Allied Services
AnaCipher CRO
AnaCipher CRO based in Hyderabad, India, is a state-of-the-art clinical research facility spread over an area of 40,000 sq. ft. and is staffed by experienced professionals. It is equipped with a 146-bed facility, monitoring stations, phlebotomy stations, 8-bed ICU, state-of-the-art analytical lab and has capabilities for e-CTD submission.
Core Strengths
Clinical Services (BA/BE, Phase I/II, taste evaluation, drug-drug interaction/pharmacokinetic studies)
Bio-Analytical Services
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Database of more than 20,000 + healthy human volunteers for BA/BE studies
NABL accredited clinical laboratory.
The CRO has successfully completed more than 750 studies for pharmaceutical companies across the globe and has been successfully audited by various regulatory authorities, USFDA, UK-MHRA, CDSCO, NABL (Diagnostic Laboratory), WHO, EMA-Netherlands & France, NPRA-Malaysia, ANAMED-Chile, MoH-Oman, Thai-FDA, GCC-DR & Projects approved by TPD-Canada, NPRA-Malaysia, GCC, China, South Africa & other ROW countries
Indoco Analytical Solutions
Indoco provides Analytical Services through 'Indoco Analytical Solutions', utilizing state-of-the-art infrastructure and highly experienced team of scientists. Indoco Analytical Solutions is a USFDA Approved cGMP Laboratory.
Services offered:
Genotoxic Evaluation
Nitrosamine Analysis
NAP Test
Purge Factor Analysis
Extractables & Leachables
Metal Analysis as per ICH Q3D
Impurity Standards
Polymorphism Studies
Particle Size Analysis
Crystallography
Thermal Analysis
Analytical Method Development & Validation
Impurity Isolation / Characterization / Qualification
Partition Coefficient and Dissociation Constant
www.indocoanalyticalsolutions.com
Global Stability Centre
Our Global Stability Centre is designed to support innovator and generic pharmaceutical industries globally. The Centre, located in Waluj - India, is equipped to assist pharmaceutical companies evaluate the shelf life, storage conditions and overall stability of products to comply with global regulatory guidelines.
With a focus on quality, reliability, and regulatory compliance, the Stability Centre serves as a trusted partner in the development and commercialization of pharmaceutical products.
Key Functions:
Stability Study Design & Execution: For new drug development, ongoing process validation, and post-approval changes.Accelerated and Long-term Stability Testing: To assess product behaviour under different climatic zones.
Photostability Studies: In accordance with ICH Q1B.
Regulatory Support: Provides critical data for dossier submissions (CTD/ANDA/NDA) and life-cycle management.
The Gloal Stability Centre is staffed with experienced scientists and analysts trained in GMP and GLP practices. The team ensures that all processes are well-documented and audited regularly for compliance, contributing significantly to product quality assurance and regulatory approval.
Infrastrucure:
High Performance Liquid Chromatograph
Gas Chromatograph
UV-visible Spectrophotometer
Karl Fischer
Dissolution Apparatus
Walk-in Stability Chambers
Microbiology Laboratory
Analytical Laboratory
Xtend Industrial Designers & Engineers Pvt. Ltd.
Xtend Industrial Designers & Engineers Pvt. Ltd., is a subsidiary of Indoco Remedies Ltd. It offers engineering and consulting services for all phases of project development, from project design to product validation. Xtend has been providing these services to Pharmaceutical Formulations & API industry for the past 15 years and has completed several facilities which are internationally approved.
Services offered:
Architectural Design
Lighting
Mechanical & Utility Engineering
Project & Construction Management
Electrical
Control System
Piping
Structural Design
Data Transfer System
Process Engineering