Do you need cost-effective offshore clinical and manufacturing solutions?

With our unique USA-India Connect business model, you can rely on cost-effective solutions without compromising the Quality or Compliance. High quality/compliance is assured by working with only FDA experienced clinical sites, a FDA inspected & audited BA/BE facility, and an OECD GLP certified laboratory. These BA/BE facilities have conducted several such BA/BE, patient PK/PD and BE with Clinical Trial End Point studies for US-FDA submission. Furthermore, clinical trials proof-of-concept and pivotal clinical trial studies are conducted through CROs with relevant experience conducting such trials in India for US/EU regulatory agencies.

We have done an extensive due-diligence on vendors in India, and have short-listed clinical CROs, CMOs with good regulatory, and GxP compliance track-record. These pre-identified vendors network assures best pricing and highest quality for its clients' clinical projects. The low cost development option through our USA-India Connect services saves clients hundreds of thousands of R&D dollars. Besides, our designated technical project manager in the USA will work closely with your study team to oversee & manage following studies in India;

• Bioavailability / Bioequivalence - BA/BE Studies
• Pharmacokinetics / Pharmacodynamics – PK/PD Studies
• BE with Clinical End Point Studies
• Drug Substance, (Re-) Formulation, and Drug Product Manufacturing
• Clinical Trials – Phase Ia and IIa (proof-of-concept), IIb, and III Studies

• Central air-conditioned Clinical Pharmacology Unit (CPU) facility with dedicated area for screening, counseling, phlebotomy, access-controlled pharmacy, recreation & dining room with state-of-the-are monitoring
• CPUs with intensive care unit (ICU) beds with defibrillators, ventiltors, cardiac monitors, oxygen supply as well as access to multiple-speciality hospitals to handle serious emergencies.
• Experienced and well trained in ICH GCP guidelines.
• Database of over 4000-5000 volunteers including female volunteers and special population..
• Access to patient population with many therapeutic area including CNS disorder, diabetes etc
• Studies conducted at these centers are audited and approved by various international regulatory agencies including US FDA, EMEA and WHO

• State-of-the-art animal facility that includes housing specific pathogen free rodents, with GLP-compliant analytical / bioanalytical capabilities.
• Good Laboratory Practices (GLP) accredited facility by Government of India and EU regulatory agencies including Government of Netherlands
• AAALAC, OECD-GLP-compliant with exposure to USA and EU Regulatory Agencies.
• Access to a variety of rodents and non-rodents for IND-enabled Toxicology studies
• Large pool of experienced scientists with a significant percentage with Ph.D degree, independent QA department reporting directly to senior management.
• Cost-efficient with quick turn around time
• Extensive experience conducting, BA, BE, patient PK/PD and BE with Clinical Trial End Point studies.