Integrated Drug Development Consulting ServicesDetails
COPEXIS S.A. offers integrated drug development consulting services and strategic planning for the pharmaceutical industry.
With a focus on speed and effectiveness supported by more than 30 years of experience across a wide range of pharmaceutical molecules, Copexis is the ideal partner to design, implement and manage drug developments that meets the current regulatory standards and supports clients through the production, toxicology, clinical and regulatory processes for fast and efficient achievements.
Drug Development Consulting Services
Copexis provides integrated consulting services for drug companies with a focus on product development, manufacturing, safety & toxicology, clinical programs, regulatory compliance and registration.
Based in Switzerland, Copexis has extensive worldwide experience in the drug development sector supporting more than 40 developments including proteins / antibodies, peptides, small molecules and cell therapy.
The consultancy firm has a core focus on early and middle stages of drug development and offers comprehensive support from the drug candidate development up to and including clinical Phase II studies. Copexis also has deep knowledge and experience in supporting late stage programs, including Phase III clinical studies and registration.
You can rely on Copexis to support your drug development project in an integrated manner through every stage of the product’s lifecycle, from laboratory to market.
Consulting & Implementation of Drug Development Programs
As well as providing reliable advice and strategic planning services, Copexis also supports “hands-on” implementation and oversight of the manufacturing, toxicology, clinical and regulatory programs.
The company’s experience in pharmaceutical product development processes spans across clinical studies (Phases I-III), toxicology programs, safety and tolerability, pharmacokinetics, formulation, Good Manufacturing Practices (GMP), statistical assignments, and project management.
Copexis works on drug development programs with types of assets including:
- Proteins / antibodies (recombinant and biologics)
- Peptides (including half-life extensions, slow-release formulations and dextrogyre)
- Small molecules
- Cell therapy
- Orphan drugs and expedited review processes
Copexis is especially distinguished in therapeutic areas including immunology, central and peripheral nervous system diseases including pain, endocrinology, oncology, ophthalmology and nephrology.
Drug Regulatory Affairs Consulting Services
Regulatory affairs (RA) play a critical role in the pharmaceutical industry. Copexis can manage all regulatory aspects of your drug development program in Europe and Switzerland.
The regulatory affairs solutions for drug development offered by Copexis are smart, professional, and individually created for each customer’s registration and authorisation projects.
With a clear and up-to-date understanding of regulatory requirements, Copexis is a reliable RA partner to advise on relevant directives, laws and guidelines, as well as draw on its experience of working with the relevant authorities.
Corporate Development and Management for Pharma Companies
Copexis provides corporate development and management services dedicated to maximizing the potential for the success of your drug product.
By combining development and commercial insights, and ensuring the existence of cost-effective development strategies, Copexis can help your company to swiftly achieve its clinical development goals, market approvals, high sales volumes and profitability.
Copexis understands how to leverage your particular company strengths to increase market share and influence in the highly competitive pharma industry.
About COPEXIS S.A.
COPEXIS S.A. is a Switzerland headquartered consultancy firm serving the biotech and pharmaceutical industries with experience spanning over more than 30 years and over 40 drugs developments.
The consultancy has a track record which includes the development support of marketed therapeutic drugs with annual sales of up to 1 Billion Euros and medicines licensed or optioned for up to 1,2 Billion Euros.ServicesDownloadsImproving half-life and cell penetration in a peptide identified to efficiently interact with a newly discovered intracellular pathway. A Copexis …
Read MoreThe evolution towards a lipidated peptide can markedly reduce doses required to achieve the same efficacy. A Copexis Case Study …
Read MoreFully Integrated Drug Development Consulting: CMC, Clinical, Toxicology and Regulatory Support A Copexis Case Study Virtual Integrated Development: a paradigm …
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