CoPexis S.A.
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Mission and Services:
Copexis: Cum Apexis (Together To The Top)
MISSION

COPEXIS S.A. is a Switzerland-based quality-driven consultancy firm with expertise in:
Drug and devices development
Drug and devices regulatory services (CH/EU/US)
Medical writing
Pharmacovigilance and Safety Services
Manufacturing QA/QC/QP
Business development (EU/US)
Corporate development and management
The size and structure of COPEXIS consisting of PhD and MD experts allows us to provide our services with great flexibility at an attractive cost/benefit ratio. The combination of transparency and responsiveness creates the perfect operational and business conditions for our clients.

What sets us apart
Our company was born out of the desire to provide companies with access to the best possible advice and solutions.
Our expertise is based on numerous years of experience of working in the public and private sectors. Our activities are in line with EMA, FDA and other countries' regulatory requirements.
With our a long-standing experience in business aspects of biotechs and medtechs companies will also benefit from a large network of business partners and financiers.
We are responsive to the needs of our clients and take great effort to adapt ourselves around the client's processes. Whether integrated into a full-service or as a consultancy in one particular process improvement, we are able to offer a flexible delivery model according to customer needs.

Our domains of competencies:

Drug and devices development
COPEXIS' expertise covers all stages of drug and devices development including manufacturing, early and advanced preclinical pharmacology, de-risking and regulatory toxicology, clinical trials, regulatory on both side of the Atlantic. Globally, Copexis PhD and MD experts have been strategically involved in the development of over 30 drugs.
COPEXIS is specialized in providing these services for preclinical research, clinical research, marketed biopharmaceuticals/medical devices and other medical products.

Regulatory (EU/CH/US)
COPEXIS' hands-on expertise in strategic and operational regulatory affairs spans over the full range of regulatory services: document preparation, strategic advice, discussions/negotiations with regulatory authorities on both sides of the Atlantic and this for early as well as late stage programs.

Medical writing
With its MDs and PhDs, COPEXIS provide medical writing services in English and French. We help our clients to release high quality compliant documentation in an efficient and timely manner. Our medical writers have expertise and experience in writing of medical research documentation, regulatory submission documentation and promotional/sales material.

Pharmacovigilance and Safety Services
COPEXIS offers safety services for the pharmaceutical, medical device, chemical, agrochemical, and other related industries.
We help our clients to design and implement their toxicology and safety programs as well as to collect, assess and report safety information for their programs.

Manufacturing QA/QC/QP
Some of COPEXIS experts are experienced in manufacturing QA/QC or have acted as QP in relation to national, EMA and FDA requirements. Copexis can hence offer these services mainly for European-based companies.

Business development
COPEXIS offers safety services for the pharmaceutical, medical device, chemical, agrochemical, and other related industries.
We help our clients to design and implement their toxicology and safety programs as well as to collect, assess and report safety information for their programs.

Corporate development and management
COPEXIS offers safety services for the pharmaceutical, medical device, chemical, agrochemical, and other related industries.
We help our clients to design and implement their toxicology and safety programs as well as to collect, assess and report safety information for their programs.


TRACK RECORD

- drug development (24 drugs) from lead to clinics to registration (EMEA/FDA), with drugs on the
market worldwide
- set-up, management and development of three parmaceutical companies on both sides of the Atlantic
- one of the largest European Series A financing in 2005, exit in 2007 with multiples

CoPexis S.A.
3 Tourronde
CH-1009 Pully/Lausanne
Switzerland
tel: +41 79 771 271 9
fax: +41 21 691 50 31
info@copexis.com