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Content 1. 2. 3. 4. 5. 6. 7. About us Mission & Vision Values Facility Quality Management System Services Why PCS

About us

Mission and Vision Mission Based on knowledge, experience and a desire to strive for excellence we offer our customers the most innovative, flexible and top quality solutions in the pharmaceutical industry, focusing particularly on logistics for clinical trials. Vision Our vision is to become the leading company in Poland providing comprehensive solutions for the pharmaceutical industry. We want to combine the power and capabilities of a large conglomerate with simultaneous flexibility of a small company.

Values Passion I Commitment I Success We work with passion and commitment for our client’s success

Facility PCS warehouse is located in Duchnice only 15 km from Warsaw city center. Specially equipped warehouse of class A fulfills the requirements of Good Manufacturing Practice. Main advantages of the location: q travel time to Warsaw is approximately 25 minutes during peak hours q travel time to the airport is approximately 20 minutes during peak hours q good connection to capitals of neighbour countries

Zaplecze logistyczne

Zaplecze logistyczne

Warsaw 22 th April 2013 9

Quality Management System PCS operates in accordance with the applicable legal guidelines and regulations relating to Quality Management Systems, in particular with the requirements of GMP, GDP and GCP. Our efforts to continuously improve upon high quality service includes focusing on the risk management processes, as well as key quality management processes such as: • effective supervision of withdrawals / holds outstanding annual reviews of the quality of products • change management • management of deviations • corrective / preventive actions (CAPA) • qualification of suppliers • processes carried out regularly qualifications / validation • oversight of the process complaint

Quality Management System In accordance with the GMP requirements PCS has all necessary qualifications and validations, including validation of premises, equipment and employees. The objectives of the quality policy adopted in PCS are implemented through: • implementation and continuous improvement of the quality management system • quality control at every stage of each activity • high competence and independence of Qualified Persons • use of validated ERP class IT system • involvement of all employees to maintain high quality services

SERVICES

Transport For Sponsors, CRO’s and Research Institutes we offer transportation services of pharmaceutical goods under controlled temperature regime throughout Europe.

Transport We use trucks equipped with modern cooling devices for pharmaceutical cargo transportation under temperature regime 2°C – 25°C. Cooling devices are duplicated and works independently. All vehicles are also equipped with satellite tracking system (GPS). GPS satellite system enables, tracking shipments in transit, that is, online monitoring of the current location of the goods at any time of the transport process. Safety and quality of transport in all transport processes is enhanced this way, with emphasis on punctuality.

SERVICES

Distribution • PCS has a highly efficient distribution • PCS offers quality and reliable service network within Poland, Baltic and using the fleet with temperature Central European countries. Shipments conditions 2°C – 25°C. in this region can be done within maximum 48 hours. • We also guarantee temperature conditions up to minus 70°C (dry ice) • Distribution to most other countries of using thermoboxes to transport deep continental Europe is also possible frozen products (ex. blood). within maximum 72 hours. • Track and Trace - product traceability from acceptance to delivery.

SERVICES

Scope warehouse services Range of services in Manufacturing Plant is being offered in all temperature zones: ambient and cold. • Storage of: - Used and unused Investigational Medicinal Products - Medical devices - Labkits - Biosamples • Qualified Person services including releasing of investigational medicinal products in accordance with Good Manufacturing Practice • Packaging, repackaging, labeling, • Destruction • Preparation of ID number lists for Investigational Medicinal Products • Conducting of bioequivalance and biosimilar clinical trials

Monitoring Service according to ICH GCP compliance Regulatory Affairs: - Regulatory submission - Submission to Ethics Committees - Translation and validation of clinical trials documents in local languages - SUSARs and ASURs submission Project Management: set up of the study, management during the study and close out including final reporting. Monitoring: - Planning, oversight and administration of the clinical sites - Feasibility, Pre-study visits, Monitoring visits, Close-put visit Investigators/hospitals contracts and payment Preparation and conducting of investigator meeting

Why PCS q Over 20 years of experience in pharmaceutical business of it's founders, allows to use of the customer potential, solving at the same time all the emerging issues. q Meeting of all customer needs in order to ensure the complete and professional service in accordance with the requirements and expectations. q Always ready to implement solutions „built to suite„ if they provide increased efficiency and lower costs for the customer. q Wide range of pharmaceutical logistics services in one company.

Why PCS q PCS is compliant to international standards and systems: - GMP and GDP compliant - SOP governed - Compliance and certification of local requirements q We are proud of our services but still constantly improving. q Choosing the right partner for clinical trials logistics is a natural and critical issue when planning growth and development. PCS is your choice

Contact details: Lukasz Nowaczek - Business Development Director T: +48 515 042 521 Mail: lukasz. nowaczek@pcsolutions. pl Pharma Complex Solutions LLC Ożarowska 40/42 05 -850 Duchnice, Poland