Market Analysis and Life Science Business Strategy.
Product Portfolio Creation and Management.
Business Strategic and Tactical Planning.
GMP and validation Consulting, Training and Auditing.
Product Dossier Registration and Regulatory Liaison Services.
Constraint Management and Throughput Maximisation.
Concept, Basic and Detailed Design for greenfield and brownfield facilities and upgrades.
Project and Construction Management.
Commissioning and Qualification Management.
Client Representative Services to assure the success of your project.
Trained GMP regulators from 5 different countries.
Worked on more than 100 projects for more than 60 customers from Asia, Australia, Europe and the U.S.
Been involved in facilty design and construction projects across 5 continents.
Worked in Operations for Multi-National Corporations.
Validated process equipment, utility plants, product and cleaning processes, laboratory equipment.
Designed IT Architectures and performed Computerised Systems Validation.
Implemented holistic Quality Management Systems.
Regulated industries are filled with uncertainty.
What is actually required?
How much is enough?
What will the Auditor focus on?
What is 'best' practice?
There are many things to be done
in pursuit of your business goals
Some regulations help you achieve them.
Some do not.
Some businesses have become distracted by their interpretation of the regulations
This is evidenced by the vast extent of compliance activities they put in place and yet they continue to have compliance issues and "audit stress".
Your business should be driving your compliance activities, and not the other way around
Signs that compliance activities are driving your business
Compliance requirements seem to be a moving target
More and more resources are tied up and costs escalate
No product quality or bottom line improvement
What if compliance worries just disappeared?
We have over 27 years of experience in international GMP regulated industries.
We value the trust our clients place in us extremely highly and take confidentiality very seriously.
Our approach is pragmatic and simple. Anybody can understand it, even with no prior GMP knowledge.
We provide a clear and unbiased assessment of your current business and compliance status and what you need to do to improve.
The hard parts made easy
PIC/S, EU and US FDA