Validapro
Validapro is a consulting firm specializing in projects
requiring regulatory conformity for the pharmaceutical and
biotechnological industries. The Validapro subsidiaries
Validapro International, Pharma Concept, TechniCal and DRG
Environnement provide the necessary support from project
design to completion, and ensure compliance with regards to
Canadian (HPB), U.S. (FDA) and European (EMEA) regulations.
By integration a wide range of expertise in engineering,
calibration, preparation of operating procedures, installation
and validation, Validapro can offer a turnkey solution.
The Validapro offices are located in the greater Montreal area,
in the suburb of Laval. At the present time, Validapro has
customers in North America, South America, Europe and the Middle
East. The Company, established in 1993, consists of professionals
offering engineering and toxicology. These professionals have
many years of experience in the pharmaceutical and biotechnology
industries. This multidisciplinary team allows Validapro to
offer the expertise which can help your achieve your project
goals, regardless of the project scope.
Summary
Founded in 1993 in Laval by Mr. Luc Dubois, Validapro had, as
an initial mandate, to offer theoretical and applied expertise
in the field of validation. With more than 10 years of experience
in this field, Mr. Dubois surrounded himself with specialists
throughout the growth of Validapro. In 1995, Mr. Pierre Rousseau
joined the Company as an associate. Mr. Rousseau also had many
years of experience in validation and compliance in pharmaceutical
industry. In 1996, Mr. Jean-Pierre Garipy became an associate
of the group and added his numerous years of experience in
management and development of business. In conclusion, in 1997,
Mrs. Brinda Isings joined the group as an associate of Pharma
Concept, bringing with her many years of experience in
pharmaceutical engineering. Besides its associates, Validapro
has seen the number of employees increase dramatically in the
past years, each individual bringing various capabilities which
permit Validapro and its affiliates or offer a large variety of
services and know-how.
Recently, Validapro restructured its operation by segregating
the different aspects of its operations : Validapro International
is dedicated to validation and compliance, Pharma Concept offers
support in the engineering area, TechniCal offers calibration
programs and, DRG Environnement offers support in environmental
compliance.
Company Details
Year Established:
1993
Total Sales ($CDN):
$100,000 - $200,000
Number of Employees:
21
Company Information
Luc Dubois
Title:
President
Telephone:
(450) 668-1144
Fax:
(450) 668-1797
Email:
Click Here
Services
Validation
Training
Our company offers a variety of training courses : Good
Manufacturing Practice (GMP), validation, environmental control,
and technical elements related to pharmaceutical, biotechnology
or medical instruments industries. Validapro is available to
offer courses entirely adapted to your needs.
Audits
With the many years of experience that our personnel have in
this field, the team members of Validapro could assist you in
the evaluation of the industry's situation with regards to
applicable regulations and in the issuance of a complete report
including the appropriate corrective measures. Our expertise
includes knowledge of the Canadian, American, and European
regulations, as well as the ISO Standards, in the pharmaceutical,
biotechnology and medical instruments fields.
Design
Through its affiliate, Pharma Concept, offers the necessary
expertise to assist you in the design of new installations or
new procedures. With its experienced engineers, and with the
complex requirements that have to be met in the regulated
industries such as pharmaceutical, biotechnology and medical
instruments, Validapro and Pharma Concept offer all the
necessary support in the preparation and/or the review of
estimates, specifications or flow diagrams.
Auditing Of Equipment Suppliers
Auditing of Equipment Suppliers and Factory Acceptance Tests
Validapro, through its affiliate, Pharma Concept, is able to
audit suppliers of important equipment such as sterilizers,
freeze dryers, or any other equipment which plays an important
role in your industry. Pharma Concept is also able to develop
protocols necessary to conduct supplier inspection (Factory
Acceptance Test).
Technical Programs
Technical Program and Calibration and Preventive Maintenance
Programs
Validapro, through its affiliate, Pharma Concept, can develop
the pharmaceutical manufacturing processes, prepare process
flow diagrams, and prepare plant technical programs. Pharma
Concept can also develop and put in place calibration and
preventive maintenance programs which will allow you to meet
all the regulatory standards while maintaining simplicity and
flexibility.
Issurance Of Operating Procedures
Validapro and Pharma Concept offer you the necessary support
in the issurance of procedures. Be it the Standard Operating
Practice (SOP) or technical operating procedures, we can offer
you the essential expertise to develop clear, detailed procedures,
which meet all the applicable regulations.
Calibration
Validapro, through its affiliate, TechniCal, offers a complete
calibration program specialized for the pharmaceutical,
biotechnology and medical instruments industries. TechniCal
assures you all the necessary characteristics in order to meet
the regulations of these industries : complete calibration
certificates, written and approved calibration methods;
calibration references of known organizations. In addition,
TechniCal is able to calibrate in-place or in our workshop.
In conclusion, TechniCal is able to manage your entire
calibration program with the help of the latest management
calibration software.
Biotechnology