• To become a preferred drug development partner to pharmaceutical organizations through innovation and quality services

Mission Statement

• Implementing newer technologies
• Continuous learning and development
• Meeting international regulatory standards
• Customer satisfaction
• Shortest turnaround time

• Innospecs Bioresearch private Limited is a fast growing contract research laboratory offers complete drug development service, from design to final results evaluation to global pharmaceutical companies.

• We provide services in study execution, project handling, site, data management and results.

• Phase I to Phase IV clinical studies

• Clinical end point determination

• Patient based PK studies

• Establishing proof of concept

• Clinical studies for Nutraceutical, Herbal, Cosmetic products to establish safety and efficacy.

Site Capabilities

• Innospecs Bioresearch has collaboration with more than 10 leading corporate hospitals in South India.

• Among the tie up clinical research centers, two of the hospitals have more than 1500 beds with multispecialty patients care.

• Hospitals sites are expertise in specialties like, Cardiovasular, Endocrinology, Hepatology, Neurology, Pulmonology, Pediatric medicine, Reproductive medicine, Oncology, Rheumatology, Immunology, Radiology, Opthalmology, Urology and Psychiatry.

Innospecs Bioresearch has expertise in conducting clinical trials in key therapeutic areas like:

• Oncology

• Endocrinology

• Dermatology

• Orthopedics

• Gynecology

• Gastroenterology

• Analgesics & Anti-inflammatory

• Innospecs bioanalytical facility is spread over 2500 square feet area. Founder has expertise in development and validation of various challenging drug molecules.

• More than 600 bioanalytical methods were developed and validated for various drug and metabolites.

• Facility equipped with dedicated isolated space for storage of biological samples at -70°C and -20°C

• Separate wet lab space with refrigerated centrifuge, Vibramax shaker, Fume hood, Nitrogen evaporator and Vortex machine for sample preparation

• Facility is equipped with mono chromatic lights to handle light sensitive drugs. Dedicated electronic microbalance is available to weigh analytical standards

• Laboratory is equipped with Sciex API-4000 instrument with Shimadzu Prominence HPLC system integrated with Analyst software

• Dedicated archival space available with metal cabinets and fire proof light system. Hard copy data soft copy DVD are arranged and maintained by dedicated Archivist

• Expertise in the analysis of biological samples for separation and estimation of Chiral isomers (R & S), Cis and Trans isomers (E & Z)

• Protocol for clinical study

• Clinical study report writing

• Clinical study summary and eCTD modules

• Publication and peer-review articles

• Regulatory writing and safety communications

• Dataset preparation in accordance to USFDA guideline

• Innospecs bioresearch has a dedicated, independent quality assurance department, who reports to the director.

• Quality assurance ensures the strict implementation of cGMP, GLP & GCP

• Qualified auditor verifies the on-line process, internal quality audits (system, facility and safety)

• Handle customer suggestion time to time for improvement of quality

• Regularly trains the staff on quality system

• Evaluate the Pharmacokinetic and Statistical parameters for the trial product in accordance to protocol and regulatory guidelines.

• Prepares data management plan and adhere to the requirement

• Generates Electronic file (SAS transport file)

• Prepares CDISC in accordance to USFDA guideline

• Enters the data with high accuracy

• Analytical method development

• Analytical method validation

• Analytical method transfer from R&D labs to Manufacturing plant/another lab

• Accelerated stability studies

• Phytochemical Research – Extraction, Isolation and Characterization.

• Pharmaceutical raw materials

• Chemical intermediates

• Nutraceuticals

• Natural drug product and purified plant product extract is tested using equipments viz: HPLC,GC-MS, UV-SPEC, ICP-MS, LC-MS/MS

• Ion Chromatography and immune-sorbant assays

• OECD

• Schedule Y

• Pharmacopoeia (IP/BP/USP/JP)

• ICH-FDA

• US-EPA

• EMA

• CIB

• Redbook

• CDSCO

• Acute /Single Dose Toxicity in Rodents and Non-Rodents

• Repeated Dose Toxicity in Rodents and Non-Rodents 14, 28, 90 and 180 Days)

• Dermal Irritation/ Corrosion-Rabbits

• Eye Irritation/ Corrosion –Rabbits

• Skin Sensitization – Guinea Pigs

• Chronic / Carcinogenicity – Rodents

• Reproduction and Developmental Toxicity

• Male fertility

• Teratogenicity/Prenatal Development Toxicity

• Bacterial Reverse Mutation Test (AMES)

• In Vitro Chromosome Aberration Test

• In Vitro Cytotoxicity Test using MTT, XTT and Neutral Red Uptake

• Comet Assay

• Cytotoxicity

• Sensitization

• Irritation or intracutaneous reactivity

• Acute Systemic Toxicity

• Subchronic Toxicity

• Genotoxicity

• Implantation

• Hemocompatibilty

• Quantification of Hormone

• Immunogenicity Assay

• Drugs and Metabolites quantification

• Anti-hypertensive Activity (2K/1C Renal Hypertension)

• Isoproterenol Induced Myocardial Necrosis

• DOCA- Salt induced Hypertension

• Diuretic Activity

• Diabetes Model: STZ or High Fat Diet

• Anti-Obesity Activity

• Atherosclerosis – Cholesterol Diet Induced

• Hyperlipidemia – Triton Induced

• U87MG – Human Glioblastoma Cell lines Induced – Antiglioma Model

• HCT – 15 Induced Colon Cancer

• MCF7 Induced Breast Cancer

• ALS (Amyotrophic Lateral Sclerosis)

• Dementia – Scopolamine Induced

• Parkinsonism – MPTP Model

• Stroke – Middle Cerebral Artery Occlusion and Reperfusion

• Wound Healing Models

• Paw Edema Test

• Collagenase Induced Model

• Formalin Test

• Adjuvant Induced Arthritis

• Mazes (Y Maze, Plus Maze, Radial Maze)

• Open Filed Test

• Beam Walk

• Rota rod

• Custom Protocol for all chemical induced disease model