offer the following services:

PRODUCT DEVELOPMENT

CEGEPs

  • Creams, pastes, lotions, ointments, non-GMP tablets

NEOMED

  • Biopharma: preformulation, formulation, upstream and downstream processes, development of analytical methods

BUSINESS DEVELOPMENT

Grants & Funding Strategies

  • Business plan and strategy development
  • Equipment acquisition
  • Molecule development

New Product Introduction

  • Project management
  • Business plan creation
  • Operation, location and resource management
  • Operations design and implementation of new GMP/GLP installations

VALIDATION, OPTIMIZATION AND TECHNICAL SUPPORT

  • Validation of pharmaceutical technique: processes, equipment and cleaning
  • Optimization of processes: production, quality, supply chain
  • Lean Six Sigma methodology: organization of work flow, material and personnel entry, continuous improvement, 5S, waste and cost reduction
  • Writing Standard Operating Procedures (SOPs)
  • Audit preparation: coaching, updating plans and documentation and presenting to auditors
  • Preparing risk mitigation plans

TALENT DEVELOPMENT AND HANDS-ON TRAINING

Talent, Business, Technical Skills and Competency Building

  • Leadership and team development programs
  • Managing change: leadership approaches to change, how to manage change and assure it is sustainable
  • Lean Six Sigma methodology: problem-solving, continuous improvement, 5S and waste reduction
  • Scientific knowledge: microbiology, pharmaceutical production for support services, working supports, working under laminar flow and in aseptic zone
  • Production processes and trouble shooting
  • Supply chain and cold chain process
  • Quality: validation, quality assurance, quality control, deviations and CAPAs
  • Audits: how to prepare for an inspection and avoid non-conformity comments or citations

 

For more information, contact us by email: info@cerasp.ca