Manoj Kumar's Contact Details

Manoj Kumar's Company Details

Insignia Clinical Services

New Delhi, Delhi, India • 11 Employees
Pharmaceuticals

Insignia Clinical Services (ICS) is a leading Indian Contract Research Organization, headquartered in New Delhi, India; Currently servicing clients from Pharmaceutical, Biotechnology, Medical Device & In-Vitro Diagnostics, Cosmetics, Food & Health Supplements, Agrochemicals (Insecticides / Pesticides). ICS offers customized, innovative, timely managed and goal oriented solutions for requirements related to Regulatory Affairs, Clinical Trials (Phase I-IV), Non-Clinical Studies, Medical Writing & Pharmacovigilance.ICS delivers a complete spectrum of services for clinical trial and regulatory consulting throughout the product lifecycle from concept to commercialisation & beyond. ICS goes a mile ahead to support its clients by offering various Ancillary Services such as government affairs & liaisoning, distributor identification & qualification, regulatory intelligence, strategic out-licensing/in-licensing opportunities, which gives them strategic advantage to prevail over the competition.Our unique solutions are scalable & best fit for your different project requirements, whether you are a Multinational Company, Indian Manufacturer or Importer.REGULATORY AFFAIRS• REGULATORY STRATEGY & PROJECT PLANNING• REGULATORY SUBMISSION• IN-COUNTRY REPRESENTATION• REGULATORY INTELLIGENCENON- CLINICAL SERVICES• NON-CLINICAL STUDIES• PERMITTED DAILY EXPOSURE• TOXICOLOGICAL RISK ASSESSMENTCLINICAL SERVICES• BIOSTATISTICS AND STATISTICAL PROGRAMMING• CLINICAL ANALYTICS• CLINICAL DATA MANAGEMENT• CLINICAL TECHNOLOGY• SITE SELECTION, INVESTIGATOR RECRUITMENT & PATIENT SERVICES• PROJECT MANAGEMENT• QUALITY ASSURANCEMEDICAL WRITING• REGULATORY WRITING• CLINICAL & NON-CLINICAL STUDY WRITING• PHARMACOVIGILANCEANCILLARY SERVICES• GOVERNMENT LIAISONING• DISTRIBUTOR IDENTIFICATION & QUALIFICATION• MERGER & ACQUISITION