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ACCELERATING SMALL MOLECULE API MANUFACTURING

Actylis can provide a custom solution to your small molecule API manufacturing challenges

Actylis offers a comprehensive range of services to support our customers, leveraging our expert teams and state-of-the-art facility in Eugene, OR.

  • Route Scouting
  • Analytical Method Development
  • Process Development
  • Analytical Method Validation
  • Non-GMP Manufacturing
  • RSM Manufacturing
  • Phase 1/2/3 API Manufacturing
  • Process Validation
  • Small Scale Commercial Manufacturing
LET US HELP YOU
Hero Shot 11 - Actylis Eugene (USA) - Alice Maidment (Chemical Operator) purple
Industries that can benefit from our services include Pharmaceuticals, Medical & Dental Devices, Specialty and Commodity Chemicals, as well as other industries that might require custom chemical manufacturing.

Regulatory Compliance

Actylis’ team of experts are available to support compliant manufacture of chemical processes in many industries and project phases. Our Quality team is experienced in phase-appropriate cGMP compliant manufacturing of APIs from Phase 1/2 to Phase 3 & small-scale Commercial production. Our experts can maintain compliant manufacturing on projects in the pharmaceutical, excipient, and medical/dental device industries as well as supporting manufacture of DEA schedule II-III substances. Our expert quality team will go the extra mile to support compliant manufacturing of any project in any industry.

Clinical Trial Support

Actylis understands that a strong manufacturing partner is essential for any candidate to progress through clinical trials and for any commercial product to be launched. We provide world-class R&D leadership, manufacturing expertise, and project management to ensure that essential materials are delivered on time & on budget.  We allow unprecedented access to project teams & scientist to ensure that there is a constant stream of communication and that IND enabling studies are seamlessly conducted and documentation is readily transferred. 

Analytical Services

The Analytical team at Actylis is experienced at in-depth analytical problem solving. A new and modern fleet of instruments allows the team to solve problems using LCMS, HPLC (DAD, ELSD, CAD, etc), GPC, GC, KF, and TGA to interrogate a huge number of questions on molecular purity and impurities identification. The team produces validated, stability indicating, analytical methods for all phases of API development and supports projects in all industries with production of reliable analytical methodology. 

Actylis can accelerate your timeline

Actylis' services are uniquely tailored to accelerate our customers' manufacturing timelines. This is how we do it:

  • Customer focused project leadership team
  • Nimble & responsive organization and leadership team
  • Large and experienced synthetic and analytical development teams
  • Standardized workflow
  • Flexible & expert manufacturing group
  • Broad experience in quality and regulatory considerations
  • World-class Project Management

Actylis has a US-based CDMO facility specialized in innovative APIs. Unlike many CDMOs that prioritize late-stage projects, we uniquely focus on the crucial early stages of your programs, often overlooked by others in the industry.

We've engineered our organization and processes to deliver unparalleled speed and quality, setting new benchmarks in the market. Our commitment to excellence has made us the go-to strategic partner for clients seeking rapid and reliable preclinical development and scale-up solutions.

With Actylis, you can trust that your early-phase programs will receive the attention they deserve, ensuring faster timelines and adherence to budgetary and cashflow constraints.

The expert team of synthetic and analytical chemists at Actylis is equipped to handle any custom chemical manufacturing or pharmaceutical manufacturing project. Our new state-of-the-art cGMP compliant CDMO facility is located in the USA where we can handle GMP, non-GMP, excipient, RSM, and API (Active Pharmaceutical Ingredients) manufacturing projects in all stages of process development, from route scouting to commercial manufacturing. 

A state-of-the-art cGMP compliant API manufacturing facility ensures that pharmaceuticals, RSMs, and custom chemicals are manufactured to the highest possible standards and a phase-appropriate quality system allows accelerated early phase process development, process validation, and commercial manufacturing from a single contract development and manufacturing organization. 

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PLEASE SUBMIT THE FORM FOR YOUR INQUIRY | We are eager to learn about your project and to have the opportunity to work with you.

 Why Choose Actylis | Flexibility & Expertise

We understand that technical challenges can be complex and time-consuming for industries like ours which are continually under pressure to deliver more at higher quality. Actylis is a leading US based CDMO who works with companies like yours that are frustrated with over extended development timelines.  We offer a range of services to help you solve challenges quickly and efficiently. Our experts have the skills and knowledge to provide you with the solutions you need to make informed decisions, improve your operations, & speed up your timeline. 

Many CDMO are unwilling to focus on small volume or early stage projects, or do not give these projects the attention they deserve. Actylis has been built to focus on small volume and early stage projects & our customer centric approach allows us to foster expert to expert relationships and has enabled us to build trust with multiple local and multinational institutions over time. This, combined with modern, well-equipped facilities enables us to deliver custom solutions at unparalleled speed.