Our expertise and integrated approach to concept design, compliance management, cGMP’s and all verification and operating programs in the life sciences/pharmaceutical industries allows;
- Compliance to all required regulations
- Compliance to project budgets and schedules
- Sustained compliance throughout the lifecycle of your process or facility
Our services include, but are not limited to:
Concept Design and Risk Assessment
We provide clarity and a fresh perspective, with an in-depth understanding of all the true requirements of a project.
We employ a risk based approach to concept design, relying on our experience to prioritize design attributes and provide fully functional facilities and processes.
Risk Assessment is also employed on existing systems to identify and prioritize potential risks. Risk mitigation often includes minor system changes, procedural changes and or enhancement to system maintenance and calibration programs.
We endeavour to use these risk assessment techniques throughout the system lifecycle, including verification and operations.
Whether it is commissioning a single piece of equipment or validating an entire manufacturing facility, our quality driven approach to all Commissioning, Qualification, Validation and Master Planning gains us the trust of our clients, who understand we have their best interests at heart. Our desire to always exceed expectations allows us to consistently complete our client’s projects on time and within budget. We have over 60 years of experience across a wide range of dosage forms, facilities, processes and equipment.
Our practical understanding of pharmaceutical and biotechnology facilities and processes coupled with an honest, fresh approach, allows us to integrate quickly with your existing programs and provide a clear outlook on your calibration and maintenance systems. In addition, our familiarity with many programs including risk assessment, computer compliance and site policies allows us to implement these important site programs and policies.
We have an in-depth knowledge of many pharmaceutical processes; this knowledge allows us to create accurate and compliant standard operating procedures.
Regulatory Compliance Management and cGMPs
We are cGMP experts. We have been engaged to assess many sites for overall compliance to the relevant industry standards. Our 3600 view of compliance allows us to identify the cGMP gaps and recommend practical resolutions. We also bring a fresh approach to training. We can design speciality programs for any cGMP related topic or we have a library of pre-produced materials from which you can choose.
Efficient project management can significantly reduce the total cost of a project. Our team of reliable consultants, approach all project management work with integrity, and ensure that we strictly manage risk, schedule and cost controls. This approach coupled with our strong work ethic ensures the project is delivered on time and within budget.
Our consultants bring over 60 years of combined experience in the areas of Concept Design, Risk Management, Commissioning, Validation, Compliance, and Quality Management, with a reputation for getting the job done, on time and within budget. Our in-depth understanding of the complete process from design, build, start up through to a fully operational facility will ensure the most cost effective approach is taken.
Our experience and knowledge allow us to provide a clear road map through the complex international regulations associated with today’s bio/pharmaceutical manufacture, including but not limited to FDA, Health Canada and EMA. Our clients can rest assured that their projects will be completed to industry best practices.