Founded in 2005, COREALIS Pharma Inc is a private company that partners with the pharmaceutical and biotechnology industries for the formulation development and clinical supplies manufacturing of solid oral dosage forms (tablets, capsules, and granules) on a contractual basis.
Complete in-house services from active pharmaceutical ingredient (API) characterization to clinical supplies delivered on time, every time, by an experienced team of professionals applying phase appropriate science and technology to each project.
COREALIS Pharma recognizes the uniqueness of each API, of each therapeutic application, the regulatory requirements of each country, and of each client. Thus, personalized, efficient, and supported service is the priority. Frequent communication, interactions, and follow-ups with clients are of the utmost importance. COREALIS Pharma offers clients the possibility to access, in real-time, the information, data, and documents relating to their projects. Maintaining an appropriate level of contact with clients and providing them with a maximum amount of information to allow them to make informed decisions as the projects are progressing is essential to ensure the client’s success.
COREALIS Pharma’s experts have developed and manufactured a large variety of drug products where numerous formulation strategies and processes have been utilized. Their expertise is made available to clients for the development and manufacturing of the following types of drug products:
- Phase appropriate drug products for early stage clinical studies (API-in-a-bottle, API-in-a-capsule, fit-for-purpose formulations);
- Immediate release;
- Delayed and Sustained Released;
- Gastric protection;
- Combination of 2 to 3 APIs (505(b)(2));
- Reformulation of drug products for new therapeutic applications, new dosage forms or different drug loading (505(b)(2));
- Anti-drug abuse of controlled substances.
Our state-of-the-art laboratories and manufacturing facilities, located in the beautiful Biotech Scientific Park situated in Laval (Québec, Canada), allow our experts to successfully complete the most complex formulation development and clinical supply manufacturing mandates.
COREALIS Pharma’s cGMP facility and processes are in full compliance with the ICH guidelines as well as country specific (US, Europe, and Canada) regulatory requirements for clinical studies to be held under their jurisdiction. COREALIS Pharma is continuously improving its quality systems as they are put under scrutiny on a regular basis by clients’ auditors and Qualified Quality Persons (QP) for clinical studies to be held in various European countries. COREALIS Pharma underwent a successful general audit by a QP auditor. This translates into a substantial time and cost savings, because re-auditing COREALIS Pharma for each manufacturing campaign of clinical supplies for European studies is not required.
Furthermore, COREALIS Pharma has been granted its establishment license from Health Canada for the manufacturing, packaging and testing of commercial pharmaceutical oral solid dosage forms.
COREALIS Pharma’s goal is to provide its clients full satisfaction by providing high quality services in delivering compliant phase appropriate drug products on time, every time.
- COREALIS Pharma R&D and GMP operations are performed in a 3000 m2 (33,000 sq. ft.) dedicated facility that is designed to offer all of the pharmaceutical formulation development and clinical trial material manufacturing services under one roof.
- The GMP manufacturing area is divided in several sub-areas where each has its own HVAC system with a single pass air flow system with HEPA filtration. Areas are equipped for both aqueous and organic processes.
- Laboratories are fully equipped for both chemical and physical characterization, containing, among others, specialized equipment including: HPLC, UPLC, Headspace GC, dissolution equipment, XRPD, DSC, TGA, SEM, particle sizers (microscopy and laser diffraction) and PAMPA.
- The COREALIS Pharma scientists have access to a variety of manufacturing equipments and processes utilized in oral dosage forms for their formulation development projects and GMP clinical supplies manufacturing, such as tabletting, encapsulation, dry/ wet/ melt granulation, spray drying, hot melt extrusion, extrusion/ spheronization.
Your Advantages when working with COREALIS Pharma
COREALIS Pharma prides itself on:
- Its experienced multidisciplinary team with strong expertise;
- Its track record of delivering on time, every time;
- Its speed of execution, flexibility, integrity and transparency;
- Its personalized services.
The COREALIS Pharma team is flexible, responsive, and, above all, efficient. Its employees are competent, motivated, and take personal interest in quickly bringing the phase appropriate drug product to the clinical trials on time, even for the most challenging projects.
Your success comes first – COREALIS Pharma will do its utmost in order to adapt to your needs by providing personalized services and choosing the right technology and methodology to ensure your success.
COREALIS Pharma experts work in state-of-the-art laboratories using equipments & systems in the GMP areas that are fully validated and comply with American, Canadian, and European GMP regulatory authority requirements.
From the constant feedback of clients, COREALIS Pharma believes that it is succeeding in providing outstanding services.
Should you have any questions or comments, please do not hesitate to contact us.
The multidisciplinary professional team at COREALIS Pharma is composed of individuals who possess scientific training, as well as pertinent industrial experience acquired in both the 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 confront the most complex challenges in formulation and analytical development. The three executives, presented below, are also the founders of the company.
YVES ROY, Ph.D., PRESIDENT
Dr. Roy holds a B.Sc. and M.Sc.in biology from the Université du Québec à Montréal and a Ph.D. in toxicology from the Université Catholique de Louvain. Early in his career he took on several management and business development positions for various contract research organizations (CRO). In 1999, he concentrated his efforts on the business development of start-up companies and new departments of existing companies putting forward pharmaceutical services and emerging technologies to large pharmaceutical companies in order to support their R&D operations. As such, he has been closely involved with the numerous challenges that pharmaceutical start-ups face. His scientific knowledge, understanding of the pharmaceutical R&D environment, sense of business development and experience in the management of small size private and public companies are an asset to COREALIS Pharma.
PATRICK GOSSELIN, Ph.D., VICE-PRESIDENT – PHARMACEUTICAL R&D
Dr. Gosselin handles formulation and process development of new chemical entities as well as phase I/II clinical trial material manufacturing. He received his Bachelor’s degree in Chemical Engineering and his Ph.D. in Pharmaceutical Technology from the University of Montreal, Canada. Past professional experiences consist of pharmaceutical development consulting to several pharmaceutical companies, as well as senior scientist and project leader within the R&D department of the former German multinational firm ratiopharm acquired by Teva. 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. Finally, he is associate professor at the University of Quebec in Montreal and has published several peer-reviewed publications and formulation patents.
YVES MOUGET, Ph.D., VICE-PRESIDENT – ANALYTICS
After obtaining his B.Sc. from Concordia University and his Ph.D. from the Université de Montréal, Dr Mouget joined MDS Sciex as a research and application chemist, developing his understanding of R&D work in the pharmaceutical environment. In 2000, he accepted the position of R&D director at Pharmalaser, further developing his instrumentation and R&D skills. In 2003, he joined the German firm, ratiopharm, as director of analytical development, which placed him at the heart of the pharmaceutical development process. In the course of his studies and his career, he has collaborated with research centers throughout the world, and presented and published several papers. This has provided an appreciation of the multifaceted analytical, technical, logistical, and regulatory challenges and requirements of bringing pharmaceutical products to the market.