SERVICES

Rubicon Research Canada offers comprehensive drug product formulation and process development, as well as wide-ranging analytical testing services to the pharmaceutical industry, specializing in nasal and pulmonary drug products.

Rubicon Research Canada is well-positioned and experienced to support virtual, mid-size, and multinational companies by providing reverse engineering and novel formulation development solutions, manufacturing and packaging solutions, and associated analytical and stability support services.

 

CAPABILITIES

Reverse Engineering of Products

Formulation, Process Development, and Pilot Scale-up

Management of CMO (Technology Transfer and Submission Batch Manufacturing)

Full Release Testing, Stability Studies, and Temperature Cycling Studies

Characterization and In-use Studies

In vitro Bioequivalence Studies

Regulatory Support

Proof of Concept  Studies

"Lungs diagram with internal details" by Patrick J. Lynch, used under CC BY 2.5. .

Patrick J. Lynch, medical illustrator

Permission details

Creative Commons Attribution 2.5 License 2006

 

EXPERIENCE

Developed seven Rx FDA-approved products, including four generic CFC pMDI products for the U.S. market

Partnered with top U.S. and Canadian pharmaceutical companies to develop nasal sprays (solutions and suspensions) for both markets

Met the in-vitro bioequivalence criteria for all products developed to date

Developed products for United Nations development program to help transfer the pMDI products from CFC propellant to HFA for the developing nations

Successfully developed generic nebule and ophthalmic products

 

PRODUCTS

Pressurized Metered Dose Inhalers (pMDIs)

Metered Nasal Sprays

Small Volume Nasal Sprays (e.g. unit dose)

Topical Sprays

 

GET IN TOUCH:

CONTACT US:

Tel: +1 (905) 760-0232

Email: bd@rubicon-canada.com

255 Spinnaker Way, Unit 6,
Concord, Ontario, Canada L4K 4J1