Pre-registration services
The cheapest place to fix a registration problem is before any money has been spent. Our pre-registration work establishes whether the product can be registered at all, on what route, with what claim, and at what cost.
- Schedule check, banned and restricted list check, and review status of the active
- Search of already-registered products to establish whether a Section 9(4) route exists
- Route and category selection: 9(3B), 9(3) or 9(4); TI, FI, TIM or FIM
- Written data gap analysis with costed study plan and realistic timeline
- Dossier pre-screening for files prepared elsewhere
Product registration
- Technical grade registration for import (TI) and indigenous manufacture (TIM)
- Formulation registration for import (FI) and indigenous manufacture (FIM)
- Provisional registration under Section 9(3B)
- New product registration under Section 9(3), including new molecules and new label claims
- Me-too registration under Section 9(4)
- Combination and ready-mix formulations
- Registration for export only, and import of technical for export
- Bio-pesticide registration for microbial, botanical and biochemical products
Permits and approvals
- Import permits and renewals, extension of validity, addition of manufacturer or shipper
- Change of source name in an existing import permit
- Import permits for non-insecticidal use, including boric acid, non-boric acid and biocides
- Permit for Research, Test and Trial (RTT) of unregistered products
- Free sale certificates for export markets
Post-registration and lifecycle
- Enhancement of shelf life and change of packaging material or pack size
- Addition of crops, pests or diseases to an approved label claim
- Endorsement for change of factory or office address and change of company name
- Transfer of certificates of registration between entities
- Label and leaflet revision in line with new notifications
- Regulatory monitoring and alerts on notifications affecting your portfolio
Data generation and study management
We do not run laboratories, and we think you should be sceptical of consultants who claim to do everything in-house. What we do is choose the right institution for each study, review the protocol before work starts, monitor conduct, and check the report against the requirement it is meant to satisfy.
| Study group | Typical components |
|---|---|
| Chemistry | Five-batch analysis, active content, impurity profile, physico-chemical properties, method of analysis, specification |
| Toxicology | Acute oral, dermal and inhalation; skin and eye irritation; sensitisation; sub-acute and chronic studies; mutagenicity and teratogenicity where required |
| Ecotoxicology | Avian, fish, honeybee and earthworm toxicity; other non-target organisms as applicable |
| Bio-efficacy | Multi-location, multi-season field trials on the claimed crop-pest combinations, with phytotoxicity observations |
| Residue | Residue, persistence, metabolism and waiting period determination |
| Storage | Accelerated and real-time shelf-life studies, packaging compatibility, transport simulation |
Administrative and allied support
Where clients are setting up in India for the first time, we also assist with company incorporation, office establishment, and appointment of an Indian agent or nominee registration holder for foreign manufacturers, on clearly documented contractual terms.