Our History
Cevidra is an independent and family-owned pharmaceutical company belonging to Destaing Participation Group.
2021: Implementation of manufacturing activities (New service offer: secondary packaging/batch release)
2015: Wholesale Export Distributor and importer (Opening to new markets)
2012: Product storage capacities extension (Settled in an Excellence Center for Health & Science)
2007: Pharmaceutical Exploitant authorized by the ANSM (Creation of Cevidra)
CPCO – Contract Pharmaceutical Commercial Organization
Cevidra is your GMP/GDP pharmaceutical structure offering the organisation, the ressources and the expertise to access to the French Market covering Early Access (EAPs), Compassionate Access (AAC) & Licensed (MA) products.
With the French pharmaceutical Exploitant status, Cevidra is considered as a Contract Pharmaceutical Commercial Organization (CPCO). We acts as a French local subsidiary for small & mid-size companies to support the launch, storage, distribution, sales, and market access of their medicinal products.
Our added value
Cevidra is a GMP/GDP compliant company providing tailored-made services & a one-stop solution to bring medicines to the French market.
Our strength lies in the agility and reactivity of our dedicated project manager (Senior Pharm.D.) and the provision of our well-established professional network to help you on the road to success.
What we do as a subsidary
Our extensive experience serving pharmaceutical firms in all therapeutic areas has given us a deep knowledge of global commercial trends affecting the industry, including reimbursement issues.
Helping clients maximise the commercial value of their medicines by supporting them in:
Early access programs management
Compassionate use importation
Market access
Promotion & sales
Post-market surveillance
Supply chain optimization
Cevidra’s status
Exploitant status
But what is an Exploitant?
In France, a medicine’s access to the market requires that the holder of the market authorisation (MA) or the holder an Early Access Products (EAPs, ex-ATU) also be an “exploitant” or have entered into a contract with an “exploitant”. The “exploitant” is a pharmaceutical company whose activities are governed by an Opening Authorisation and a GDP (Good Distribution Practices) certificate and that is regularly inspected by the ANSM. This status is specific to France.
Article R5124-2 of the Public Health Code
“3° Exploitant, the company or organisation providing the exploitation of medicinal products other than the experimental medicine, generators, kits, precursors mentioned in paragraph 3 of article L. 4211-1.
Exploitation comprises the wholesale or the free transfer of advertising, of information, of pharmacovigilance, of batch tracing and, where applicable, of their withdrawal, as well as the related storage operations, if any.
The operation is carried out either by the holder of the marketing authorisation mentioned in article L. 5121-8, of the temporary use authorisation mentioned in paragraph a of article L. 5121-12 or of one of the registrations mentioned in articles L. 5121-13 and L. 5121-14-1, by another company or another organisation acting on behalf of the holder, or by both the holder and the other organisation, each carrying out in this case one or more categories of operations constituting the operation of the medicinal product or product.”
Article R5124-2 of the Public Health Code
5° Wholesaler-distributor, any enterprise engaged in the purchase and storage of medicinal products other than those intended to be tested on humans, with a view to their wholesale distribution in the state;
Wholesaler-Distributor status
The wholesale distribution of medicines for human use and other products covered by the pharmaceutical monopoly, as well as the distribution of experimental medicines, can only be carried out by GDP pharmaceutical establishments.
The opening of a pharmaceutical establishment is subject to an authorization issued by the ANSM, after obtaining the opinion of the Central Council of the National Order of Pharmacists.
Importer status
An importer is a pharmaceutical company whose activities are governed by an Opening Authorisation and a GMP (Good Manufacturing Practices) certificate.
Its activities may be limited to the physical storage of the imported products or also include the control/ release of the imported batches.
Article R5124-2 of the Public Health Code
“2° Importer, the company or organisation importing, storing, quality control or the liberation of batches, for the purpose of their wholesale, their free transfer or their testing on humans, of medicine, products or objects listed under article L. 4211-1 and paragraph 4° of article L. 5121-1L. 5121-1 originating from.
a) State that are not members of the European Community, nor parties to the agreement on the European Economic Area
b) Or other Members states of the European Community or parties to the agreement on the European Economic Area when the medicine, products or objects were manufactured by an institution that is not authorised pursuant to article 40 of Directive 2001/83 dated 6 November 2001 on the Community code relating to medicinal products for human use.”
Our values
These are the core values that drive our team and improve the trust of patients, families and pharmacists every day.
Over time, we build trust with our partners and establish a strong partnership that allows us to act as a subsidiary of the company.
Our Commitment
As a pharmaceutical establishment, Cevidra is a committed and trusted partner. We provide tailor-made services to develop long term partnerships with our clients and all our activities are conducted in accordance with GDP & GMP standards. Our authorizations are periodically renewed by the French Health Authority (ANSM).