What we do

Product Registration

We work to understand your product then we can roadmap your compliance requirements. With years of expertise, we deliver holistic solutions: compliant, strategic, data‑validated, and scientifically sound solutions.

Janine Kelly

SACNASP Pr. Nat. Sci

Product

Registration

Our Process

UNDERSTAND YOUR PRODUCT

We need to understand your product, that helps us choose the right regulatory route.

Collect / generate all the data needed

Help get all the information and generate all the data you need.

Assess the data and prepare the submission

Making sure you get it right first time.

1

UNDERSTAND YOUR PRODUCT

  • Accurate identification of data requirements: Understanding the product’s identity, composition, and properties ensures the correct selection of required studies, as outlined in South Africa’s regulatory guidelines.

  • Ensuring compliance with safety, quality, and efficacy: Proper product knowledge supports development of the correct toxicology, efficacy, residue, and environmental studies needed for Act 36 registration.

  • Proper classification and product positioning: Product characteristics determine whether it is treated as a new active ingredient, generic, biopesticide, or remedy for organic agriculture.

  • Supporting complete and accurate dossier preparation: Understanding the formulation, analytical methods, and stability requirements ensures cohesive and compliant submissions.

  • Minimizing delays and avoiding data gaps: Clear product understanding prevents incomplete documentation and reduces the likelihood of regulatory queries or registration refusals.

2

COLLECT / GENERATE ALL THE DATA NEEDED

Professionally generated data ensures scientific credibility, supports a coherent dossier, and provides regulators with reliable evidence for decision‑making.

  • Ensures scientific credibility and regulatory acceptance through validated methodologies and robust study design.

  • Reduces the risk of data rejection or regulator queries by meeting guideline expectations from the start.

  • Supports a strong, coherent dossier narrative that aligns all evidence into a clear, defensible submission.

  • Reflects real‑world use conditions, strengthening relevance and reliability of study outcomes.

  • Identifies risks early, enabling adjustments and mitigation before dossier submission.

  • Improves efficiency and predictability of the evaluation process.

  • Strengthens market and stewardship confidence through high‑quality scientific evidence.

3

ASSESS THE DATA AND PREPARE THE SUBMISSION

  • Demonstrates scientific credibility: A polished dossier clearly presents how each claim is supported by reliable scientific evidence.

  • Meets all regulatory requirements: Ensures all chemistry, efficacy, toxicology, residue, and environmental data are properly included and aligned.

  • Reduces delays and minimises queries: Well‑organised information prevents avoidable regulator back‑and‑forth, speeding up review timelines.

  • Tells a clear scientific story: Data is connected logically to show how the product works, its benefits, and its safety profile.

  • Strengthens label accuracy and compliance: Ensures all label claims and directions are fully supported by data.

  • Builds confidence with regulators and the market: A strong dossier signals professionalism, stewardship, and commitment to safety.