Contract Development & Manufacturing (CDMO)is a pilar service we have been offering for more than 20 years alongside with experience, agility, innovation, and regulatory expertise in inorganic and organic salts.

We harness this experience and a state-of-the-art facility that includes diverse teams of highly experienced scientists and regulatory technicians to collaborate with you on a tailored project.

Contract-Development-and-Manufacturing-CDMO

We are committed to executing projects seamlessly through maintainingoptimized & cost-effective manufacturing过程不透明也不妥协quality.

Benefits of our CDMO Service

Equipment

Our manufacturing facilities located in Barcelona & Palencia, Spain, are multifaceted and capable of accommodating synthesis, solvent distillation, purification, drying, milling, mixtures, and solutions, all thanks to the vast extent of equipment readily available to undertake a broad range of chemicals, from hazardous materials to controlled substances.

Process analytical technology

We offer tailor-made analyses to suit your specifications thanks to the following technologies: 1) HPLC 2) ICP-MS and ICP-OES 3) GC 4) XRD 5) Microbiology testing 6) PSD Analyzer with Wet & Dry accessories 7) FT-IR, and UV-VIS 8) Karl Fischer.

Scalable

Varying in functionality and size, giving you the advantage to take the production from kilo-lab to industrial scale, depending on the size of your demand.

Outsourcing Manufacturing

Allowing you to redistribute internal resources and dedicate them to more valuable competencies and areas in need of improvements.

Analytical Techniques

Our extensive experience spans the development & validation of analytical methods, elemental impurities, residual solvents analysis, cleaning validations, and more.

Quality Control

Using our analytical method development procedures, we can tackle any analysis roadblock to ensure a product complies with the standards you require.

R&D Team

From troubleshooting to optimizing, there is no task too small or too big to handle. Specialising in in-house developments, we onboard seven projects per year focused on new product synthesis. The R&D team runs trial and error protocols on different route of synthesis, finds the best raw materials, optimises methods, performs lab synthesis, and works with our operating team to ensure the upscaling goes smoothly.

Regulatory Support

Recognized by worldwide health authorities such as the FDA, AEMPS, MHRA, EU, PMDA, CDE, and TW-FDA. Our dedication has allowed us to successfully register more than 35 APIs and obtain CEPs, ASMFs, JP-DMFs, and US-DMFs. When documents do not need to be submitted, we can offer other documentation (SDS, BSE/TSE, Stability, etc.) with an informative summary of our data verification protocol.

Quality Systems

Both of our facilities are certified with GMP, ISO 9000, 14000, 22000, 45000, GMP+, and FDA approved. These allow us to foster production dedicated to regulation restricted industries for Active Pharmaceutical Ingredients (APIs), excipients, intermediates, starting materials, and industrial products suitable for the pharma, biotech, oral & personal care, cosmetics, and industrial sectors.

CDMO Service Outline

Our service starts with you selecting us as yourreliable CDMOand taking advantage of our know-how.

The service outline includes 10 steps that are modified based onGMP or non-GMP(ISO) requirements of the project.

Our priority is to align with your expectations in terms of specifications, regulatory support, timeline, and cost.

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Portfolio Scope

Our product portfolio of mineral salts includes the following elements:

How can our CDMO service help you advance?

Get in touch with us to discuss taking-on your project.