The overall objective of the Caraka Clinical and Translational Sciences is to facilitate the transition of alternative medicine to modern medicine via disciplined, systematic scientific research of medicinal herbs and their use as medication. The standardization of alternative medicines involves both detailed chemical profiling as well as quality control research.
Through multidisciplinary Services, We will make every effort to understand and exploit the molecular effects of medicinal herbs, as to optimize potential therapeutic agents targeting cancer, diabetes, neurodegeneration, infectious, inflammatory and other rare diseases.. We have collaborations with the medical and scientific communities as well as government agencies
We at Caraka Clinical and Translational Sciences have a team of experienced, skilled and well-motivated management professionals dedicated to provide the most efficient, on time, cost effective, single window Quality services to our premium client base in India.
“Training for lack of potential investigators with fundamental knowledge of regulatory, ethical, GCP guidelines to conduct clinical trials”
“Training of ethics committees members with non-clinical backgrounds and to have a regular schedule of meetings”
Caraka Clinical & Translational Sciences Pvt Ltd being a Herbal/Nuraceutical Clinical Research Organization which provides services from Formulation Development to Product Development and Analysis to Clinical Trials along with Regulatory Services for Domestic as well as International markets.
We provide services for the natural products sold in the world market should be scientifically proven and been updated to the today’s customer knowledge and needs. We would cater to all such industry colleagues who seek to create scientifically driven products for the benefit of humanity and to eventually prove successful in the long run. Our services include
- Physio & Phyto Chemical Analysis
- Extraction and Isolation
- Microscopy, Chromatographic & Spectrophotometric Analysis
- Impurity Analysis
- Stability Study
2. CONSULTANCY SERVICES
- Formulation and Product development
- New Concept Development / New Project
- Standardization / Method development and validation
- Identification Of Herbs and Unknown Formulation
- Market Report
3. CLINICAL SERVICES
- Toxicity study/Animal study
- Clinical trails
4. Regulatory Services
- Literature review
- Drug master file
- Other documents
- Food Labeling Requirements & Regulatory Affairs
- Cosmetic Regulatory Affairs
- OTC Regulatory Affairs
5. Manufacturing Set-up
Site Licensing and Good Manufacturing Practices (cGMPs)
CARAKA CLINICAL AND TRANSLATIONAL SCIENCES PVT LTD as its expertise in setting up manufacturing units starting right from the beginning of selecting appropriate location and land, layout blueprints, turnkey projects, clean room set-up’s, machinery selection and installation, process set-up and validation until the commercial production. We build the facilities according to the USFDA-GMP, WHO-GMP and any other country specific GMP standards.
Our services in this area include:
- Territory and land selection for setting the manufacturing unit.
- Layout and blueprints development with approval from respective regulatory authority.
- Structural development.
- Turn-key and clean rooms project management.
- Machinery identification, selection and finalization.
- Setting up innovative and cost reducing manufacturing operations.
- Guidance in GMP certification, Manufacturing licenses, Halal, Kosher, NSF and ISO certifications.
- Development and implementation of a GMP compliant quality system.
- GMP audits.
- Preparation of Quality Assurance Reports.
- Preparation of Site License application dossiers.
- Site License Renewal applications.
- Site License annexations and amendments.
- Responding to government Information Request Notices (IRNs).
- Guidance in contract and customized manufacturing.
6. Scientific Writing
Our services in the area of scientific writing include a wide portfolio. We can create the following for you:
- Scientific publications and reviews in national and international scientific journals.
- Brochures for scientific and marketing purposes.
- Expert reports.
- Registration dossiers (CTD).
- Product brochures.
- Books and multimedia presentations.
7. Packaging & Designing
8. Marketing and Advertising
9. Product Distribution & Sales
10. KOL identification and Branding
11. ETHICS COMMITTIEE
WE HAVE S2J IEC, Holist Healthcare and Research Centre, Hyderabad is responsible for overseeing the studies conducted at the various AYUSH Hospitals not holding Ethics committee, in the local region.
Types of projects reviewed by IEC :
The IEC will review scientific and ethical aspects of All AYUSH and Allopathy research studies involving human participant( OPD based studies); sponsored by pharmaceutical companies, sponsored by Government of India / NGOs, studies in collaborations with international organisations/universities, all dissertation projects (postgraduate students :MD, MS, PhD, MSc,), research projects of undergraduate students carried out under guidance of teachers (e.g. Indian Council for Medical Research studentship or any other) and investigator initiated research studies which are self funded / funded by institutional funding bodies.
Working as Central Institutional Ethics Committee for all the AYUSH Clinics and Hospitals in the Local region
WE HAVE NETEORK OF STUDY SITES FOR CONDUCTING CLINICAL TRAILS GLOBALLY.
12. International business:
CARAKA CLINICAL AND TRANSLATIONAL SCIENCES PVT LTD helps you in achieving your gaols into the international business.
13. AYURVEDA MEDICAL DEVICES:
1. Mechanisms And Instrumentation
2. Design Innovation
For Ayurveda Medical Devices Innovation includes Product Design, Product Development, Concept Design, Engineering Design.