Company Overview

 

 

Overview:

As a private company founded in 2005, COREALIS Pharma is a partner to the pharmaceutical and biotechnology industries for the development of solid dosage forms (tablets, capsules, and granules).  The experts of COREALIS Pharma have access to well-equipped laboratories and manufacturing facilities, allowing them to successfully complete the most complex formulation and process development mandates.

 

Site features :

  • Total facility space of 33,000 sq. ft., more than half of which is dedicated to both an R&D and a GMP laboratory space and the GMP manufacturing area.

  • The GMP area contains 3 units with 4 manufacturing suites each, single pass air flow system, HEPA filtration, equipped for both aqueous and organic processes

  • Fully equipped laboratory for both chemical and physical characterization, with amongst other specialized equipment: refractive index detector, fluorescence detector, XRPD, DSC, Particle size determination by microscopy and laser defraction

 

Site Advantages :

  • Fully integrated contract research services in pharmaceutical product development and clinical trial material manufacturing;

  • Excellent operational efficiency;

  • Total quality control and process.

 
     
     

Services:

  R&D activities for the development of pharmaceutical solid dosage forms on a contractual basis.

  Use of a variety of manufacturing technologies for a complete range of pharmaceutical solid dosage forms (tablets, capsules, and granules) for the manufacturing of clinical trial materials.

  TURN-KEY projects; Provide complete project development of a finished product.

 

 

  SPECIFIC projects; Perform one or several phases during the product development process.
   

 

  
Benefits:

  Expertise and experience of our multidisciplinary team

  Information supplied as per Client needs

  Speed of execution, flexibility, precision, scientific integrity, transparency

  Awareness of the particular needs of the pharmaceutical industry (cGMP, regulatory requirements, legal aspects – patents)

  Modern formulation and analytical laboratories

  Appreciation of cost and timeline requirements
 
   

Clients:

 

 

 

 

 

 Biotechnology companies

- Proof of concept

- Pre-formulation

- Formulation for toxicology and clinical studies

  Branded pharmaceuticals

- Formulation for a new chemical entity
   
     

Management

team:

 

The professionals at COREALIS Pharma each possess a unique scientific training, as well as pertinent industrial experience acquired in both pharmaceutical manufacturing and service industries. They have successfully submitted several products for approval to American, Canadian and European regulatory agencies.  This experience makes it possible for them to face the most complex challenges in formulation and analytical development.

 
     
 

Yves Roy, Ph.D., PrEsident
Since 1981, Dr. Roy has taken on several management and business development positions for various contract research organizations (CRO).  Starting in 1999, he has concentrated his efforts on the business development of new departments putting forward pharmaceutical services and emerging technologies offering new solutions to pharmaceutical R&D and production.  As such, he has been closely involved with large variety of pharmaceutical R&D and manufacturing projects.  He has also been exposed to the problems and the technical, commercial, and regulatory requirements of the industry.  His scientific knowledge, his understanding of the pharmaceutical R&D environment, his sense of business development and his experience in business development are an asset to the enterprise.

     
 

Patrick Gosselin, Ph.D., Vice-president, pharmaceutical R&D
 Dr. Gosselin has several years of experience in formulation, technological transfers, and the troubleshooting of solid dosage form manufacturing.  Dr. Gosselin was a consultant in pharmaceutical development to several pharmaceutical companies.  In 2003, he takes the position of senior scientist and project leader within the R&D department of the German multinational firm ratiopharm.  Therein, he has contributed to the development and the submission of numerous products and was actively involved in the establishment of a centre of excellence in R&D for ratiopharm international.

     
 

Yves Mouget, Ph.D., Vice-president, analytics
Dr. Mouget started his career in 1997 when he joined MDS Sciex as an LC/MS research and application chemist for pharmaceutical bio-analysis.  In 2000, he accepted the position of R&D director at Pharmalaser.  His collaborations with several research centres throughout the world have given him the opportunity to work on numerous analytical challenges involving both existing products and products under development.  In 2003, he joined the German multinational firm ratiopharm as director of analytical development, which placed him at the heart of the pharmaceutical development process, amongst others the technical, logistical, and regulatory requirements of bringing products to the market.