Expertise and technology to
guide you from concept to cure

Curia offers scalable science and personalized expertise with end-to-end API research and development capabilities.

Rely on our best-in-class CDMO offering

The power of a partnership with Curia from discovery to commercial manufacturing

Solutions

Accelerate your product to market

Chemical process development network

Chemical process development

Rely on our chemical process development network of 150+ scientists, global facilities, and the latest technologies

  • Efficient route scouting, rapid process development, and optimization of reaction conditions
  • Scalable manufacturing processes from preclinical to GMP manufacturing
  • For both high-potency APIs and DEA-licensed controlled substances
Fermentation

Dedicated manufacturing facilities and a strong portfolio of steroids and hormones.

Drug substance and drug product formulation development

Comprehensive services and 30+ years of experience

Helping you identify risks and manage the complexities of bringing molecules to market

Analytical method development and material release services

Reliable regulatory, chemistry and advanced instrumentation expertise to support your analytical method development.

A skilled team working under cGMP to deliver consultative reports and protocols.

Separation science

We deliver separation services across the drug development continuum.

  • Classic and chromatographic techniques for the isolation of controlled substances and potent compounds
  • Purification and chiral resolutions for APIs and intermediates – from gram to kilogram scale

We are a trusted global partner for the API commercial supply

Fermentation services

Combined state-of-the-art facilities and process teams with clinical to commercial scale manufacturing

Backward-integrated to fermentation for certain steroidal and hormonal intermediates

High-potency manufacturing services

Whether you need grams or kilograms per year, our team offers expertise in the production, handling and containment of cytotoxic and highly potent compounds.

API manufacturing from clinical scale to commercial scale

Broad range of complex APIs – from generics and potent and cytotoxic compounds, to sterile APIs, steroids and controlled substances.

Small-scale manufacturing ›

Small-scale manufacturing integrating process development, analytical development, clinical-scale API manufacturing, drug product manufacturing, and sterile fill-finish services.

Commercial production ›

Commercial production network delivers global, world-class facilities and a portfolio of generic and commercial APIs.

Complete suite of sterile fill-finish services

Integrating your drug product manufacturing needs at any scale and for all sterile dosage forms.

Regulatory

Clear your path from concept to candidate

Proven track record

257

Commercial products

1,000+

Proprietary DMFs across global markets

100+

Regulatory inspections pass in the last 5 years

Proven track record in regulatory support

Our track record for quality is proven with thorough compliance with the FDA, EMA, PMDA and other regulatory agencies and more than 550 API dossiers filed worldwide.

  • Global filing support
  • CMC module authoring (drug substance and drug product)
  • Certificate of Suitability (CEP) authoring and maintenance
  • Pre-IND and pre-NDA/ANDA meetings, Type C meetings, etc.
  • Consulting and deficiency management
  • Site registrations, U.S. Agent services
  • Publishing services (eCTD)
  • DEA registrations
  • DEA consulting
  • Quota requests
  • Determination requests
  • Researcher protocols

API manufacturing journey

Whatever your complex API manufacturing journey looks like, our regulatory team is here to help you succeed.

Diverse program experience

Diverse program experience across emerging and established modalities, such as mAbs and mRNA, demanding specialized and complex regulatory support.

Integrated teams between small molecule

Integrated teams between small molecule and biologics leveraging each other’s expertise and global regulatory authority relationships.

Resources

Learn more

Curia is a Contract Development and Manufacturing Organization with over 30 years of experience, an integrated network of 29 global sites and over 3,500 employees partnering with customers to make treatments broadly accessible to patients. Our biologics and small molecule offering spans discovery through commercialization, with integrated regulatory and analytical capabilities. Our scientific and process experts and state-of-the-art facilities deliver best-in-class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate and sustain life-changing therapeutics.