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Corporate Profile

March 2018
PharmLex2014/Rasan/Intro slide 1
Pharmillennium Consulting d.o.o., limited liability company for
consulting, services and trade was established in Herceg Novi,
Montenegro, June 2000.
Scope of business:
Providing services to customers - manufacturers, MA/License holders,
wholesalers, agent companies, QC laboratories, medical institutions and
regulatory bodies in the scope of pharmaceuticals, medical devices, food
supplements and cosmetics.
Areas of services include (but not limited to) – quality systems and standards
(GMP, GDP, ISO, etc.) implementation and auditing, registration/licensing
documentation development, compilation and management (paper and
electronic), business development expertise, market research and RA
strategic studies, RA services and submissions, MA/License holding services
including QPPV and vigilance services, Batch Release and Testing services in
EU, QP services, turn-key manufacturing sites engineering, design and
management, pharmaceutical and technology development, contract
manufacturing support, etc.

PHMC Company Profile, March 2018


slide 2
Pharmillennium Consulting d.o.o., has developed
corporate structure and network enabling provision of
services worldwide.
PHMC Ltd. Cyprus manages EU and RoW projects

• EU:
Croatia, Slovenia, Bulgaria, Czech, Slovakia, Malta, Hungary, Romania,
Lithuania, Greece, UK, Portugal, Italy, Germany, Switzerland, etc.

• WBC (West Balkan Countries) - affiliates and local partners (Pharma


Concept d.o.o., Win Pharm d.o.o., Multi d.o.o., Multi BG d.o.o.)
Montenegro, Serbia, Bosnia and Herzegovina, Kosovo, Albania,
Macedonia

• RoW:
China, India, Iraq, Iran, Emirates, South Africa, Turkey, Russia, South
Korea, etc.

PHMC Company Profile, March 2018


slide 3
Recognizing the enlarged needs for knowledge and
development, for the last few years we are developing our
offer for dedicated, turn-key services to our customers.

By our expertise, practical experience and knowledge, as well as in close


cooperation with specialized companies and recognized international experts
in the same scope, we are able to provide a wide scope of services and
knowledge,
Staying up to date with constant development of applicable international
and national standards and regulations is demanding challenge, but also a
must for all of us, dealing with pharmaceuticals, medical devices, food
supplements and cosmetics.

Strict regulations for every ‘’life cycle’’ stage of one medicine, medical device, food
suplement or cosmetic product are forcing all stakeholders involved, to constantly
improve themselves, in order to achieve and mantain the most important
requirements for each pharmaceutical product:
Quality, safety and efficacy !

PHMC Company Profile, March 2018


slide 4
Head experts and management:

◊ Mr. Pharm. QP/QC Spec. Dragana Boberić Borojević


◊ Business Development Director
◊ Former Head of Registrations Committee at the Institute of
Pharmacy/Head of NCL Instrumental Laboratory - Agency for Medicines
and Medical Devices of the Republic of Serbia
◊ Former Assistant Minister of Health of the Republic of Montenegro, Head
of Pharmaceutical Sector

◊ Mr. Pharm. Predrag Ristić


◊ CEO
◊ Former Deputy General Manager at the Institute of Pharmacy -
Agency for Medicines and Medical Devices of the Republic of Serbia,
Head of National Quality Control Laboratory
◊ Former Adviser to the Minister of Health and Minister of Agriculture of
the Republic of Montenegro

PHMC Company Profile, March 2018


slide 5
Areas of services offered:
1. Regulatory support in the health 8. Laboratory engineering, design and
care and pharmaceutical sector contract analytical methods
2. QA, GMP & Validation, GLP, GCP, development
GDP & GPP and ISO standards 9. Medical institutions (clinics,
implementation, auditing, and ordinations) full support – designing,
certifications organisation, HR support
3. QP services, Batch Release,
BatchTesting in EU 10. Engineering, design, turn-key solutions
4. Computerized Information Systems and contract cooperation
in medicine and pharmaceuticals development of manufacturing sites
for pharmaceuticals, supplements and
5. Development of documentations for
MDs
registration and licensing of
medicinal products (chemical, 11. Legal advising and corporate
biological and biotechnology) and legal/administrative consulting
medical devices in EU services
6. RA services - registration/notification
12. Business development and Marketing
of medicines, medical devices,
consulting services
supplements and cosmetics
7. Scientific translating and editing
services
PHMC Company Profile, March 2018
slide 6
Reference List of Clients
1. Ministry of Health, Serbia 22. Jewim Pharmaceuticals, China
2. Ministry of Health, Montenegro 23. DPBR SA, Switzerland
3. Ministry of Agriculture, Montenegro 24. WellPharma, Abu Dhabi
25. Rasan Pharmaceuticals, Iraq
4. Glaxo Ware, UK
26. D.Med Group, Germany
5. Torlak, OPV Vaccine mfg. site, Serbia
27. Medical Intertrade, Croatia
6. Hemofarm, Stada, Serbia 28. ASA Group, Bosnia
7. Zdravlje Actavis, Serbia 29. Prevent Group, Germany
8. Actavis Trading, Malta 30. Avicenna Pharma, Turkey
9. InterEvrogenex, Macedonia 31. CSBIO, China
10. PharmaS, Croatia 32. Panacea Biotech, India
11. Alvogen Balkans, Luxembourg 33. BC PharmaTech, Cyprus
12. Alvogen Pharma, Serbia 34. Cardinal Health and Cordis,
13. Esensa Pharma, Serbia Switzerland, USA
35. GryNumberHealth, Lithuania
14. Laboratorios Basi, Portugal
36. UAB Alfa Linija, Lithuania
15. TMC Pharma Services, UK
37. Semperit, Austria
16. Salix Pharmaceuticals, USA 38. PharmDedict, Bulgary
17. Bosnalijek, Bosnia 39. Yaklasim Mak.San. ve Ticaret, Turkey
18. Clinres Nova, Croatia 40. Palmolive/Colgate, Italy
19. ELC Group, Czech 41. PharmaKos, Croatia
20. CIPLA Ltd, India 42. World Medicine, Turkey
21. Newlystar Medtech, China 43. Unimed Pharm, South Korea

PHMC Company Profile, March 2018


slide 7
Pharmillennium Consulting corporate
network and our partners have team of
experts covering broad range of We really believe that we could offer
specialized knowledge which is necessary you as much as you need and satisfy
in order to provide customers high level of you as much as possible.
professional and scientific services in all
the areas concerned:
◊ recognized specialists in GMP, We wish you to enter the new era of
◊ pharmacology, clinical pharmacy, development and success with
◊ toxicology, medicines control, PHARMILLENNIUM CONSULTING
and our partners.
◊ microbiology and virology,
◊ pharmaceutical technology
◊ laboratory quality control, batch March 2018
release,
◊ experts for the scopes of information
and IT services, legal sciences, economy,
construction works, etc.

PHMC Company Profile, March 2018 slide 8