Corealis Pharma Contract Formulation Development and Clinical Trial Manufacturing Services for Oral Solid Dosage Forms

As a privately owned company located in Montreal, Canada, Corealis Pharma assists small and medium pharmaceutical companies in their pharmaceutical development needs by offering a complete line of services for formulation development and phase I and II clinical trial manufacturing of oral solid dosage forms.

Increase the market value of your company and its attractiveness to investors by involving Corealis formulators early in your drug development process.

Phase I and phase II CTM manufacturing

The company prides itself on providing personalized services with fast project start-up and 100% on-time delivery. The entire team has relevant background, expertise and experience, and can rely on modern and well-equipped laboratories. Since the inception of the company in 2005, over 200 drug products have been successfully developed and more than 65 phase I and phase II CTM manufactured.

Integrated pharmaceutical development and manufacturing

Corealis has all of its activities and operations in one location, a new 35,000ft² state-of-the-art R&D formulation development, analytical laboratory, and manufacturing facility fully compliant to EMEA, USFDA and Health Canada GMP requirements.

Formulation development of new chemical entities

Corealis develops formulations of new chemical entities for the manufacturing of phase I and II clinical supplies for Canadian, US and European submissions. This service is specifically designed for biotech companies.

Using final or close to final dosage forms in pre-clinical and clinical trials greatly reduces the chance of failure and costly justification in submissions.

Pharmaceutical product development and manufacturing services

Corealis can undertake complete pharmaceutical product development or provide companies with very specific development steps such as:

  • API characterization and salt selection (crystal state, particle size, solvates, hygroscopicity, stability, etc.)
  • Pre-formulation (drug-drug compatibility, drug-excipients compatibility, compressibility, flow, etc.)
  • Formulation and product development: direct compression, wet granulation (high shear and FBG), dry granulation (roller compaction), spray dry (aqueous / solvents), extrusion, spheronization, tableting and encapsulation (dry powder, granules, hot melt, suspension and solution)
  • Analytical method development and GMP testing (assay and related substances, dissolution, etc.)
  • Analytical method transfer
  • GMP stability storage and testing
  • Formulation and process transfer and scale-up
  • Phase I and II cGMP clinical trial material (CTM) manufacturing

Corealis is responsive and flexible, and provides high-quality services to move your compound quickly through the different development steps to regulatory approval.

Make an enquiry

Follow this company

Follow the company to be always up to date with this company

Press Release

Fujifilm to Acquire MSD BioManufacturing Network

Fujifilm Corporation and Merck, known as MSD outside the US and Canada, have announced that they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceut

Address
Corealis Pharma, Inc.

200, boul. Armand Frappier

Laval (Qc) H7V 4A6

Other

Canada

+1 450 973 7505 +1 450 973 7506 www.corealispharma.com

Corealis Pharma Images

Products and Services

Video

White Papers

Press Release

8 March 2011

Fujifilm Corporation and Merck, known as MSD outside the US and Canada, have announced that they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceut

Read more
29 May 2007

ACE Pharmaceuticals today announced that the first patient has entered the Phase III trial also known as the Levamisole trial. This trial was accepted by the EMEA by November 2006. The goal of this trial, which was accepted by the EMEA in November 2006, is to assess the efficacy and sa

Read more

Regional Offices

Corealis Pharma, Inc.

200, boul. Armand Frappier

Laval (Qc) H7V 4A6

Other

Canada

+1 450 973 7505 +1 450 973 7506 www.corealispharma.com

Contact company

I have read and accept the terms and conditions and privacy policy.
We'd like to keep you informed about relevant promotions, products and services, if you would like not to receive these, check this box.
If you would like to hear from carefully selected third party companies, check this box
Follow this company to receive notifications when they update.