The pharmaceuticals sector is among the most heavily regulated in the world. From organizing product files, to accurately describing ingredients and compiling analytical data, preparing a medicinal solution for market is a complex and time-consuming operation for even the most established drug producers.
With years of experience managing these processes in markets around the world, our in-house regulatory department is here to help streamline your product filing process. Our deep-rooted relationships with various international trade associations, including IPEC and quality decision groups within the global Pharmacopoeias, means we can ensure full compliance of your products for complete peace of mind.
Could your regulatory process benefit from an expert partner?
Customer Engineering Service
Handling industrial quantities of powder or liquid can be quite the engineering challenge, especially when the ingredients are intended for use in high-quality pharmaceuticals.
Our long-established Customer Engineering Service offers drug manufacturers complete support for the design and construction of processing equipment, including reception tanks, vessels and powder-handling facilities.
Available worldwide and all year-round, we provide proven solutions to help you handle industrial-scale ingredients processing and get the best out of our premium product portfolio.
Let’s tackle your engineering challenges, together.
Our Customer Technical Service (CTS):
Supporting pharmaceutical formulation development
Powder technology and preparation, direct compression, tablet evaluation, pharmaceutical confectionery solutions, syrup formulation and much more: Our leading Customer Technical Service provides 360-degree support for your drug development projects. Our CTS covers:
Pharmaceutical powder technology
- Bulk density, compressibility, hygroscopicity, particle size, flowability and dust formation
Pharmaceutical powder preparation
- Mixing, coloring, flavoring, and wet or dry granulation
- Formulation advice, customized settings planning and calibration, tablet evaluation, Compression Simulation Service
Tablet quality control testing
- Assessing hardness, thickness, weight, density, friability, disintegration and dissolution time, appearance monitoring, observation using electron microscopy or Instron measurements
Parameter control for pharmaceutical syrups
- Assessing pH, color stability, precipitation, suspension and separation, crystallization and cap-locking
- Expert formulation support and on-site assistance
Quality above all else
At Roquette Pharma Solutions, quality is everything.
In all our processes, products and services, we are committed to customer satisfaction – continually searching for ways to improve reliability, capacity and efficiency.
Our integrated Quality Management System (QMS) is regularly re-evaluated by recognized authorities to ensure our products comply with the appropriate international standards.
But we don’t stop there.
From inviting regular external audits of our supply chain and product sites to securing an unmatched range of international approvals – including GMP, COFRAC, BUREAU VERITAS, and EXCiPACT™ to name a few – we offer our customers the complete confidence they need to create life-saving treatments.
Central Quality Control Laboratory in Lestrem has been awarded the COFRAC accreditation for the analysis of raw materials. Analytical certificates are issued in accordance with food, pharmaceutical and industry standards.
Discover the difference true quality can make.
The markets we serve
A leading pharmaceutical excipients supplier
Unlock the full spectrum of dosage forms with our innovative pharmaceutical ingredients. As a vertically integrated, solution-orientated partner, we deliver true quality to help you tackle the toughest challenges in drug delivery.
Excellence in nutraceutical active ingredients
Underpinned by a fully transparent, vertically integrated supply chain, our range of quality plant-based excipients and APIs make custom dosage forms possible. Achieve your supplement development goals with Roquette..
Superior quality injectable and dialysis solutions
Rely on Roquette to support your injectable drug and dialysis treatments. With a complete portfolio of pyrogen-free ingredients, osmotic agents and specialty APIs, we have the expertise you need to formulate lifesaving drugs.
More about Roquette Pharma Solutions
Browse our products
Looking for a robust excipient or specialty API? Discover our broad and diverse portfolio of quality solutions.
Browse, click, done. Count on our online ordering platform to streamline your product purchasing process (US customers).
Pharma Virtual Lab
Cutting-edge pharmaceutical science at your fingertips. From expert webinars to in-depth whitepapers, get all the insights you need via our virtual innovation hub.