NAVIGATING YOUR COMPLIANCE
We help manufacturers, importers and distributors assess their regulatory pathway, prepare dossiers and follow up registration projects in their target market.
Two areas of regulatory expertise
Regulatory strategy, active substance and formulated product dossiers, scientific evidence and submission support in each target country.
Explore plant protection registration
Fertilizers, biostimulants and growing media: product classification, technical dossiers and labelling adapted to the target market.
Explore fertilizer registrationFertilizers and growing media
Tell us your target country to define the applicable pathway. Our bilingual knowledge base below covers Morocco, with a comparison of the French framework.
The applicable route depends on composition, intended use and claims. Certification, authorization and exemption procedures must not be treated as interchangeable.
Explore Morocco fertilizer resources
For manufacturers, importers & distributors
Whether your company is based in Morocco, Europe, China, the United States or the Middle East, start with your product and target market. Explore our services in English, French or Chinese.
Tell us where your company is based and where you intend to market your products. We distinguish your country of origin from the country whose registration requirements apply.
We review the documentation available for the product and identify missing information, national requirements and the next steps for dossier preparation.
The scope of support is defined around your product portfolio, the target markets and the work required. Submission and follow-up depend on the applicable procedure.
Understanding registration
Registration confirms that the product is effective and that its risks are acceptable under the proposed conditions of use.
The assessment examines human and animal health, residues, environmental fate, non-target organisms, efficacy, selectivity and regulatory compliance.
Registration tools
Select an approach suited to available resources, evidence and the regulatory framework of the target country.
Open this section02From pre-registration through review, every step supports a structured assessment of the application.
Open this section03Define the studies needed to demonstrate product efficacy and safety through internationally accepted protocols.
Open this section04Apply procedures and models suited to each scientific component of the dossier.
Open this section05Define effective, practical and communicable measures to reduce health and environmental risks.
Open this section06Connect risks, values, alternatives and management measures to reach a regulatory decision.
Open this section07Verify that the product meets general protection goals and applicable scientific and legislative criteria.
Open this section08Compare available options when a product is highly hazardous or its risks are difficult to manage.
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About us
We transform complex regulatory frameworks into clear, actionable pathways from strategy to final decision.
Registration expertise
Choose support for your product, your target market and the current stage of your dossier.
Regulatory support for plant protection product registration in Morocco and North Africa: strategy, dossier review, scientific data, GEP trials, submission and follow-up.
Open this servicePreparation and quality control of ONSSA registration dossiers: administrative documents, formulated product, active substance, scientific studies, efficacy and labelling.
Open this serviceGap analysis for plant protection product registration dossiers: compliance, missing studies, inconsistencies, priorities and an actionable dossier plan.
Open this servicePreparation of the active-substance section in Morocco: identity, properties, analytical methods, toxicology, residues, environment, ecotoxicology and classification.
Open this serviceCoordination of GEP trials in Morocco: protocol, field setup, application, scoring, efficacy, selectivity, statistics and study reporting.
Open this serviceMulti-country plant protection product registration strategy for Morocco, Algeria and Tunisia: master dossier, national gaps, adaptations and coordinated follow-up.
Open this serviceOur services
We build and format dossiers in line with national guidance, including REF/HP/05/14 in Morocco. The formulated-product package covers identity, physicochemical and technical properties, toxicology, analytical methods, application data, efficacy, selectivity, classification and labelling. The active-substance package covers identity, properties, analytical methods, toxicology, metabolism, residues, environmental fate, ecotoxicology and classification.
We manage renewals, regulatory surveillance, use and portfolio extensions, multi-brand strategies, dose and PHI changes, revised conditions of use, ownership transfers and supplier updates.
We perform completeness checks, organize submission, prepare responses to additional-information requests, update documentation and manage administrative follow-up through final validation and publication.
We coordinate with accredited GEP/GLP organizations for sample importation, field application, data collection, statistical analysis and extrapolation. We cover efficacy and selectivity trials, residue studies for MRL and PHI validation, and physicochemical, toxicological and ecotoxicological studies involving bees, birds, aquatic organisms and other non-target species.
Our process
Assess company status, product nature, data-protection profile, target uses and countries.
Determine the correct category, applicable chapter and evidence pathway in each target country.
Collect, structure and validate identity, physicochemistry, analytical methods, toxicology, residues, environmental fate, ecotoxicology and efficacy data.
Submit to the competent authority and manage additional information, amendments and follow-up through the final decision.
Where we operate
ONSSA · Law No. 34-18 and applicable technical references.
MADR · Executive Decree No. 95-405 and commission submission route.
DGPCQPA · Decree 2010-72 and national dossier requirements.
How to assess study quality, critical effects and uncertainty when selecting toxicological reference values.
Read the article →Regulatory Services by MCARE supports plant protection product and fertilizer registration projects through regulatory scoping, dossier preparation, scientific review and authority follow-up.
Explore our regulatory servicesOur services support manufacturers, importers and distributors preparing projects for Morocco and North Africa. Tell us your target market, product type and available documentation so that the team can assess your request.
Discuss your projectOur country pages cover Morocco, Algeria and Tunisia. Each market has its own procedure and evidence requirements; the applicable route is checked for the individual project.
Explore country guidance
