Quality, Regulatory and Formulation Support

Partnering on Innovation, Quality, and Technical Excellence 

We believe true innovation happens when formulation science and compliance expertise work hand in hand. That’s why our dedicated teams, spanning regulatory support, Customer Technical Services (CTS), and quality management collaborate closely with customers to help them overcome the most complex challenges in drug delivery and manufacturing. 

Regulatory Support 

Navigating the complex regulatory landscape is critical for pharmaceutical and biopharmaceutical success. Roquette’s in-house regulatory support team helps streamline product filing by organizing product files, accurately describing ingredients, compiling analytical data, and ensuring compliance with global pharmacopeial standards. Leveraging long-standing relationships with IPEC (International Pharmaceutical Excipients Council) and quality decision groups within international pharmacopoeias, we provide formulators with the guidance and confidence needed to bring safe, compliant products to market efficiently. 

Customer Technical Services 

Our Customer Technical Services (CTS) team delivers comprehensive support for pharmaceutical formulation development. CTS assists with powder technology, covering density, compressibility, hygroscopicity, particle size, flowability, and powder rheology. Our labs are equipped to provide guidance on powder blending, including mixing, wet and dry granulation, and taste masking. CTS supports oral solid dosage form development, offering formulation services, optimization, and troubleshooting using compaction simulators, and a full suite of equipment for tablets, hard shell capsules, softgels, and powder formulations. The CTS team stays current with pharmaceutical trends and can assist with digital modeling, suggestions for continuous manufacturing, and bioavailability enhancement of poorly soluble drugs.  

CTS also offers analytical testing to support drug product development and investigation. Each analytical lab is equipped with dissolution testing, chromatography, various water determination methods, solid state characterization, microscopy, particle size determination, among other tests. Please contact us to inquire about our full range of capabilities and instruments. Small scale packaging is offered as well to support stability testing. Each lab is equipped with stability chambers to support ICH stability studies.  

Roquette’s Quality Promise 

At Roquette, quality is central to everything we do. Our integrated Quality Management System (QMS) ensures full compliance with international standards and continuous improvement across our supply chain. Regular external audits, GMP, COFRAC (French Committee for Accreditation), EXCiPACT™ certifications, and additional quality accreditations guarantee reliability and traceability of every product. From raw materials to final formulations, Roquette delivers confidence that all ingredients meet the stringent quality expectations of global pharmaceutical and biopharma markets. 

Get in touch to learn more about our services and expertise!