Oral drug development and manufacturing

Oral drug development and manufacturing

Meaningfully integrated and engineered to bring your oral drug to clinical trials quickly and reliably, we have the capabilities and expertise to handle any of your oral drugs and guide your development journey.

Committed. Reliable. We accelerate your path to success while ensuring robust support at every stage.

Crafting a science-led route to the clinic

Our expert team and integrated platform are uniquely built to support and guide your early phase oral drug to the clinic, through clinical studies and into commercialization.

Small-scale manufacturing is what we do best. We offer dedicated capabilities for the development and production of oral drugs including powders and liquids in capsules, immediate or modified-release tablets, orally disintegrating tablets, solutions and suspensions. We also have a unique range of delayed or controlled release technologies that are used to develop monolithic or multi-particulate matrix-type and reservoir-type systems.

We use the right standards at the right development phase to support successful regulatory filings guided by a dossier-oriented approach paired with long-standing regulatory knowledge.

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Oral drug development and manufacture

Oral Dosage Forms

  • API in capsule
  • Powder blend in capsules
  • Liquid in capsules
  • Immediate or modified-release tablets:
    • Monolithic dosage forms
    • Multiparticulates
    • Gastro retentive tablets
    • Osmotic tablets
  • Mini tablets
  • Orally disintegrating tablets
  • Sachets
  • Solutions and suspensions
  • Pediatric oral dosage forms

Capabilities/equipment

  • Blending
  • Spray Drying
  • Hot Melt Extrusion
  • Dry and wet granulation
  • Fluid bed granulation
  • Twin-screw granulation
  • Capsule filling (API, powder, liquid or tablet in capsule)
  • Tableting
  • Tablet coating
  • Primary packaging (cold or thermoformable blisters and bottles)
  • Secondary packaging and labeling

Delayed or controlled release technologies

Delayed or controlled release technologies
  • Bead coating
  • Spray drying
  • Hot Melt Extrusion
  • Minitablet compression
  • Matrix tablet compression
  • Tablet coating

Non-GMP and GMP manufacturing:

Non-GMP and GMP manufacturing:
  • Pre-clinical batches
  • Pilot batches
  • GMP clinical batch supply
  • Scaling from grams – 60 kg per batch

Related Resources

Our expert team members share deep, scientific understanding and insights into oral drug development and manufacturing.

See all resources
On-demand webinar: Capsules, a versatile OSD for early phase development
Webinars

On-demand webinar: Capsules, a versatile OSD for early phase development

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# Drug Product Oral Drugs
Facilitating clinical trial success for drug products
Info sheets

Facilitating clinical trial success for drug products

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# Drug Product Oral Drugs

Our integrated platforms

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.

Drug substance

Helping you turn your compounds that show promise into GMP-grade drug substances.

Drug product

We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.

Drug product

We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.

Drug product

We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.