Scalable FDA, EPA and ATF compliant cGMP processing and production facility handles projects of all sizes, including wet chemistry, analytical testing, quality testing, stability studies and new product development in our cGLP
All Products are further verified by an independent third party ISO:9001 cGLP
laboratory to ensure consistency in quality, purity, potency, and absence of potential toxins.
FDA, cGMP, cGLP
, NACD DEA and other reassuring letters We follow the NACD's "responsible distribution and product stewardship" codes in every phase of chemical packaging, storage handling, transportation and disposal.
laboratory services include sample preparation know-how, genomic profiling applications, biomarker discovery capabilities, assay design and validation, CLIA-based clinical testing, bioinformatic analysis, a high level of regulatory proficiency, and project management expertise.
Testing methods confirm to ISO 9001-2008 and cGLP
Through its development services in ADME and CMC areas, as well as cGLP
and cGMP testing, the company brings value to its clients by rapidly providing high quality project planning and execution through its experienced staff and management team.
With the implementation and validation of this software and qualification of its instrumentation, Arista intends to be fully compliant with 21 CFR Part 11 and 21 CFR Part 58 guidelines thus ensuring adherence to cGLP
The company is capable of pilot scale production, and their analytical laboratory operates under cGMP & cGLP
It enjoys an excellent reputation with regulatory authorities and has its own cGLP
approved facility for bio-equivalence and Phase I pharmacokinetic studies with capacity to undertake up to 14 studies per year.
laboratory services include project management expertise, sample preparation know-how, genomic profiling applications, biomarker discovery capabilities, assay design and validation, CLIA-based clinical testing, bioinformatic analysis, and a high level of regulatory proficiency.
Asuragen is empowered with a high level of scientific expertise and assay development along with a well developed business infrastructure, cGLP
testing services and an established cGMP manufacturing facility that allows it to span the spectrum of discovery, testing, production and commercialization.
services are suitable for clinical research studies, pharmacogenomics, and biomarker discovery.