regulatory

Comprehensive Submission Preparation & Publishing Services

Regulatory Affairs Services

Atinza provides regulatory assessment, strategy, and guidance for the clients to customize to theirs unique needs and budgets. Our comprehensive Submission Preparation & Publishing Services includes, but not limited, to:

Clinical Trial Applications
New drug and biologic submissions (NDS, SNDS, ANDS)
Abbreviated New Drug Submissions
Supplemental submissions
Drug Identification Number Applications
Prescription (Rx) to over-the-counter (OTC) switch submissions
Agency liaison
Regulatory CMC consulting services
Strategic Development Consulting

PHARMACEUTICAL PRODUCT LICENSING

Drugs are authorized for sale in Canada once they have successfully gone through the drug review process. This process is the means by which a drug application is reviewed by scientists in the Health Products and Food Branch (HPFB) of Health Canada, and on occasion, outside experts, to assess the safety, efficacy and quality of a drug.

Atinza can manage the submission process in Canada until achieving Notice of Compliance or NOC including post-approval changes. We advise firms on drug establishment licensing options, so that upon product approval, firms can quickly and compliantly bring products to market.Read More

TECHNICAL LABEL REVIEW

Atinza will work closely with clients to ensure label of pharmaceutical products will comply strictly with the labeling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations, the Controlled Drugs and Substances Act, and its related Regulations including the Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations and the Benzodiazepines and Other Targeted Substances Regulations. We will also advise clients relating requirements in other relevant Health Canada guidelines, policies and technical documents.

DRUG APPROVAL PROCESS IN CANADA

Atinza will work with clients as early as the CTA or Clinical Trial stage. We provide ongoing submission expertise through to NDS/NDA drug approval in Canada. We file New Drug Submissions or New Drug Applications with Health Canada on behalf of the clients.

Once application has been submitted, we will follow Health Canada’s evaluation process and inform clients for any inquiry from Health Canada. We assist clients to attend to Health Canada’s requirement in an efficient manner to avoid delay for approval process.

After application is approved by Health Canada, we will send to clients Notice of Compliance or NOC including post-approval changes.Read More

DRUG ESTABLISHMENT LICENCE

A Drug Establishment Licence (DEL) is a licence issued to a person in Canada allowing them to conduct licensable activities in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations.

A person who wishes to fabricate, package / label, test, import, distribute, or wholesale in Canada a finished dosage drug or bulk process intermediate or wishes to fabricate, package / label, test or import in Canada an active pharmaceutical ingredient is required to hold a DEL.

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Drug Establishment Good Manufacturing Practices

Prior to submission of a Drug Establishment Licence Application to Health Canada for the activities of wholesaling, Importation and Distribution of pharmaceutical products, it is required that your establishment meets the minimum requirements of GMP Compliance in place prior to an inspection.

We will assist clients to prepare Drug Establishment Good Manufacturing Practices – Pre-Application Package for submission to Health Canada.

Manufacturers & Warehouses

All other entities that involves with the product should also provide documents evidencing their compliance with GMP standards. These entities include, but not limited to, foreign manufacturers, warehouses. Atinza will work with these facilities to ensure proper documents are arranged as they are part of the application for importer’s site licence with Health Canada.

Preparing your Establishment for a First Inspection

Atinza will assist clients to ensure your facility meets requirements for Establishment Licence. We will review and advise clients to prepare proper Drug Establishment Licence Application in order for Health Canada determines that your site is ready for an inspection.

An assessment of the client’s readiness for inspection could be evaluated by means of a phone interview from Health Canada.