knowledge associates

Life Science Consultants.

Business. Facilities. Quality. Compliance.


Your strategic Life Science business partner

Market Analysis and Life Science Business Strategy.

Product Portfolio Creation and Management.

Business Strategic and Tactical Planning.

Decision Optimisation.

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.


We have

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.


email david.paspa@knowledgeassociates.asia

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?

Experience

We have over 27 years of experience in international GMP regulated industries.

Secure

We value the trust our clients place in us extremely highly and take confidentiality very seriously.

Fundamental Science

Our approach is pragmatic and simple. Anybody can understand it, even with no prior GMP knowledge.

Measurement

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


Maintain
information
certainty


PIC/S, EU and US FDA
compliance


Risk
based
decisions


Eliminate
doubt and
waste


Capacity
balanced
improvements


Quality
improvement
focused

Lean Compliance

We apply the principles of Lean and Six Sigma to your process design and quality and compliance efforts and Systems Theory to your overall business management.

This results in sharp focus on the points of greatest leverage in your business.


Increased Velocity

This focus and "less is more" approach increases the rate at which your organisation improves.

We are business professionals and engineers.
We understand the detail complexity "under the hood" of your facilities, systems and processes, as well as the system level dynamic complexity of your overall business.

Let us help you become the world's number one Life Science business.