Clinical Testing and Regulatory Services
Outsource Your Clinical Testing
To reduce cost, many pharmaceutical companies are outsourcing their clinical testing to India to reduce cost. Trials in India can save roughly 60% to the pharmaceutical and biopharmaceutical companies.
We collaborate with a couple of state-of-the-art clinical testing laboratories in India that has the knowledge, deep experience, manpower, and sophisticated tools and facilities to provide excellent services for all of your regulatory needs - whether it is pre-clinical or regulatory services or clinical trials.
Clinical Trial Services
The trials are conducted in compliance with the ICH-GCP guidelines coordinated with utmost precision and every detail is carefully monitored to enable acceptance of various regulatory agencies across the world.
The services include:
- Clinical Protocol Development
- Case Report Form Design
- Electronic Data Capture (EDC)
- Investigators Identification & Qualification
- Monitoring & Project Management
- Clinical Site Management
- Data Management & Statistical Analysis
- Medical Writing & Regulatory Submission
- Auditing & Quality Assurance
Pre-clinical Services
Our partners provides non-animal pre-clinical research and testing for evaluating toxicity and efficacy. They have developed various in-vitro methods for claim substantiation of products to determine the efficacy and safety of products by pre-clinical assays.
The team has extensive experience in in-vitro assay validation studies conducted worldwide, as well as in serving the testing needs of diverse industrial clients. Their familiarity with an array of different assay systems and product lines gives them the knowledge and expertise to determine the optimum assay for specific test materials and applications. They are experienced in performing in-vitro procedures in compliance with Good Laboratory Practice (GLP).
Some of representative studies include:
- Anti-Oxidant Study and DPPH Radical Scavenging Activity, ORAC, HORAC, ROS assay
- Anti-Inflammatory, Anti-Aging Studies
- Tanning and Skin-lightening Models, and Related Studies
- Melanin Inhibition Using Mouse Melanoma Cell Line
Tanning models - Assays of Various Microorganism Activities
- Wound Healing Assays
- Trace analysis, dissolution studies, stability studies
..and many other assays
Regulatory Services
Our partner's regulatory affairs team understands the importance of the highest quality regulatory submissions. They will work with you to Plan, Prepare & Complete global or local submissions and will Communicate, Interact and Liaise with regulatory agencies to ensure approval on time.
We can help you with:
- Developing and presenting strategies and tactics needed to ensure regulatory compliance and maintain marketing authorizations.
- Preparations of documents for IND, NDA, ANDA, CTD submissions and also for supporting registrations of the new entities with MHRA, MCC, USFDA, TGA, Malaysia, European Union etc in concurrence with the regulations promulgated by a whole range of agencies like the Environmental Protection Agency, Federal Trade Commission, Occupational Safety & Health Administration and Drug Enforcement Administration.
- Utilizations of different approaches for latest regulatory practices through peer interactions
Contact Us
We and our partners would love to discuss your requirements in more detail. Do contact us today with your requirements.