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International Regulatory Affairs
and Market Access

Your local guide for complex international journeys
© 2013 Farmavita Regulanet Ltd.

Member of regulanet®

1
Scope of services

© 2013 Farmavita Regulanet Ltd.

Member of regulanet®

2
Services Over Supply Chain
Drug
discovery

Preclinical
development

Clinical
trial phase

Drug
approval

Marketing

Project management
Pharmaceutical development

Preclinical development
Clinical development
Pharmacovigilance
Strategic Regulatory affairs

Regulatory affairs
Market Access
Portfolio Management

© 2013 Farmavita Regulanet Ltd.

Member of regulanet®

3
International Human Capital

JV Partners
Germany; England,
Croatia; Portugal;
FarmavitaR+
30+ staff and associates

regulanet ®
250+ staff and associates

FarmavitaR+ RA Community
(www.farmavitar.com)
1000+ registered users worldwide
© 2013 Farmavita Regulanet Ltd.

FarmavitaR+ covering 15 countries
EU – Czech, Slovakia, Hungary, Slovenia,
Croatia, Bulgaria. Romania
Non-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®

4
In-house vs. out-sourced
In-house

Outsourced

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

Sometimes

Yes

Overall costs linked only to performance

No

Yes

Easy scale-up/scale-down of operations

No

Yes

Simple monitoring of performance

© 2013 Farmavita Regulanet Ltd.

Member of regulanet®

5
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

© 2013 Farmavita Regulanet Ltd.

Member of regulanet®

7

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Network Managment of Pharmaceutical Development, Regualtory Affairs and Market Access

  • 1. International Regulatory Affairs and Market Access Your local guide for complex international journeys © 2013 Farmavita Regulanet Ltd. Member of regulanet® 1
  • 2. Scope of services © 2013 Farmavita Regulanet Ltd. Member of regulanet® 2
  • 3. Services Over Supply Chain Drug discovery Preclinical development Clinical trial phase Drug approval Marketing Project management Pharmaceutical development Preclinical development Clinical development Pharmacovigilance Strategic Regulatory affairs Regulatory affairs Market Access Portfolio Management © 2013 Farmavita Regulanet Ltd. Member of regulanet® 3
  • 4. International Human Capital JV Partners Germany; England, Croatia; Portugal; FarmavitaR+ 30+ staff and associates regulanet ® 250+ staff and associates FarmavitaR+ RA Community (www.farmavitar.com) 1000+ registered users worldwide © 2013 Farmavita Regulanet Ltd. FarmavitaR+ covering 15 countries EU – Czech, Slovakia, Hungary, Slovenia, Croatia, Bulgaria. Romania Non-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® 4
  • 5. In-house vs. out-sourced In-house Outsourced 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 Sometimes Yes Overall costs linked only to performance No Yes Easy scale-up/scale-down of operations No Yes Simple monitoring of performance © 2013 Farmavita Regulanet Ltd. Member of regulanet® 5
  • 6. 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 © 2013 Farmavita Regulanet Ltd. Member of regulanet® 7