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

2. 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®

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

4. 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®

5. 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®

6. 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®

7. CRO
CLINICAL RESEARCH
Member of regulanet®

8. 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®

9. 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®

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

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

12. 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

13. 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

14. 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

15. 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®

16. 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®

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

18. 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®