Projects of our team

FRESENIUS, Dubna, Moscow region, Russia
Production of dializers
Project Management and Construction Supervision. Conducting GMP Risk Analyses (GMP RA) and Design Qualification (DQ).

NYCOMED, Kyev, Ukraine
Finished pharmaceuticals production
Conceptual Design of a new production facility: master-plan, layout solutions, clean utilities, GMP concept, documentation management.

NIKO, Donetsk, Ukraine
Intravenous Solutions
Conduction of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of two BFS filling systems.

OLAINFARM, Rīga region, Latvia
Solid dosage forms and API production
Conduction of Computerized Systems Validation (CSV) / implementation of GAMP 5 life-cycle for computerized control systems in the API production area.

TAKEDA, Põlva, Estonia
Finished pharmaceuticals production
Conceptual Design of facility reconstruction. Validation Master Plan (VMP), GMP Risk Analyses (GMP RA) and Design Qualification (DQ).

TAKEDA (NYCOMED), Yaroslavl, Russia
Finished pharmaceuticals production (solid and injectable forms)
Conceptual, Basic and Detail Design. Project Management and Construction Supervision. Regulatory Management / Approvals. GMP Risk Analyses (GMP RA), Design Qualification (DQ), Installation and Operational Qualification (IQ/OQ) for clean utilities and HVAC / cleanrooms. Performance Qualification (PQ) for pharmaceutical water systems.

BERLIN-PHARMA / MENARINI, Kaluga region, Russia
Finished pharmaceuticals production (solid forms)
Conceptual, Basic and Detail Design. Project Management and Construction Supervision. Regulatory Management / Approvals. GMP Risk Analyses (GMP RA), Design Qualification (DQ), Installation and Operational Qualification (IQ/OQ) for clean utilities and HVAC / clean rooms.

RGCC, Baar/Zug, Switzerland
Center for Genetic Research of Cancer
Conceptual Design for Cytostatics QC Laboratory and packaging facility.

RGCC, Steinhausen/Zug, Switzerland
Center for Genetic Research of Cancer
Conceptual Design for solid and semi-solid forms manufacturing facility and distribution warehouse.

BZMP (Borisov Pharmaceutical Plant), Borisov, Belarus
Solid forms and injectables
Environmental GMP-Monitoring System (EMS) Tarqvara for clean rooms in aseptic filling production building.

APTOS, Tbilisi, Georgia
Medical Devices (Surgery Materials) Production
Conducting GMP Risk Analyses (GMP RA) inline with ISO 14971.

GERAPRAKTIKA, Vilnius, Lithuania
GMP/Pharma Competences and Events Center
Conducting training webinars for Clients of the Center. Preparation of training materials and presentations at conferences.

ACINO Estonia OÜ, Põlva, Estonia
Finished pharmaceuticals production
Contract packaging transfer project management for Acino Group and their international Clients.

GILSiNP, Moscow, Russia
State Institute of Drugs and Good Practices, Pharmaceutical Inspectorate
Conducting training seminars and webinars. Computerized Systems Validation (CSV) for IT systems of the Institute and Inspectorate.

FORT, Ryazan region, Russia
Biotechnological pharmaceuticals production
Project Review, conducting GMP Risk Analyses (GMP RA) and Design Qualification (DQ).

GEDEON-RICHTER, Shuvoye, Moscow region, Russia
Finished pharmaceuticals production
Installation and Operational Qualification (IQ/OQ) of pharmaceutical water generation, storage and distribution system (PW and WFI).

ASTRA ZENECA, Kaluga region, Russia
Finished pharmaceuticals production
Conceptual, Basic and Detail Design. Project Management and Installation Supervision. Regulatory Management / Approvals. Fire and explosion hazard category calculations.

VALENTA, Shchelkovo, Moscow region, Russia
Finished pharmaceuticals production
Pharmaceutical water generation, storage and distribution system, CIP and Solution Preparation systems: GMP Risk Analyses (GMP RA), Design Qualification (DQ), Installation and Operational Qualification (IQ/OQ). Computerized Systems Validation (CSV) for Solution Preparation Control Systems.

TEVA, Yaroslavl, Russia
Finished pharmaceuticals production
Development/configuration of Environmental Monitoring System (EMS). Installation and Operational Qualification (IQ/OQ) for clean utilities, HVAC units / clean rooms, de-dusting system and Environmental Monitoring System (EMS).

RGCC, Florina, Greece
Center for Genetic Research of Cancer
Sterile and OSD Cytostatics production: Conceptual and Basic Design. GMP consulting, development of URS, conducting audits/FATs, Qualification/Validation. Environmental monitoring system Tarqvara GMP Monitor for clean rooms and main equipment. Laboratory and manufacturing facility for cosmetics and personal medication: Conceptual Desing and GMP consulting.

TALLINNA FARMAATSIA TEHAS, Tallinn, Estonia
Finished pharmaceuticals production
GMP and containment consulting for highly potent drugs, Design Review, GMP Risk Analyses (GMP RA) and Design Qualification (DQ) for a new production of ointments/crèmes with hormones.

GENERIUM, Vladimir region, Russia
Biopharmaceutical production
Conducting GMP Risk Analyses (GMP RA) and Design Qualification (DQ) for a tablets production. Design Review, GMP Risk Analyses (GMP RA) and Design Qualification (DQ) for a new biotechnological API production facility.

MICROGEN, Ufa, Russia
Biopharmaceutical production
Conducting GMP Risk Analyses (GMP RA) and Design Qualification (DQ).

CONCEPT HEIDELBERG, Heidelberg, Germany
GMP/Pharma Competences and Events Center
Review and correction for Russian version of GMP-training courses.

NATIVITA, Vitebsk region, Belarus
Cytostatic drugs production
Development of Conceptual Design, conducting GMP Risk Analyses (GMP RA) and Design Qualification (DQ) for environmental GMP-monitoring system.

ACINO INTERNATIONAL AG, Zürich, Switzerland
Finished pharmaceuticals production
Technical Due-Diligence audit of a potential contract manufacturer for Acino Group.

ACINO PHARMA AG, Aesch/Basel, Switzerland
Development of printed packaging materials Artwork (AW) for Acino Group.

SQA SERVICES INC, California, USA
Global supplier of GMP/Pharma competences
Conducting GMP, GDP and ISO audits on behalf of big multinational pharmaceutical manufacturers.