N2 Compliance Ltd.

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Product Registration

What we do

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Plant Health

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Pest Management

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Compliance Consulting

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About Us

Founded in 2012, N2 Compliance Ltd. is a client-centric regulatory compliance consulting company providing expertise to Canadian and International clients for plant health, crop protection and pest control products.

With more than 65 years of combined regulatory compliance experience, we work to simplify the Canadian regulatory system and obtain the required market approvals for our clients.

We truly love what do! Let us show you how we can make sense of the Canadian product registration and compliance process for your organization.

Caroline Dykstra Nielsen

Caroline brings more than 33 years' experience in the agriculture, pest management and new product development sectors. Caroline's technical background includes: field research trials; report/data preparation; GLP trial development and implementation; project and program management; SOP development; data analysis & auditing; and chemical/materials laboratory management.

Shawn Nielsen

Shawn has more than 32 years' experience in new product development applications, specializing in regulatory affairs and product compliance. Shawn's technical background includes: product development & design; project and program management; data analytics; product testing & validation; compliance strategy design; compliance auditing; standards development; and quality assurance/quality control.

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Plant Health

The Canadian Food Inspection Agency (CFIA) is responsible for the regulation of plant health products in Canada, including: plant pests and invasive species, trade, fertilizers, soil and soil-related matter, grains and field crops, seeds, cannabis, forestry and horticulture. This also entails the rapidly growing "biostimulants" product grouping.

With respect to plant health, the CFIA is responsible for the administration and enforcement of the following Acts and regulations

Fertilizers and supplements are regulated under the Fertilizers Act and associated regulations;
The importation and handling of invertebrates and micro-organisms (insects, mites, millipedes, earthworms, snails & slugs, bacteria, fungi, viruses, phytoplasmas, nematodes) are regulated under the Plant Protection Act and associated regulations; and
Seeds sold in, imported into and exported from Canada must meet established standards for quality and must be labelled so that they are appropriately represented in the marketplace, and for most agricultural crop varieties, must be registered prior to sale in Canada, and are regulated under the Seeds Act and associated regulations.

N2 provides consultation and expert guidance on:

Pre-market applications
Fertilizer/supplement registrations/amendments/renewals
Import permits
Crop variety registrations
Plants with novel traits registrations

In addition, N2 Compliance provides technical services in:

Organic product & specialty product registrations.
Documentation: standard operating procedures; SDS development; product specifications; test protocols; label development; manuals & packaging; and processes/procedures.
Data analytics: research & analysis; data input & evaluation; technical GAP analysis; risk assessments.

Pest Management

Crop protection, pest control and plant growth regulator (PGR) products, regardless of whether they are biological or synthetic, are regulated in Canada through Health Canada's Pest Management Regulatory Agency (PMRA) under the Pest Control Products Act and associated regulations.

The PMRA utilizes a stringent science based evaluation process to assess any potential risks associated with the product(s), including: a detailed electronic submission package for registration review; a 15-year re-evaluation cycle to ensure current scientific standards are met on all registered products; special reviews for specific product chemistries/formulations as required; and the promotion of sustainable use of crop protection, pest control and plant growth regulator products.

N2 Compliance provides consultation and expert guidance on:

Pre-submission consultation package preparation & submission
Value summary (DACO Part 10 / M10)
Scientific rationales
Label and use patterns
Registration package preparation
Management of submissions (Agent)
E-filing (ePRS) submission
Research authorizations / notifications
Renewals
Re-evaluations

In addition, N2 Compliance provides technical services in:

Organic product & specialty product registrations.
Documentation: standard operating procedures; SDS development; product specifications; test protocols; label development; manuals & packaging; and processes/procedures.
Data analytics: research & analysis; data input & evaluation; technical GAP analysis; risk assessments.

Canadian Registration Expertise

Plant Health & Pest Management

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Plant Health

Pest Management