CENEXI SERVICES

The Cenexi Services team, with exceptional regulatory, formulation and analytical expertise, will manage your entire project from preformulation and formulation, to pilot scale and commercial production – for all dosage forms. All of our facilities have been successfully inspected by all major global regulatory authorities, enabling us to serve customers worldwide. Cenexi is also registered in 124 countries and has developed a strong reputation for the expert handling of complex product portfolios. All of our facilities meet the highest current expectations (EMEA, FDA, PMDA, ANVISA and others). Cenexi Services is also approved by the French Ministry of Research and Technology for the Research Tax Credit (CIR).

FORMULATION

Cenexi Service’s experts can help you process all your 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 including cytotoxics
• 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

Cenexi Services also offers a wide selection and comparison of primary and secondary packaging.

ANALYTICAL DEVELOPMENT

Our teams of analytical experts offer extensive services that include the following:

• Study of active ingredients
• Development 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 dedicated facilities, Cenexi Services can manufacture batches from preformulation to clinical trials; for high-potency products, as well as biological or traditional dosage forms. We cover the following:

• Sterile solutions
• Suspensions
• Emulsions
• Solid forms
• Lyophilized forms
• Semi-solid forms

Cenexi Services also performs filling in a broad range of primary packaging including:

• Bottles – glass and PE
• Syringes
• Ampoules
• Single-use
• Blister packs

CLINICAL BATCHES

Cenexi Services can manufacture your drug products for clinical trials:

• Solid forms including hormones (1kg batches, minimum)
• Sterile liquid forms including cytotoxic (1L batches, minimum)
• Lyophilized forms
• Semi-solid forms

TECHNICAL TRANSFER AND VALIDATION

• Cenexi Services will assemble a multidisciplinary transfer team, under the direction of your dedicated project manager who also serves as your main contact
• Upon receipt of your documentation, a GAP analysis is created, to discuss and validate the proposed transfer strategy and planning with you
• 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 file writing and other filing is completed to your expectations
• The project manager will also create a comprehensive project report for your records

STABILITY TESTING

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:

• 5°C
• 25°C/60% RH
• 30°C/65% RH
• 30°C/75% RH
• 40°C/75% RH
• Photostability

REGULATORY SUPPORT

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, and we have file-writing expertise that spans 124 countries worldwide.

All three Cenexi facilities have been successfully inspected by the important regulatory bodies:

• Fontenay-sous-Bois (Headquarters) in Paris, France has been successfully inspected by ANSM (EU), ANVISA (Brazil), PMDA (Japan), FDA (USA), KFDA (Korea).
• Osny in Paris, France has been successfully inspected by ANSM (EU), ANVISA (Brazil), FDA (USA), KFDA (Korea).
• Cenexi-Laboratoires Thissen, located in Braine-l’Alleud in Belgium has been successfully inspected by AFMPS (EU), ANVISA (Brazil), PMDA (Japan), FDA (USA).

Cenexi has been successfully inspected by the ANSM, FDA, ANVISA, PMDA, and other similar bodies. We are registered with the public health authorities in all the countries we work with, facilitating registration of our sites for new production operations. Cenexi is registered in more than 124 countries worldwide:

PRODUCT LIFE CYCLE MANAGEMENT

Our experts are able to advise on product improvement and enhancement strategies, in areas such as:

• Analytics
• Formulation
• Process
• Packaging
• Regulatory
• Brand extension development