Cenexi Services is a pole of expertise supporting formulation activities, analytical and pharmaceutical form developments, industrial transfer, and regulatory support.
A service upstream and downstream of the manufacturing process
In addition to industrial-scale drug manufacturing and packaging, Cenexi offers its customers regulatory and logistics services upstream of manufacturing and during drug development stages as well as downstream regardless of whether the innovative products to be manufactured on Cenexi sites are experimental or already on the market.
These services are provided by Cenexi Services, the independent entity which employs 120 experts supporting formulation activities, analytical and pharmaceutical form developments, industrial transfer, and regulatory support.
Cenexi Services teams thus provide extensive analytical and regulatory expertise as well as cutting edge formulation skills. They are able to run projects from end-to-end, from preformulation and formulation, to commercial production, for all pharmaceutical forms.
Cenexi Service’s experts can help to process all the preformulation and formulation needs. They will design all the necessary steps to validate the manufacturing process, API quality and choice of excipients.
Our team conducts the formulation work that includes the following specialties:
- Sterile vials, liquid or freeze-dried, including cytotoxics
- Prefilled syringes including cytotoxics
- Aseptic and sterilized injectable ampoules
- Tablets and capsules, including hormones, uncoated, film-coated, sugar-coated, sustained-release, double core, gastro-resistant
- Syrups, creams and lotions
Cenexi Services also offers a wide selection and comparison of primary and secondary packaging that can be compared to choose the best one.
Our teams of analytical experts offer extensive services that include the following:
- Study of active ingredients
- Development, optimization, transfer, check and validation of analytical methods for drug products, raw materials and cleaning methods
- Development and validation of dissolution profiles
- Development and update of analytical methods for degradation products (ICH Q3B)
Process development and optimization
With its dedicated facilities, Cenexi Services can manufacture batches for all development stages from preformulation to clinical trials. These products range from highly active drugs to traditional pharmaceutical forms.
Cenexi Services covers the following formulations :
- Sterile solutions
- Sterile suspensions
- Sterile emulsions
- Solid forms (tablets and capsules)
- Sterile lyophilized forms
- Syrups, creams and lotions
Cenexi Services can also perform the filling of a broad range of primary packaging, including :
- Bottles, in glass and PE
- Blister packs
Cenexi Services can manufacture drug products for clinical trials:
- Solid forms including hormones (1kg batches, minimum)
- Sterile liquid forms including cytotoxic (1L batches, minimum)
- Lyophilized forms
Technical transfer and validation
Cenexi Services sets up a multidisciplinary transfer team led by a project manager assigned to its clients:
- Upon receipt of the client’s documents, we establish a GAP analysis to discuss the proposed transfer strategy and planning with him
- Our process and analytical experts will critically review the strategy and identify any possible process and methodology enhancements
- The validation and stability studies are executed as expeditiously as possible
- Variation files and other administrative procedures are written or reviewed according to expectations
Cenexi Services is able to design, execute and analyze pre-stability, regulatory or commercial stability studies, according to the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) conditions:
- – 20°C
- 5 °C
- 25 °C/60 % RH
- 30 °C/65 % RH
- 30 °C/75 % RH
- 40 °C/75 % RH
Cenexi is renowned for its strong regulatory expertise and can provide expert counsel regarding any aspect of your regulatory strategy.
Our regulatory experts will create your market authorization files (CTD module 3) and variation files. We have a broad knowledge of the requirements for marketing authorization applications in 124 different countries, as we are registered with the public health authorities of these countries for which we manufacture drugs. This of course facilitates the registration of our sites for new manufacturing transfers.
Finally, all of our Cenexi sites have been successfully inspected by the major regulatory bodies:
- ANSM (France)
- AFMPS (Belgium)
- ANVISA (Brazil)
- FDA (United States)
- KFDA (South Korea)
- PMDA (Japan)
Discover below the countries where Cenexi is registered:
Central African Republic
St. Vincent & Grenadines
Trinidad & Tobago
United Arab Emirates
Hong Kong SAR China
Bosnia & Herzegovina
Product life cycle management
Our experts are able to advise on product improvement and enhancement strategies, in areas such as:
- Brand extension development