By drawing upon its extensive experience working directly with regulatory bodies and by collaborating with your company to develop a regulatory strategy that best fits your requirements, Atinza will assist you in submissions involving new drug entities, second market entries, new dosage forms, new drug delivery systems, new routes of administration, new dosage strengths, new claims, traditional herbal medicines, homeopathics, Rx and OTC products.
Insight into regulatory requirements for natural health products, including advertising, clinical trials, compliance, adverse reaction reporting, and product and site licensing. Discover how you can bring your products and facilities into compliance with current regulations and get your products into the markets as quickly as possible.
We understand the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to Canadian markets. Atinza can assist you in moving your innovation to the market. Throughout our relationship, we will continue to understand your unique needs, meet your specific requirements, and deliver products and services that best address your particular requirement.
Atinza provides extensive regulatory support and advice to bring cosmetics to market. We recommend for testing, safety and labeling. We can work with your product development teams and R&D staff to improve speed to market and compliance with all applicable regulations. Atinza has a wealth of experience and readily available experts who can support your company on all aspects of compliance with the Cosmetics Regulation, including data requirements and testing strategies, nano materials, labeling and product claims.
The food and beverage industry is experiencing more complex challenges than ever before. Facing increased regulatory scrutiny, including the Safe Food For Canadians Act, entities in the food industry are struglling to figure out how they can best comply with the new regulations. Atinza can quickly and efficiently isolate only those regulations that pertain to your food and beverage products, to ensure that your products are in complete compliance with applicable regulations.
To protect consumers from hazards posed by consumer chemical products which are manufactured, advertised, imported or sold on the market and to enable customers to make informed choices about the products they buy and use, we will ensure all ingredients in your products are allowed as per current regulations, and at the specified concentrations, obtaining technical safety data / literature acceptable and all labeling requirements are met.
The one stop service for all your regulatory affairs requirements
Benefits of early regulatory guidence and well-planned regulatory strategy:
Healthcare product development is complex. It is critical to know the general product development lifecycle so that you can follow the correct path. A well-planned regulatory strategy document should be balanced, realistic and achievable to support the your company’s mission and vision. Upon supporting you through the maze of regulations, competing products, therapeutic markets or clinical practices, we ensure your healthcare product will be on the right path to achieve approval from Health Authorities in due time.
Atinza provides comprehensive and flexible solutions for close monitoring of drug safety pharmaco/device vigilance and risk management during the complete lifecycle of a medicinal or medical device product.
Our team of experienced drug safety specialists will process the intake, processing and reporting of Product Quality Complaints, Lack or Loss of Efficacy reports, in the post-marketing phase of the drug life cycle, Individual Case Safety Reports (ICSR), Serious Adverse Events (SAE), Adverse Drug Reaction (ADR), pregnancy and other clinical/spontaneous cases of interest, while guaranteeing accurate coding and reconciliation with clinical databases.
The site licensing system requires that all manufacturers, packagers, labellers, and importers of Natural Health Product (NHP) be licensed. Sites must have procedures in place for distribution records and product recalls and for the handling, storage and delivery of their products. They must also demonstrate that they meet good manufacturing practice requirements. Good Manufacturing Practices (GMPs) must also be employed to ensure product safety and quality.
We will guide you through all requests of Health Authorities to arrange all required documents and to prepare for inspection of the Natural and Non-prescription Health Products Directorate (NNHPD) properly.
All Canadian drug establishments must hold, since January 1, 1998 a Drug Establishment Licence (DEL) to fabricate, package, label, distribute, import, wholesale, or test a drug. Medical Devices Establishment Licence (MDEL) is necessary for medical device entity to ensure compliance to the Medical Devices Regulations (MDR) and sections of the Food and Drugs Act (Act) applicable to medical devices.
We will support you to prepare all documents ready for submission to Health Authorities and review all preparatory steps to ensure successfully outcome upon Health Authorities’ inspection.
Atinza can walk you step-by-step to approach towards a successful eCTD submissions acceptance with Health Authorities, including, but not limited, to
Labeling of pharmaceutical drug products for human use should comply with the labeling requirements in current regulations, and is consistent with the Health Authorities’ guidance documents and policies that apply to pharmaceutical drug products for human use; and supports the safe and effective use of drug products by healthcare professionals, patients, and consumers. Label is also one of the most important and direct means of communicating product information between buyers and sellers.
We can review/arrange label/artwork and advise appropriate content to be placed on the label to ensure compliance with current regulations of Health Authorities.
We understand that your information is invaluable and confidential. We sign a non-disclosure agreement with you so that you can be assured that anything we discuss remains strictly confidential. Eventually some of the information will be part of the application process to Health Authorities but apart from that no other information will be disclosed to any other 3rd party.
We are dedicated is to achieve approval from Health Authorities for your qualified products in a timely manner. We will work closely with you to ensure all documentation are according to requirement of Health Authorities. We will support you all the way to alleviate regulatory burden but at the same time ensure optimum result for your products and your business.
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