REGULATORY AFFAIRS
The Regulatory Affairs component has the responsibility to assess the regulatory requirements and to recommend the implementation of procedures that ensure the compliance of the products marketed and the facilities. In addition, it provides technical support to the compliance monitoring system.
The Regulatory Affairs component is defined as the requirements for the preparation of all documentation needed for new product applications or changes to existing applications in order to obtain the approval of regulatory authorities in the country concerned to market a new product or improve products already approved in this particular market.
It also has the mandate to manage the communications with regulatory agencies of the countries involved in the process of marketing products abroad .
This component also includes the preparation and submission of establishment or site licence applications as well as the products’ labeling aspect.
Our team takes care of assisting companies with those requirements according to the products marketed.
CHOOSE A CATEGORY
PHARMACEUTICALS
Before drugs are approved for sale in Canada, Health Canada evaluates their safety, efficacy and quality. The ‘pharmaceuticals’ segment includes :
PRESCRIPTION AND NON-PRESCRIPTION PHARMACEUTICALS
DISINFECTANTS
SANITIZERS WITH DISINFECTANT CLAIMS
SYLLA CONSEILS INC. offers its expertise to carry out and assist companies in the elaboration of the documentation as well as in the communications with government authorities either:
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PREPARATION OF THE DOCUMENTATION FOR ESTABLISHMENT LICENCE APPLICATIONS
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PREPARATION OF THE DOCUMENTATION FOR DIN (DRUGS IDENTIFICATION NUMBER) LICENCE APPLICATIONS
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ASSESSMENT OF PRODUCTS’ FORMULATION IN ACCORDANCE WITH THE REGULATORY ASPECT AND APPROVAL
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REVIEWING OF LABEL TEXTS
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ANSWERING REQUESTS FROM GOVERNMENT AUTHORITIES
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PREPARATION AND EXECUTION OF QUALITY AUDITS (GMP's)
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CARRYING OUT AUDITS PERFORMED BY REGULATORY AUTHORITIES
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WRITING REPORTS FOLLOWING GOVERNMENT AUDITS & PARTICIPATING IN THE ELABORATION OF RECOMMENDATIONS
We also offer assistance for companies wishing to market generic drugs in US as well as assisting them in the compliance process with GMP's.
NATURAL HEALTH PRODUCTS
In January 2004, the regulation for Natural Health products has entered into force. Health Canada now requires that a product license be issued to authorize the sale of a Natural Health product in Canada. In addition, the Canadian institutions responsible for the manufacturing, packaging, labeling, or the importation of such products must hold a site licence.
To obtain a product or site licence, it is mandatory to meet the requirements in terms of labeling, packaging, and Good Manufacturing Practices (GMP’s) as well as to provide adequate evidence of products’ safety and efficiency.
SYLLA CONSEILS INC. has the expertise and knowledge to help any company wishing:
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A SITE LICENCE
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A PRODUC LICENCE (NPN)
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ELABORATION OF A QUALITY SYSTEM
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NEGOTIATIONS WITH GOVERNMENT AUTHORITIES
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IMPORTATION AND EXPORTATION OF NATURAL HEALTH PRODUCTS
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ASSESSMENT OF PRODUCT’S FORMULATION ACCORDING TO REGULATORY ASPECT AND APPROVAL
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REVIEWING OF LABEL TEXTES
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PREPARATION AND EXECUTION OF QUALITY SYSTEM (GMP’S
COSMETICS
All cosmetics sold in Canada must be safe to use and must not pose any health risk. They must meet the requirements of the Food and Drug Act and the Cosmetic Regulations.
Cosmetics sold in Canada must be manufactured, prepared, preserved, packed and stored under sanitary conditions. The manufacturer and importer must notify Health Canada that it is selling the product and must provide a list of the product's ingredients. Additionally, cosmetics are subject to the requirements of the Consumer Packaging and Labeling Act and Regulations.
SYLLA CONSEILS INC. offers to companies any assistance necessary to comply with all regulatory aspects either:
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NOTIFICATION OF COSMETICS
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ASSESSMENT OF PRODUCT’S FORMULATION ACCORDING TO REGULATORY ASPECT AND APPROVAL
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REVIEWING OF LABEL TEXTES
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IMPORTATION AND EXPORTATION OF COSMETICS
VETERINARY PHARMACEUTICALS
Pharmaceutical products for veterinary use must also be approved in advance in order to be authorized for sale in Canada.
SYLLA CONSEILS INC. offers its service to assist you with:
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PREPARATION OF THE DOCUMENTATION FOR ESTABLISHMENT LICENCE APPLICATIONS
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PREPARATION OF THE DOCUMENTATION FOR DIN (DRUGS IDENTIFICATION NUMBER) LICENCE APPLICATIONS
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ASSESSMENT OF PRODUCTS’ FORMULATION IN ACCORDANCE WITH THE REGULATORY ASPECT AND APPROVAL
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REVIEWING OF LABEL TEXTS
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ANSWERING REQUESTS FROM GOVERNMENT AUTHORITIES
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PREPARATION AND EXECUTION OF QUALITY AUDITS (GMP's)
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CARRYING OUT AUDITS PERFORMED BY REGULATORY AUTHORITIES
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WRITING REPORTS FOLLOWING GOVERNMENT AUDITS & PARTICIPATING IN THE ELABORATION OF RECOMMENDATIONS
MEDICAL DEVICES
In Canada, medical devices are classified into classes from I to IV according to the risk level associated with their use. Class I devices represent the lowest potential risk and Class IV devices represent the highest potential risk. Medical devices of Class II, III and IV must be approved (must be licensed) to be imported or sold in Canada.
Although medical devices of Class I do not require any approval, manufacturers, distributors and importers must obtain an establishment license.
In addition, the Medical Devices Regulations require Class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485.
SYLLA CONSEILS INC. offers to its clients to carry out the applications:
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PREPARATION OF THE DOCUMENTATION FOR ESTABLISHMENT LICENCE APPLICATIONS
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VERIFICATION OF THE DEVICE’S CLASS TO BE APPROVED
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PREPARATION OF THE DOCUMENTATION FOR MEDICAL DEVICES LICENCE APPLICATIONS
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NEGOTIATIONS WITH GOVERNMENT AUTHORITIES
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REVIEWING OF LABEL TEXTS
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DEVELOPMENT AND MONITORING OF A QUALITY MANAGEMENT SYSTEM (ISO 13485)
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CARRYING OUT THE AUDITS PERFORMED BY AUTHORIZED REGISTRARS FIRMS.
The classification of medical devices is different in US and Europe. SYLLA CONSEILS INC. offers support to its customers when approaching foreign authorities.
FOOD PRODUCTS
The Canadian Food Inspection Agency uses a risk-based approach to ensure that products manufactured in Canada and imported products meet the standards and the Canadian regulations. Compliance and enforcement of the law concern the whole supply chain and target a large number of stakeholders and skills.
SYLLA CONSEILS INC. is happy to collaborate with any company wishing to ensure compliance as regards to labeling and Good Manufacturing Practices (GMP’s).
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ASSESSMENT OF PRODUCTS’ FORMULATION IN ACCORDANCE WITH THE REGULATORY ASPECT AND APPROVAL
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REVIEWING OF LABEL TEXTS
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PREPARATION AND EXECUTION OF QUALITY AUDITS (GMP's)
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CARRYING OUT AUDITS PERFORMED BY REGULATORY AUTHORITIES