About Us
Overview
Our core business activity is to provide support to Pharmaceutical, Biotechnology, Animal Health and CRO industry in various areas of regulatory requirements involved in the development and registration of their range of products.
Through our strategically planned growth, we have built a company uniquely designed to meet the needs of our clients in a rapidly evolving and demanding product development environment. Our goal is to continue to develop and expand our business to ensure that we continue to exceed our clients' expectations.
We offer comprehensive laboratory and consultation services in the fields of bioavailability and bioequivalence studies, phase-I II and III Clinical Trials and pharmacovigillence and Post-Marketing Surveillance studies as well as Clinical Trial Data Management, toxicological studies, Statistical data management and medical writing, method development and validation and stability studies at various temperature and humidity conditions.
Commitment Statement
At Alpha Laboratories, we are committed to serving you and providing innovative and appropriate solutions to every task at every stage of your product's development. Our core expertise and operational abilities provide appropriate assistance to overcome the scientific and methodological challenges you face throughout the process of your product's development.
We are committed to exceed your expectations at all the times and will deploy all our resources and personnel to promptly meet your timelines and business objectives. We at Alpha Laboratories keep all our clients fully informed of all developments and be responsive to their needs through every step of development of your studies.
We at Alpha Laboratories are committed to observing and abiding by the highest ethical standards and principles in our industry and will represent your company with integrity. Throughout our relationship, we understand that our success is rooted in your success.
Our Team
Alpha Laboratories is managed professionally by persons with sound technical and business acumen.
1) Director & Principal Investigator:
Dr. B. V. Patil – MBBS, MD Pharmacology, PG Diploma in Clinical Research, having total experience of 10+ years
2) Director & Co-Investigator:
Dr. T. N. Rao - MBBS, MD Pharmacology, PG Diploma in Clinical Research, having total experience of 6+ years
3) Quality Assurance Manager:
Mr. S. D. Sen – M. Pharma and PG Diploma in Clinical Research and Quality Assurance having total experience of 5+ years
Quality
The Quality System established at Alpha Laboratories is the cumulative effects of premises, equipments, instruments, materials, services, documentation and personals involved directly and indirectly in the studies, projects and testing performed. The quality system and procedures are achieved by the commitment and team efforts of all the personals in every department and sections engaged in the clinical, bio-analytical, analytical and quality assurance.
The quality systems are implemented by operating within the framework of a formal Quality Assurance System based on current standards of ICH GCP and GLP practices. Continuous upgradation and training of the personals at our centre about the current guidelines of GCP and GLP are the vital improvement process.
As a means for proper implementation and follow up of the quality systems and procedures, all divisions and sections of Alpha Laboratories including Archive section undergo through an Internal Audit / Self Inspection process on six monthly basis by an internal auditors team consisting of multidisciplinary personals within the company.
Documentation And Confidentiality
On completion of a study, all study related raw data and reports are approved by Quality Assurance and a copy sent to the sponsor, then another copy is transferred in the Archive Section, which is completely segregated and dedicated for archive of documents only.The access to the Archive is highly restricted and controlled and maintained by the archivist.
The documents containing raw data, reports etc. related to a particular study are transferred promptly to the archive where they are protected against loss, alteration or theft.
The Department Head or Principal Investigator submits a statement of accountability of data and files to the archivist at the time of submission. Once placed in the archive section, the responsibility for the safe keeping of those documents lies with the archivist and management. There is a well-defined SOP for the retention of raw data and for controlling and documenting retrieval and loan from the Archive section.