TECHLIGAMENT LIFE CARE GROUP Kalyan West, Thane, Maharashtra

1. Bio-equivalence –Clinical Studies: Independent Bioequivalence studies Monitoring services, Selection of CRO, Site, Bio-study outsource
2. Global Comparator / RLD/ Innovator Products Sourcing from USA, UK, CANADA, France, Brazil, Japan, and Australia or Buy Back-RLD Expiry from USA.
3. Medical Writing Services:
e-CTD Dossier
PSUR Preparation,
Clinical and Nonclinical Module 2, 4, 5
Pharmacovigilance report,
Risk Management Plan, Abstract,
Manuscript Writing and Literature
4. Full-Text Literature (Medical and Non-Medical Journals Articles) @200 + GST and Translation Services
5. Contract Research Manufacturing and Marketing and Distribution Services
Selection of CMO as per the requirement of the client like Regulatory approvals ( USFDA, Europe, TGA ROW and ANVISA approvals)
Third-Party Manufacturing finished Products and API
We will coordination for Marketing, Distribution Support all your products in Major Countries like USA, UK, EU, ROW countries like Nigeria, Ghana, Kenya, Rwanda, Uganda, Myanmar, Philippines, Cambodia, UAE, Saudi Arabia, Cameroon, Angola, Niger, Tanzania, Mozambique, Liberia, Madagascar, Burkina Faso, Ethiopia, Togo, Mali, Malawi, Burundi, Botswana, South Africa, Mongolia, Sri Lanka, Bangladesh, Malaysia, Vietnam, Uzbekistan, Tajikistan, Azerbaijan, Kyrgyzstan, Turkmenistan, Armenia, China, Hungary, Iran, Ukraine, Thailand, Romania, Kazakhstan, Indonesia, Georgia, Colombia, Egypt, Yemen, Syria, Russia, Zimbabwe.
Handled Dosage Form: Tablets, Capsules, Creams, Ointments, Solutions, Injections, Syrup, Powder, and Aerosols.
Accreditation Certificate: WHO Approved, USFDA, UK, WHO-GMP, MCC, ANVISA, and EU or PICS and ROW countries approved Plants
6. Regulatory Services like:
DCGI - NOC (No Objection Certificate) for Bio-equivalence studies
DCGI - NOC (No Objection Certificate) for Clinical Trials
DCGI - NOC (No Objection Certificate) for Medical Devices
Import License Application for Drugs, Raw Materials Like API, Medical Devices
Ethics Committee Registration
Drug Registration and Export License application
Narcotic Department NOC, Export License activities from Narcotics Department Gwalior
7. Analytical Services USFDA approved facility in the USA and India
Extractables & Leachables
In-Vitro Permeation Testing (IVPT)
In-Vitro Release Testing (IVRT
Stability Studies
Cascade Impaction
Genotoxic impurities and quantification
Carcinogenic impurities identification and quantification
Reverse Engineering Works
Impurities Identification
RLD- Ingredient Analysis