Biofact research Pvt. Ltd., is a contract research organization, started operations in 2019 with a thirst to provide regulatory compliant research and developmental services to Pharma, Biotech, Medical Devices, Food and Water and Agrochemical Industries in line with the all applicable current regulatory standards.
It is the first regulatory compliant CRO in the coastal region of Andhra Pradesh and offering comprehensive range of research and developmental services from product development to regulatory submission.
Regulatory compliant State of the art infrastructural facilities, Sophisticated equipment, Skilled & Experienced Scientists, well designed, Spacious and Qualified laboratory areas have carved biofact as the preferred destination for product quality testing and regulatory submission.
Understanding of customer requirements, design of customized procedures, continuous technical and regulatory support, fast turnaround times and maintaining confidentiality & Impartiality in testing, providing cost effective and efficient solutions have made biofact as customer centric contract research organization.
Robust quality management system is in place and backed by well-defined regulatory compliant standard operating procedures to ensure the identity, quality, safety and efficacy of the product.
The regulatory frame work has been established to support the customer regulatory submissions to all major regulatory agencies such as USFDA, TGA-Australia, Health Canada, WHO and CDSCO.
It is the laboratory implementing paper less data management and all the laboratory activities are performed, monitored and tracked through a validated online data management system. The data is maintained, accurately & consistently assured throughout its life cycle to ensure 21CFR part 11 compliance.
Sophisticated high-end equipment from world’s best manufacturers with latest technology, handled by qualified analysts, properly calibrated and well maintained to offer unsurpassed solutions to support the research and developmental requirements of the customer.
We are the integral part of the product development cycle and provide quality testing services for the evaluation of Drugs, pharmaceuticals, biologics, medical devices, radioactive residues, food, water and agrochemical products.
It is 21 CFR Part 210 & 211, CDSCO, PIC (S) and ISO 17025: 2017 compliant laboratory and offering end to end solutions for the services such as
- 1) Analytical Research Services
- 2) Medical Devices Testing Services
- 3) Food and Water Testing Services
- 4) Agrochemical Research Services
- 5) Radiological Testing Services
- 6) In-Vitro Toxicological Services
- 7) Microbiological Services
- 8) Mechanical Testing Services
- 9) Packaging Validation Services
We are technically sound, capable in providing specialty studies as per all major regulatory bodies and their requirements, specifically to the substance, product, material, container and closure.
In the view of all aforementioned, we are coming up as biggest regulatory compliant contract research organization with the objective of providing single solution for the product research and developmental requirements and preferred destination for quality testing with regulatory compliance.
QUALITY POLICY
Bio fact research Pvt. Ltd. is committed to achieving customer satisfaction by providing quality regulatory compliant research and developmental services to the Indigenous and global health care market players in compliance with internationally recognized regulatory standards and guidelines through stringent quality management system, robust regulatory frame work and effective implementation of GXP practices.
Mission
To be an integral part of product research and developmental cycle, through which a Safe and effective product for human use is discovered and developed in compliance with internationally recognized regulatory standards and guidelines.
Vision
To be a first referral contract research organization to render One Stop Solution for research and developmental services in compliance with global regulatory requirements to the clientele across the globe.