bioneedsindia.com

Bioneeds, Bangalore which is a preclinical Contract Research Organization (CRO) also grow to be Government approved Drug Testing Laboratory (DTL), adds one more feather in its cap.

Bioneeds has been approved by Drug Controller in Form 37 of Drugs & Cosmetics Act, 1940 & Rules 1945 for carrying out tests for identity, purity, quality and strength on the following categories of Drugs/ item of Cosmetics ** and the Raw materials used in their manufacture on behalf of Licensees for Manufacture for sale of Drugs/Cosmetics (Reg No: KTK37/20/2009).

** Categories of Drugs/ Items of Cosmetic

1. Drugs requiring the use of animals for their tests ( mice, rats, rabbits & guinea pigs)
2. Cosmetics requiring the use of animals for their tests.

Reports of testing will be issued in Form 39 of Drugs & Cosmetics Act. All the tests will be carried out as per the guidelines with the spirit of OECD principles of Good Laboratory Practices (GLP).
Some of the tests to be conducted as per IP, BP, USP, Schedule Y etc

1. Abnormal toxicity
2. Specific toxicity
3. Pyrogen testing
4. Safety and potency tests
5. Biological assays
6. Potency assays
7. Eye irritation tests
8. Systemic toxicity studies

• a. Single dose toxicity
• b. Dose ranging study
• c. 14/28 days toxicity
• d. 90/180 days toxicity

9. Male fertility studies
10. Female reproduction & Development toxicity studies

• a. Female fertility study (Segment I)
• b. Teratogenicities study (Segment II)
• c. Perinatal study (Segment III)

11. Local toxicity studies

• a. Dermal toxicity study
• b. Vaginal toxicity study
• c. Rectal tolerance test
• d. Occular toxicity studies
• e. Inhalation toxicity studies

12. Allergenicity/ Hypersensitivity

• a. Guinea pig maximization test

13. Genotoxicity

• a. AMES
• b. Micronucleus

Feel free to call or mail us for any clarifications.
We look forward for an opportunity to serve your esteemed organization.
We cordially invite you to visit Bioneeds to appraise its capabilities and services.

Thanks & Regards,

Keshav Murthy S
BD & Project Management
-------------------------------------------------------
BIONEEDS PRECLINICAL SERVICES
Devarahosahally, Tumkur 15 km mile stone,
Nelamangala Taluk, Bangalore Rural
Karnataka, INDIA PIN:562 111

Phone: 0816-3208108 / 098450 95826 / 098444 57677
Fax : 0816-2255567
Email : This e-mail address is being protected from spambots. You need JavaScript enabled to view it