Lead Ventures offers regular MIS- regulatory services
CIBRC – Minutes of meeting
Analysis of Registered productsBased on
Registrtion - Scrutinizing Capabilities
Our team of experts has the knowledge and experience to help you navigate the complex process of data generation for product registration.
We take up all types of Registration dossier presentation
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.
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.
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. |
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 |
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 |
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 |