Pharma expertise

Our Global Pharma Customer Technical Service (CTS) will partner with you on pharmaceutical developments. Our CTS team brings expertise in powder technology and preparation, direct compression, tablet evaluation, formulation of pharmaceutical confectionery and pharmaceutical syrups.

Roquette Global Pharma Customer Technical Service (CTS)

Powder technology

  • Extensive knowledge of powder properties, essential to efficient table production.
  • Expertise in areas such as bulk density, compressibility, hygroscopicity, particle size, flow ability and dust formation.

Powder preparation

  • Powder preparation for compression or filling of sachets or hard capsules.
  • Skilled operations such as mixing, coloring, flavoring, and wet or dry granulation, critical to ensure high quality products delivery.

Direct compression

  • Customized solutions for formulation development including manufacturing settings prediction for industrial equipment addressing compression simulation issues. (Compression Simulation Service.)
  • Direct compression: cost-effective solutions to optimize formulations and processes.

Tablet evaluation

  • Quality control testing of tablets.
  • Monitoring of hardness, thickness, weight, density, friability, and disintegration and dissolution times.
  • Application of additional methodologies to better understand tablet features such as appearance observation using electron microscopy or instron measurements.

Pharmaceutical syrups

  • Parameter control for active ingredients, including pH, color stability, precipitation, suspension and separation, crystallization and cap-locking.

Pharmaceutical confectionery

  • 30 years of experience in sugar-free confectionery with expertise that is easily applicable to pharmaceutical formulations.

Formulation expertise

  • Intimate partnership with customers under confidentiality agreements, having developed as many as 100 formulations a year. 
  • Expertise tailored to every step of manufacturing process, across a wide range of applications.

On-site assistance

  • Trial assistance
  • Process parameters optimization

Roquette Pharma CTS can assist with your developments, with expertise in powder technology and preparation, direct compression, tablet evaluation, formulation of pharmaceutical confectionery and pharmaceutical syrups. Contact us to find out how we can help you!

labo pharma

 

Other fields of expertise

Roquette quality and engagement

Quality management is a top priority for Roquette backed by our established and ambitious global quality policy according to these key values:

  • Customer satisfaction.
  • Continuous improvement of reliability, capacity and efficiency of our processes, our products and our services.
  • Conforming all activities in a lawful manner and obeying legal regulations which extends to our commitment to customers.
  • Compliance of production practices for pharmaceutical excipients with worldwide best practices.
  • Integrated Quality Management System (QMS), regularly re-evaluated by recognized authorities, ensuring that our products comply with all appropriate standards.
  • Roquette’s manufacturing plants are regularly audited by international regulatory bodies (US FDA) and the European authorities (French ANSM).
  • Plants that manufacture pharmaceutical products, notably actives, operate by GMP standards (European ICHQ7A and US 21CFR).
  • Central Quality Control Laboratory in Lestrem has been awarded the COFRAC accreditation for analysis in raw materials. Analytical certificates are issued with compliance to the principal pharmacopoeia monographs: EP, USP and/or JP, IP.
  • Professional in-house audit teams provides inclusive service for all pharmaceutical ingredients ensuring regulatory compliance.
  • Roquette’s European plants ensure full traceability and guarantee the use of conventional corn (maize), externally audited and approved by BUREAU VERITAS.
  • Roquette obtained the EXCiPACT™ certification on December 2015. SGS, one of the international auditors authorized to grant approval under this standard, audited and recommended ROQUETTE’s site based in Lestrem, France, to be EXCiPACT™ certified. EXCiPACT™ certification ensures top-level quality throughout the entire supply chain, and gives the customers access to the full documentation mandated by regulators.

 

Regulatory support 


The pharmaceutical industry is heavily regulated, with incredibly stringent rules.

The preparation of product files for market approval is an essential and time-consuming step in the final product development process. All formulation ingredients must be described and compiled where process information and analytical data might be needed.

Our in-house Regulatory Department has many years of experience in managing these processes around the world. In addition, Roquette products have obtained required regulatory status in many different applications worldwide.

Roquette is actively involved in various international trade associations such as IPEC and quality decision groups within the Pharmacopoeias.

This well-rounded information and experience accumulated is invaluable. Roquette makes this information available to help you simplify and speed up your own product filings.

Please feel free to contact us or your local Roquette representative for further information.

Customer Engineering Service 

The handling of industrial quantities of powder or liquid products often represents an engineering challenge, especially when the products are ingredients or raw materials for the preparation of high-quality pharmaceuticals.

Roquette has an established Engineering Customer Service with exceptional worldwide experience in the design and construction of the reception tanks, vessels and powder-handling facilities best suited for Roquette products.

This Service is available year-round to offer proven solutions to the industrial-scale handling of our products.

Please feel free to contact us or your local Roquette representative for further information.
Get in touch to discuss your needs
Your success is our greatest priority, and your needs are unique. We would love to better understand your needs and connect you with our experts.
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