Company Overview
Norwich Clinical Services is a global Contract Research Organization (CRO) providing Clinical Research, Bioanalytical, Pharmacovigilance and Training Services.
The CRO is headquartered in Bangalore, INDIA and the leadership team have deep insight, knowledge and experience in the conduct of Bioavailability/Bioequivalence (BABE) studies, Clinical Research - Phase I-IV, Pharmacovigilance and Training services.
Our facilities have been inspected by most global regulatory agencies such as FDA, WHO, ANVISA, MOH Turkey, EMA, NPRA, MHRA and CDSCO India.
All our services are conducted in strict conformity with the latest GCP, GLP and 21 CFR (part 11) and all other applicable guidances.
We have state–of-the-art facilities, and exceptional expertise to conduct Phase I, II and III studies, bioavailability and bioequivalence studies, pharmacokinetic studies in patients & healthy subjects, drug metabolism studies, dose proportionality studies, multiple dose studies and clinical developmental programs. Our team has considerable experience in various dosage forms including parenterals, suspensions, topical preparations and delayed release formulations.
We combine comprehensive services and exceptional customer focus to offer a complete range of Clinical, Bioanalytical, Pharmacovigilance and Training Services.
Norwich Clinical Services is a Lotus Pharmaceuticals Company.
MISSION STATEMENT
Norwich Clinical Services is committed to maximizing customer satisfaction and strives to achieve the goal of excellence, through a continuous improvement of our processes, systems and services, in delivering high quality projects meeting regulatory requirements in full compliance with GCP, GLP and all applicable good practices in a timely manner.
All levels of the organization are dedicated to the process of exceeding customer requirements
Milestones
year 2010
- Started Operations with Pharmacovigilance (PV) Services
year 2011
- Started Bioanalytical Services
- Successful audit of PV Service remotely by FDA at Sponsor site
- Operations merger of LCRA and NCS
year 2012
- Started Clinical Services
- Conducted First FDA and WHO study
- Facility Approval from ANVISA (Brazil)
year 2013
- Conducted first ANVISA Study
- Facility Approval from MoH Turkey
year 2014
- Conducted studies for FDA, EU, ANVISA and WHO submissions
- Second Successful PV Service audited remotely by FDA at Sponsor site
- Successful WHO audit
year 2015
- Successful completion of an FDA and EMA inspections of our clinical and bioanalytical operations
- Successful audit by ANVISA
year 2016
- Successful Audit of USFDA of our BABE clinical facility
year 2017
- Third succesful USFDA Audit of our PV services
- Succesful USFDA Audit of our Bioanalytical unit
- Start of our Clinical Facility at Koramangala
year 2018
- Successful audit of WHO of our BABE facility