A. MIS Services for Regulatory affairs

Lead Ventures offers regular MIS- regulatory services

  • Govt Policy decision
  • Latest Guidelines and Checkpoints
  • Case study of registered products
  • History of previously rejected cases
  • Registration Minutes, summery and history from beginning

CIBRC – Minutes of meeting
Analysis of Registered productsBased on

  • Companies
  • Product
  • Crop
  • Pest
  • Sample imported Special services
  • Composition and Impurity
  • Technical registered
  • Export Registration
  • Biological registration

Registrtion - Scrutinizing Capabilities

9(3) TI
9(3)TIM
9(3)FIM
9(3)FI
9(4)TIM

Our team of experts has the knowledge and experience to help you navigate the complex process of data generation for product registration.

B. Pesticide Registration

We take up all types of Registration dossier presentation

  • 9(3) TIM, FIM, FI, TI, New Source
  • 9(4) TIM
  • Export registration
  • Microbial Registration
  • Plant Quarantine approvals
  • Endorsement – Label claim, Factory address, Packaging etc
  • RTT submission
  • TIM - Technical Indigenous Manufacture
  • FIM - Formulation Indigenous Manufacture
  • TI - Technical Import
  • FI - Formulation Import
  • RTT - Sample import for Research Trial and Teating

Our approach – Pre scrutiny

At Lead Agri Venture, our approach begins with a comprehensive study of the data requirements for your product. We diligently analyze its attributes using both Indian and international data sources, and we finalize protocols in accordance with the relevant guidelines. With our team's expertise in regulatory matters, we can effectively assess any concerns that may arise.

We believe in providing our clients with a fair evaluation report, empowering them to make well-informed decisions.

Registration and Data Generation

Once we have established a clear strategy, we collaborate closely with GLP (Good Laboratory Practice) labs and maintain regular communication with the scientists of Contract Research Organizations (CROs). This ensures a smooth progression of your product through the registration process.

We meticulously examine Standard Operating Procedures (SOPs), study observations, available parameters, and checkpoints. After the completion of studies, we conduct a thorough scrutiny of the data before submitting it to the relevant authorities.

Bio-efficacy and Residue Studies

Our team of experts diligently examines your product, its unique selling proposition, and the regulatory requirements to develop protocols tailored to your specific needs.

We identify the most suitable research stations to ensure the generation of accurate and relevant data. Throughout the process, we maintain constant communication with scientists and other experts to ensure that you receive the best possible report in a timely manner..

Partner with Lead Agri Venture to benefit from our meticulous approach and expertise in regulatory processes. Contact us today to explore how our team can assist you in achieving your goals.

Sr Chemistry Studies
1 Chemical Composition
2 Purity and Physio Chemical Properties of
3 Active ingredient
4 Impurities
5 Adjuvant
6 Method of Analysis
7 Analytical Test Report (ATR) from GLP/NABL Lab
8 Characterization of active ingredient by UV-VIS, IR, MS and NMR spectra
9 Identification& Quantification of Impurities
10 Shelf-life studies
11 Storage Stability Studies
12 Establishment of Chemical Equivalence
13 Manufacturing process -
14 Chemical reactions with structural formulae and flow sheet diagram.
15 Effluent Treatment method with complete details
16 Methodology for residue estimation in BIS format.

Toxicological Studies

Study Sr. Parameters
Acute Study 1. Chemical Composition
2. Acute Dermal- Rat/Rabbit
3. Acute inhalation-Rat
4. Primary Skin Irritation-Rabbit
5. Acute Eye Irritation-Rabbit
6. Skin Sensitization Test–Guinea Pig
Sub Acute 7. Repeated dose range finding oral toxicity study (28 days) Rat
8. Repeated dose 90 days oral (Rat)
9. Repeated dose 90 days oral toxicity-Dog
10. Repeated dose dermal toxicity-Rat/Rabbit
11. Repeated dose inhalation toxicity
Neuro Toxicity 12. Acute Neuro-toxicity
13. Acute Neuro-toxicity
14. Repeated dose Neurotoxicity
15. Delayed Neurotoxicity
16. Developmental Neurotoxicity
Carcinogenetic 17. Combined carcinogenicity & chronic toxicity
18. Carcinogenicity-Mice
Development 19. Developmental toxicity study- Rat & Rabbit
20. Two generation reproduction toxicity in Rat
Miscellaneous 21. Mutagenicity
22. Pharmacokinetics and Metabolism in Rat.
23. Feeding study including Metabolism in Livestock
24. Pharmacokinetics and Metabolism in other mammals
25. Immunotoxicity study
Eco Toxicology 26. Acute Avian toxicity
27. Repeated dose Avian toxicity
28. Avian Reproduction toxicity
29. Acute toxicity to Fresh Water Fish
30. Acute Toxicity- Honey Bee (Oral & Contact)
31. Acute Toxicity- Earthworm

Bio-efficacy and Residue Studies

Sr Bio-efficacy
1 Bio-effectiveness
2 Phytotoxicity
3 Active ingredient
4 Effect on parasitoids and predators
5 Effect on beneficial soil micro-organisms
6 Translocation in Plants
7 Metabolism and Persistence Studies
8 Soil
9 Water
10 Plant
11 Compatibility studies
12 Residues studies
13 Cost/Benefit Ratio/ Rs/Ha return
16 Label and Leaflets

Packaging Studies

Sr Studies
1 Manner of labeling and Leaflet
2 Type of packaging
3 Manner of packaging
4 Specification for primary, Secondary and Transport packages
5 Container compatibility Test
6 Storage stability test (Shelf life Study)
7 Transport worthiness test