“Involved in our customers increase of value” Approach to the Industry Global Support Member of regulanet® www.regulanet.com

A Spanish capital owned company ….by a group of experienced proffessionals with years in the Pharmaceutical industry A Spanish capital owned company A memeber of the biggest pharmaceutical industry regulatory and PV services company with European base The most experience supporting team in the territory With reliable reference and success client examples Member of regulanet® www.regulanet.com

RA CRO OUT STRATEC PLACEMENT Pharma Executive Education Member of regulanet® www.regulanet.com

RA REGULATORY AFFAIRS Working at an international level with the world leading pharma companies Giving RA support to small, mid sized and big pharma companies …..as a global RA external dept …..at the highest qualification level …..today with about 20yrs of experience …..and a qualified team specialized in medicines, fs, md, cosmetics Working with the top leading technology, in RA, safety, and data security Member of regulanet® www.regulanet.com

RA REGULATORY AFFAIRS A «GLOCAL» (Global + Local) company with the right international partners worldwide With presence in LATAM registering products in most of the continent countries As a representative partner for a Danish DB company (TARIUS) Reporting the updated regulatory guidelines from Chile Ecuador, Peru, Colombia, Mexico, and forth coming countries in the next years. And with regulatory operations in the whole EU including EEC countries, CIS and MENA countries. Member of regulanet® www.regulanet.com

PV PHARMACOVIGILANCE QualitecFarma is the QPPV/Local Contact for many pharma companies both at a local level and for international companies. Internal PV system according to latest regulations and ISO9001/2008 certification granted 2016 by AENOR/IQnet 2 people certified by the EMA as EUQPPV Supporting the global PV activities XVMPD, literature search, ADR management and DataBase Data security protection and certified fireproof remote archive Member of regulanet® www.regulanet.com

CRO CLINICAL RESEARCH Member of regulanet® www.regulanet.com

CRO CLINICAL RESEARCH GLOBAL SUPPORT IN CLINICAL RESEARCH (CRO) CLINICAL TRIALS PHASE I TO PHASE IV PHASE 0 STUDIES OR TRANSLATIONAL OBSERVATIONAL AND EPIDEMIOLOGICAL STUDIES CLINICAL DEVELOPMENT PLAN BIOTECHNOLOGICAL PRODUCTS AND MEDICAL DEVICES COSMETICS Y FOOD SUPPLEMENTS Member of regulanet® www.regulanet.com

CRO CLINICAL RESEARCH Member of regulanet® www.regulanet.com Study design (including statistics) Protocol preparation and writing CRD design. Electronic support if required Dossier of the study Protocol submission and amendments to CCAA, AEMPS and CEICs Contract management with hospitals and CCAA Biostatistics and data management • Monthly and Annual reports preparation • Drug and study materials distribution • Investigators Meeting organization • Brochure and Newsletters preparation • Assistant to the Investigators Meetings • Payments to the Investigators, Centers, others • Project coordination and supervision • Implementation and maintenance of the archive (TMF/TCFs/IFs) • Site selection • Initiation, Follow-up and Close-up visits • Notification and follow up of SAEs • Centralized registry of the patients and randomization Member of regulanet® www.regulanet.com

Experience in a wide range of therapeutic areas with medicinal products/medical devices, as well as of diagnostic, procedure and chart review studies.

Expertise and management of trials from Phase I to IV, specially in early development.

Therapy Area Studies Oncology (gene therapy) 4 Gastrointestinal Diseases 3 Transplantation Liver diseases 2 Woman’s Health Kidney disease Dermatology Metabolic disorder (gene therapy) 1 Hypertension Respiratory (pediatric) Pediatric pain Surgical suture Other TOTAL 25 TRIAL Studies Patients Phase I 6 296 Phase I/II 128 Phase II 7 855 Phase III 8 1,015 Registry-IV 1 Medical Devices 50 Other 2 195 TOTAL 31 2,547

