Regulatory Sciences
We’re proud to say we are the World’s Leading Regulatory Consultancy, with decades of experience across all drug types (small molecule, biologics, oligonucleotides, and combination products) and medical device classes.
We offer flexible solutions tailored to meet your needs, with options ranging from project-based services, where our consultants work as an integrated part of your team, spanning to a fully outsourced mode, where we will take care of all of your regulatory activities
Quality & Compliance
Our full suite of Quality and Compliance (Q&C) services helps clients across the EEA with customized solutions to fit their specific needs. Our team of highly skilled Qualified Persons (QPs), Responsible Persons (RPs), and Quality Assurance (QA) officers have helped many clients obtain and maintain their WDA/MIA licenses. We also hold our own MIA license in both the UK and EU, if you would like to outsource your batch certification entirely, and offer global auditing services with over 350 vetted auditors worldwide.
Pharmacovigilance
Our full suite of customizable Pharmacovigilance (PV) services can provide you with expertise in set-up and maintenance of global and local PV systems, including Qualified Person responsible for Pharmacovigilance (QPPV) & local QPPV (LPPV) services, ICSR management, aggregate report writing, Pharmacovigilance System Master File (PSMF) and Risk Management Plan (RMP) development and maintenance, literature screenings, signal management and regulatory intelligence. Our team of qualified experts, combined with integrated technology, ensure your product meets the highest levels of compliance with both regional and global regulations.
Contact Center Support
With our scalable and 24/7 availability contact centers, we offer multilingual support from native-speaking medical professionals, so we can respond to product inquiries in a swift manner that is consistent with product labeling and regulatory guidance, but also with local evidence, culture, and communication styles.
In Europe, our experts offer support in English, French, German, Italian, Spanish, Dutch, Czech, Danish, Finnish, Greek, Hungarian, Norwegian, Polish, Portuguese, Romanian, Russian, Slovakian, Swedish, Arabic, and Turkish.
We also offer solutions to support patients, caregivers, and healthcare professionals to initiate and sustain therapies, helping them to overcome barriers and achieve better health outcomes.
Global Footprint
Europe
United Kingdom
North America
Asia-Pacific
Sarajevo
Alipašina 29, 71000 Sarajevo, Bosnia and Herzegovina
Podgorica
Bul. Svetoga Petra Cetinjskog 114/I, 81000 Podgorica, Crna Gora
Skopje (Office)
st. Fjodor Dostoevski no. 72 (Industrila zone Karpos area Vlae), Skopje
Brasov
Saturn Boulevard no. 42/A 3rd floor, Ap. 13, 500164 Brasov, Romania
Sofia
M3 Business Center 17 Filip Avramov Street Fl.2, Office 307, 1712 Sofia, Bulgaria
Tbilisi
Shartava Street, # 40, Tbilisi, Georgia
Tirana
Rruga Xhanfize Keko Nr. 56, Njesia Administrative 12, H 2, Z. 505, Tirana, Albania.
Global Footprint
Europe
Berlin
Siemensdamm 62
13627 Berlin
Leiden
Schipholweg 59
2316 ZL Leiden
Lund
Medicon Village
223 81 LUND
Stockholm
Fleminggatan 18
SE -112 26 Stockholm
Zagreb
Ulica grada Vukovara 269a, 10000 Zagreb, Croatia
Sarajevo
Alipašina 29, 71000 Sarajevo, Bosnia and Herzegovina
Belgrade
Beogradskog bataljona 4, 11000 Belgrade, Serbia
Podgorica
Bul. Svetoga Petra Cetinjskog 114/I, 81000 Podgorica, Crna Gora
Skopje
Ul. Arso Mickov 29, 1060 Skopje, Macedonia
Skopje (Office)
st. Fjodor Dostoevski no. 72 (Industrila zone Karpos area Vlae), Skopje
Brasov
Saturn Boulevard no. 42/A 3rd floor, Ap. 13, 500164 Brasov, Romania
Sofia
M3 Business Center 17 Filip Avramov Street Fl.2, Office 307, 1712 Sofia, Bulgaria
Tbilisi
Shartava Street, # 40, Tbilisi, Georgia
Tirana
Rruga Xhanfize Keko Nr. 56, Njesia Administrative 12, H 2, Z. 505, Tirana, Albania.
UK
Birmingham
Unit 2.03, ICENTRUM
Holt Street
Birmingham B7 4BP
London
John Stow House 18
Bevis Mark
London EC3A 7JB
North Yorkshire
Olliver, Aske, Richmond
North Yorkshire, DL10 5HX
US and Canada
Raleigh (HQ)
107 West Hargett St.
Raleigh, NC 27601
Bozeman
274 Discovery Dr, Suite 100 Bozeman, MT 59718
Chicago (Deerfield)
10 Parkway North, Suite 310
Deerfield, IL 60015
Chicago (Loop)
200 N. Lasalle Street, Suite 2450
Chicago, IL 60601
Philadelphia
501 W. Office Center Dr, Suite 350
Fort Washington, PA 19034
San Diego
10590 West Ocean Air Drive, Suite 220
San Diego, CA 92130
Washington, DC
1129 20th St NW, Suite 600
Washington, DC 20036
1-202-833-8077
Windsor
3000 Temple Dr, Suite 200
Windsor, ON N8W 5J6
1-519-252-9555
Asia-Pacific
Melbourne
Suite 6, Ground Level
452 Johnston Street
Abbotsford, VIC 3067
Hyderabad
3rd Block, 7th Floor,
My Home Hub, Madhapur, Patrika Nagar, HITEC City,
Hyderabad, Telangana 500081
Tokyo
5-27-5 Sendagaya, Shibuya-ku (suite 13-101, 13-102, 13-113, 13-130)
Makati City
7th Floor Office F
Armstrong Corporate Center
HV Dela Costa Ave.
Salcedo Village
Makati City
Shanghai
Room 04N162, 4/F, Annex No. 138 Huaihai Middle Road Huangpu District Shanghai
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