Engineering

We provide a full range of engineering services for pharmaceutical facilities including the development of conceptual and detailed engineering.

We carry out engineering of:

•Pharmaceutical warehouses

•Drug manufacturing

•Production of APIs

•Quality control laboratories

Training

The effectiveness of training is ensured by a high level of professional trainers. The entire process is harmoniously integrated into the existing QMS of the enterprise. All trainers are highly qualified practitioners.

Qualification

The qualification of equipment and service systems is based on a risk analysis. Based on the risk analysis, the list, the scope of the tests and the frequency of the requalification are determined.

We carry out:

• Validation masterplan

• Design qualification

• Installation qualification

• Operational qualification

• Performance qualification

Validation

To ensure high quality of medicines and confirm the process performance, we perform process validation, cleaning validation and computerized systems validation. The validation is based on a risk analysis.

We carry out:

• Process validation

• Cleaning validation

• Validation of computerized systems

Marketing Authorisation

We carry out preparation of an application for a marketing authorisation dossier to authority and carry out the full support.