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Eurofins Advantar

5451 Oberlin Drive #100
San Diego, CA 92121
USA

Phone: +1 858 228 7788

Email: pha@eurofinsUS.com

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Advantar

Eurofins Advantar provides analytical and formulation development expertise with respect to virtually all dosage forms and API’s ranging from small molecules (organic and inorganic) to peptides, proteins, DNAs and RNAs. Our GLP and cGMP-compliant lab services encompass Toxicology Test Article preparation and testing, Pre-formulation, Formulation Development, Analytical Method Development & Validation, QC release and stability, Clinical Trial Material Labeling/Packaging/Logistics and Regulatory/Technical Consultancy. Eurofins Advantar has also added 1,500 ft2 of non-sterile manufacturing capabilities.

  • Formulation Development & Optimization
  • Analytical Development & Validation
  • GMP Manufacturing (Non-Sterile)
  • QC Release and Stability Testing
  • Clinical Trial Material Labeling, Packaging, and Logistics
  • Technical & Regulatory Consultancy
  • Early Phase Development Solutions

Accreditations/Certifications/Registrations:

  • FDA audited
  • GLP

Eurofins Alphora

2395 Speakman Drive, Suite 2001
Mississauga, ON  L5K 1B3
Canada


Phone: +1 905-403-0477

Email: Eurofins.CDMO@alphoraresearch.com


Eurofins Alphora provides Active Pharmaceutical Ingredient (API) technology development services for the scale-up of complex small molecules with pharmaceutical applications including high potency and cytotoxic compounds.

Eurofins Alphora is an FDA inspected and approved Contract Development Manufacturing Organization (CDMO), with facilities that include cGMP Kilo Laboratories, cGMP Manufacturing Plant operations, and Organic and Analytical Laboratories, and supporting QC/QA functions for a total of 51,000+ square feet.

A second Manufacturing Plant is scheduled to go online August 2017 to provide additional manufacturing capacity.

Founded in 2003, Eurofins Alphora has established a key management team with over 250 years of combined experience, plus a team with considerable talent and notable success in developing and successfully implementing API technologies for hundreds of pre-clinical and clinical compounds.

Services:

  • Process Development
  • DOE and QbD
  • Analytical Development and Validation
  • Stability Testing
  • Gram to Kilogram synthesis
  • GMP and non-GMP
  • High Potency and Cytotoxics
  • Fast Track services
  • Flow Chemistry

Accreditations/Certifications/Registrations:

  • GMP-compliant
  • FDA audited (compliant rated)
  • Health Canada audited (compliant rated)

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