Consulting

We will ensure that your operations are in compliance with the requirements of GMP and FDA now and in the future

There are multiple requirements concerning cleanrooms, equipment and systems. With our help you can recognize and implement them rationally and efficiently.

Our experts offer consultation for companies on all issues concerning GMP requirements, taking into account commercial and economic viewpoints. We are familiar with all the related international regulations, requirements of the authorities and the operating environment of companies.

We have knowledge and perspectives to share in every phase of the life-cycle. Equipment and system providers of GMP and Medical Device sectors have received our consultation starting from early-phase equipment development and product realization of validation to distribution and maintenance of validation. We will assist in design and documentation, preparing for audits and inspections, risk analysis and quality control.

Smart Compliance of GMP requirements

• Validation
• Product realization of validation
• Maintenance of validation
• Life-cycle management
• Data Integrity

ISO 13485 Medical Device

• Development of a quality system
• Equipment and system validations

Lean Six Sigma

We have provided consulting to numerous companies by helping them develop their operation and process quality. By rationalizing processes and shaving off the unnecessary parts you can eliminate waiting and provide lean services.

We are Lean Six Sigma Black Belt certified.

• Made to order process
• Streamlining of processes
• Creation of value
• Customer satisfaction

Expert consultation

First we map out and assess the initial situation, and then we form a view of the best solution required by the situation.

When you need help concerning validation in any part of the life-cycle, please contact us to ensure the compliance of your products, processes and equipment today and in the future.