INDICATION TYPE OF STUDY PATIENTS SITES COUNTRIES INVOLVED STAGES OF STUDY INVOLVED (E.G. SET UP TO END, JUST CLOSE-OUT ETC.) Healthy volunteers I 46 1 Bulgary Full services (Protocol preparation, initial visit, monitoring overseen and close out including CRS review. Control about timelines and budget) 30 2 Spain Overseen product manufacturing and GMP batches. Subcontracting animal models experiments and GLP toxicology package. IMPD preparation and submission. Protocol development, selection sites, overseen the CRO on charge until CRS delivery. Control about timelines and Budget. 36 Overseen product manufacturing and GMP batches. Sucontracting animal models experiments achievement and GLP toxicology package. IMPD preparation and submission. Protocol development, selection sites, overseen the CRO on charge until CRS delivery. Control about timelines and budget 50 Lead CRA on charge from start up to the end. 80 Infectious disease 54 Protocol preparation, initial visit, CRA monitoring overseen and close out including CRS review Oncology (gene therapy) I/II 12 IMPD preparation. Initial visit, review monitoring reports, sites issues and close out visits. Main contact with the sponsor. 8 Oncology (ex vivo therapy) IMPD preparation. Initial visit, review monitoring reports, sites issues and close out visits. Main contact with the sponsor Liver diseases 10 Overseen some tox studies, prepare the IMPD and from start up to the end concerning the clinical trial II 20 Lead CRA on charge from start up to the end Metabolic disorder Observational Set up to the end Metabolic disorder (gene therapy) 4 Spain, Germany and Sweden Neurological. NPP. csi Set up to the end. Woman’s Health 400 5 Europe (?) Protocol development and feasibility study 100 Germany Protocol development IBD III This activity is currently ongoing Gastrointestinal disease Preclinical - Subcontracting animal models experiments and GLP toxicology package. IMPD preparation and submission. Overseen product manufacturing and GMP batches. CDP advice. Protocol development, selection sites, overseen the CRO on charge until CRS delivery. Control about timelines and Budget. Kidney disease 150 29 Answering questions and take actions after Spanish Regulatory Agency inspection to 5 participating sites 210 21 Spain, The Netherlands and Czech Republic Start up, monitoring support to 9 CRA Dermatology OLE 95 17 Spain, UK, Poland, Italy, Hungary and Germany Open Label Extension (OLE). Protocol development, selection sites, overseen the CRO on charge until CRS delivery. Control about timelines and budget Protocol development, selection sites, overseen the CRO on charge until CRS delivery. Control about timelines and budget PRO USA Patient Reported Outcome (PRO) development Oveerseen the American CRO to identify items, prepare the PRO and validate in patients 120 18 Spain and Italy Site identification, initial visits, review monitoring reports, sites issues and close out visits. Main contact with the sponsor. Control about timelines and budget Metabolic disorders 300 15 Start up, monitoring, queries resolution and close out Hypertension 45 3 Lead, support and interact with CRAs to manage site activities Respiratory (pediatric) Patient Reported Outcome (PRO). Monitoring Pediatric pain 40 Kidney transplantation Just protocol preparation, submission and answering question. 60 6 Spain and Portugal Lung transplantation Surgical suture Medical Device Protocol design and submission

GMP GMP COMPLIANCE Leaded by a 25 years of experience directive, this unit has helped many companies to comply with the quality requests of the EU market CSV Data integrity Serialization IT quality system SOPs VALIDATION/QUALIFICATION Clean rooms Equipment Cleaning Manufacturing process Anlyticalmethods Risk analysis GDP Transport rutes validation Cold chain Logistic operator management euGMP implementation Audit plan Organization and team structure GMP philosophy Training Certifications and HA audits

Since 2011 PharmaExecutive Education® Joint Venture between QualitecFarma and the Fourm Institut Für Management To offer executive short sessions To professionals In the area of pharma industry business Member of regulanet® www.regulanet.com

Corporate Business Operations STRATEC STRATEC® Corporate Business Operations Managed by a Former General Manager of different multinational pharma companies, Actavis, Dr. Reddy´s, Pliva etc. and experienced for more than 30 years. Including merger & acquisition company processes Portfolio management and company structure advice and development Product launch and access to market Crowd funding and R&D capital search Member of regulanet® www.regulanet.com

New Challenges….. RA PV TRAINING GCP ISO9001/2015 ISO27001 Data protection ISO9001/2015 Certified June 2017 Member of regulanet® www.regulanet.com

The solid partner for the new pharmaceutical challenges……… …..a wide extended range of global services for the Bio-Pharmaceutical industries….. The solid partner for the new pharmaceutical challenges……… Member of regulanet® www.regulanet.com