Our deep knowledge about national and international regulations combined with our technical insight makes it possible for us to find the right level of compliance in an effective way and with approved inspections as the result.
Validation and project quality planning is one of our core competencies. We ensure that the planning matches the needs of the project and complies with the expectations of the authorities.
We are experienced in creating quality management systems like ISO 9001, ISO 27001 supporting the needs of your business, reflecting the optimal processes for your operation.
We have a well-proven track record, when it comes to project management.
We have completed everything from minor change requests to work packages in large green field projects. In medium-sized projects we often take advantage of our hybrid profiles to perform both project management and engineering services
with a single resource to reduce the total amount of hours spent.
We also take care of management of vendors and suppliers and follow up on their deliveries, time schedule, budget and quality always keeping
the projects overall goal in focus.
We are especially strong when it comes to IT and Automation and we always manage to implement IT and Automation to support every process from API production through Wash & Sterilization, Clean Utilities, HVAC, Aseptic production to Packaging and Serialization.
We support customers creating requirement specifications, writing design documents, interface agreements, etc. for various processes and systems.
Mostly we support our customers with review of supplier design documentation and performing design review sessions ensuring that the proposed solutions are compliant and fulfils the customer requirements.
We have many years of first hand experience with pharmaceutical production.
In project we always use our production experience to implement the solutions which supports the production in the best possible way.