network managment of pharmaceutical development, regualtory affairs and market access

Member of regulanet®

© 2013 Farmavita Regulanet Ltd. 1

Your local guide for complex international journeys

International Regulatory Affairs

and Market Access

Member of regulanet®

© 2013 Farmavita Regulanet Ltd. 2

Scope of services

Member of regulanet®

© 2013 Farmavita Regulanet Ltd. 3

Project management

Preclinical development

Pharmacovigilance

Regulatory affairs

Market Access

Drug discovery

Preclinical development

Clinicaltrial phase

Drug approval Marketing

Pharmaceutical development

Clinical development

Strategic Regulatory affairs

Services Over Supply Chain

Portfolio Management

Member of regulanet®

© 2013 Farmavita Regulanet Ltd. 4

International Human Capital

regulanet ®

250+ staff and associates

FarmavitaR+ RA Community (www.farmavitar.com)

1000+ registered users worldwide

JV PartnersGermany; England, Croatia; Portugal;

FarmavitaR+ 30+ staff and associates

FarmavitaR+ covering 15 countriesEU – Czech, Slovakia, Hungary, Slovenia, Croatia, Bulgaria. RomaniaNon-EU – Turkey, Ukraine, Serbia, Bosnia&Herzegovina, Montenegro, Macedonia, Kosovo, Albania

regulanet® covering 90 countries Rest of EMEA, USA, Japan, Brazil, Russia, India, China, Canada, GCC countries, Mercosur countries, Africa

Our talent pool, worldwide

Member of regulanet®

© 2013 Farmavita Regulanet Ltd. 5

In-house vs. out-sourced

In-house Out-sourced

Infrastructure costs (offices, utilities, equipment, software)

Yes No

Recruiting costs Yes No

Staff training costs Yes No

Support functions costs (accounting, human resources, legal support, maintenance/cleaning)

Yes No

Redundancy costs Yes No

Fixed salary costs Yes No

Simple monitoring of performance Sometimes Yes

Overall costs linked only to performance No Yes

Easy scale-up/scale-down of operations No Yes

Member of regulanet®

© 2013 Farmavita Regulanet Ltd. 7

Contact

Farmavita Regulanet Ltd.

Okicka desni odvojak 2,

10430 Samobor

Croatia

Phone: +385/1/3377-058

Fax: +385/1/777 6314

info@farmavitar.com

www.farmavitar.com