AZIDUS is a full-service clinical research organization catering to the technical needs of pharmaceutical and biotechnology industries for the conduct of randomized controlled trial, Bioavailability and Bioequivalence Studies, Clinical trials (Phase I-IV), Clinical Data Management, Pharmacovigilance and Regulatory submission to the Global drug regulatory agencies.
Azidus has expertise in wide range of highly specialized therapeutic areas such as oncology, cardiology, nephrology, urology, diabetology, dermatology, immunology, allergic disorders etc.,
Azidus will deliver the projects in quality beyond the expectations of the sponsors, on time and within proposed budget.
ACCREDITATIONS & APPROVALS
- ANVISA, Brazil
- Drug Controller General of India (DCGI)
- EMA
- First CRO in India approved by ISP Chile Regulatory
- First in India accredited by GLP – Poland
- Ministry of Health – UAE
- USFDA Inspected
- Approved by Ministry of Health – Turkey
- WHO (World Health Organisation)
- NABL (ISO 15189:2012) Accreditations for Diagnostic Laboratory
- CAP Accreditation for Diagnostic Laboratory
- National CPR Foundation Trained
- ISO Certifications, Rhineland
- ISO 9001:2008 for Quality Management Systems (QMS)
- ISO 27001:2005 for Information Security Management Systems (ISMS)
- ISO 10015:1999 for Training Standards
- ISO 14001:2004 for Environment Management System
- ISO 18001:2007 for OHSAS (Occupational Health Safety Assessments)
FACILITIES
Azidus started separate Pharmacovigilance division, Clinical Data Management and Regulatory division to provide end to end solutions in clinical research.
Clinical:
- Number of CPUs: 8
- Number of Beds: 480 (Expanding)
- Number of ICUS: 2
- Number of Beds in ICU: 14
Bioanalytical:
- LC-MS/MS – 24
- ICP-MS/MS- 3
- Number of Deep Freezers: 7 (ranging from -20ºC to -80ºC)
SERVICES
BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
Azidus has a dedicated volunteer mobilization team which does motivation and mobilization of the volunteers. More than 14000 volunteers including adult healthy males & females, post-menopausal females and geriatric volunteers are registered in the data bank.
Azidus can undertake the following studies.
- Single & multiple dose studies
- Fasting & Fed studies
- Food Effect studies
- PK PD studies
- Cross over and parallel studies
- Replicate studies
- Proof of concept studies
- Special population studies (postmenopausal & adult female studies and geriatric studies)
BA/BE studies are conducted in extremely controlled environment and all the clinical, bioanalytical and data management activities are strictly driven through SOPs.
The studies are conducted as per the ethical committee approved protocol, SOPs, current GCP, GLP standards and applicable regulatory requirements. The sponsors will be contacted and communicated during each stage of the study and updated about the proceedings of the study.
PHASE I – IV SERVICES
Azidus has experienced team of professionals to handle the all phases of drug development from Phase I to Phase IV clinical trials. The technical team can design and execute the phase trials at committed time as per the current International regulatory guidelines.
Azidus provides the following trial related activities:
- Study feasibility assessment
- Investigator and site selection
- Pre-study monitoring visit
- Site management activities
- Patient recruitment and retention activities
- Calculation of Maximum Recommended starting dose (MRSD) by considering NOAEL, LOAEL & MABEL
- Dose escalations adopting simple dose escalation, Modified Fibonacci method
- Preparation of Protocol
- Preparation of Investigator’s Brochure
- Preparation of Investigational Medicinal Product Dossiers
- Project Management
- Safety reporting
- Clinical Data management
- Study report preparation
Azidus has experienced CRAs, senior CRAs, Site co-ordinators in the team for clinical trial management. Azidus has Experienced and Regulatory audited Investigators in most of the therapeutic specialties including Cardiology, Diabetology, Neurology, Gastroenterology, Rheumatology, Endocrinology, Psychiatry, Dermatology, Oncology, etc., in the Investigator’s data base.
REGULATORY SERVICES FOR RANDOMIZED CONTROLLED TRIAL
- Preparation of regulatory dossiers for semi-regulated and regulated markets
- Preparation of dossiers in CTD format for Market Authorization in various countries
- Consultation, review and preparation of all modules of Common Technical Document for regulatory submission
- Liaison with drug regulatory agencies during submission
- Answering queries and preparation of Tabulated responses/Applicant’s Response Documents for RMS and CMS comments in Centralized (CP), Decentralized (DCP), Mutual Recognition (MRP) and National Submission (NP) procedures.
- Preparation of the regulatory dossier as per the requirements of the regulatory agencies.
- Preparation of clinical overviews, non-clinical overviews, clinical study reports, non-clinical study reports, summary of product characteristics and patient information leaflet.
- Following up with the regulatory agencies in case of decentralized/centralized/mutual/national procedures, and carrying out query clarification and query resolution in consultation with the sponsors.
BIOANALYTICAL SERVICES FOR RANDOMIZED CONTROLLED TRIAL
- Provide quality Bioanalytical services in rapid turnaround time.
- Development of protocols for Bioanalytical method development, method validation.
- Develop and validation of Bioanalytical methods far in advance.
- Method Development & Validation in various mediums like plasma (human, animals), whole blood, urine and Faeces.
- Partial development of Bioanalytical method validation transferred by Sponsor.
- Method transfer of drugs in biological matrix.
- Project management techniques to track and ensure that Bioanalytical projects are completed in the shortest time possible.
- Compliance with regulatory guidelines maintaining standards of excellence, efficiency & speed to meet the timelines
- Experienced Research Scientists Team dedicated to each LC-MS/MS.
- Bioanalytical Report Preparation and Review maintaining full compliance with regulatory requirements.
- Ability to run 240 samples per day per machine, amounting to 7200 samples per month, with highly skilled and experienced Bioanalytical professionals.
State of Art Bioanalytical Laboratory Equipment and Technology
- LC-MS/MS Agilent QQQ 6460\6490
- LC-MS/MS (WATERS XEVO TQ\TQS & Quttro Micro)
- LC-MS/MS Sciex API 4000
- Fully automated 3 HPLCs with PDA and Dual wave length detection techniques (WATERS 2695)
- -20ºC & -80ºC deep freezers
- Refrigerated centrifuge, milli Q water
- Nitrogen generator
- Microbalance
- SPE Solid phase extraction unit (Positive & Negative pressure)
- Other analytical equipment
CLINICAL DATA MANAGEMENT
- Designing of CRF using appropriate software
- Data management plan
- Data capture and database designing
- Independent double data entry verification and cross checking
- Complete data validation and generation of data validation report
- Quality Assurance processing by committed QA staff
- Comprehensive clinical data management services
AZIDUS LABORATORIES LIMITED
No.23rd School Road,
Rathinamangalam,
Behind Tagore Engg. College
(Via) Vandalur, Kelambakkam Road,
Chennai – 600 048.
Tamilnadu, INDIA
+91-44-27405244;
Email:
For Business Enquiries: bd@azidus.com
For Job Opportunities: recruit@azidus.com
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