Department of Veterans Affairs, Office of Inspector General

Our goal is to assist you to properly plan and execute your clinical strategy to assure early FDA approval and expedite your product to market.

Clinstat Consulting was founded in 1999 by Patricia Hamilton, RN, MS.

Patricia is a clinical expert with over 25 years experience. She is a Registered Nurse and holds a Master's Degree in Business Management. She has had extensive senior level technical and management experience delivering clinical research plans and studies on time and within budget for Fortune 500 global corporations as well as for small companies and start-ups. She has set up and managed clinical departments from the ground level and has hands on experience in all phases of developing a clinical/regulatory strategy, securing investigators, site selection, protocol development, site monitoring, generation of final reports and writing FDA submissions. Patricia and her staff are well suited to guide start-up companies or assist established firms with any or all your clinical needs.

TGA BioServices, an Absorption Systems'​ Company, is an FDA inspected contract research laboratory providing the Pharmaceutical, Biotechnology and Research communities a comprehensive range of laboratory services in support of research and clinical studies. We offer the client a complete package of customized testing systems utilized in preclinical through Phase IV studies, all in compliance with cGLP and cGMP requirements.

We specialize in the development and validation of immunoassay systems for the detection of target molecules, antibody responses and quantification in total compliance with QA and cGMP standards.

TGA BioServices also offers in vivo mouse studies for the optimization of vaccine immunization schedules, dosing, adjuvant screening, immunogenicity testing for the release and stability of bulk and finished clinical product, as well as complete antibody development programs. Furthermore, we offer Guinea pig dermal sensitization testing for the identification of contact allergens. All programs are supervised by an in-house Institutional Animal Care and Use Committee (IACUC), while the facility is USDA registered and AAALAC accredited.

Other services provided include FACScan cell labeling studies, tissue culture, endotoxin testing, basic R&D activities, sample storage, specimen collection kits with on-site training, data management, protocol generation (SOP), database/statistical analysis and consultation. TGA BioServices has the credentials your project is searching for.

Addgene is a nonprofit plasmid repository located in Watertown, Massachusetts. Addgene’s mission is to accelerate research and discovery by improving access to useful research materials and information. Addgene facilitates the sharing of high-quality scientific materials, research reproducibility, and open science by archiving and distributing DNA-based research reagents and associated data to scientists worldwide. Addgene’s repository contains over 70,000 plasmids, including special collections on CRISPR, fluorescent proteins, chemogenetics, optogenetics, and viral plasmids. All plasmids in Addgene’s repository were deposited by your scientific colleagues from around the world. There is no cost for scientists to deposit plasmids, which saves time and money associated with shipping plasmids themselves. All plasmids are fully sequenced for validation and sequencing data is openly available. Addgene also provides ready-to-use AAV and lentiviral preparations of commonly requested plasmids as a service to scientists. Addgene offers free online educational resources and protocols about molecular biology topics such as common vector backbones, cloning, CRISPR, AAV and lentivirus production, and science careers. These resources include the Addgene blog, eBooks, guides, videos, and a podcast series.

Founded in 1997, Alkemist Labs is a pioneer in botanical identity testing with expanded capabilities in phytochemical potency analysis. We are passionate about full method transparency, personalized technical support, and unrivaled customer service. With our expertise in this very specialized testing niche, we can help you in all aspects of ensuring that you know exactly what is in your products. Alkemist Labs helps companies achieve and maintain quality products and cGMP compliance.

In addition to services such as identity verification by HPTLC and microscopy and potency testing by HPLC and GC, we now offer Next-Generation DNA Sequencing as a new powerful tool available for speciation in plant-based products. Because this technology has often been misapplied and standard methods are not yet developed, Alkemist Labs uses this platform alongside more established and accepted testing methods in order to accelerate understanding of this technology and help make it one of the useful testing tools for dietary supplements and ingredients.

Alkemist Lab’s mission is to bring transparency to all areas of natural products industry testing includes education tools designed to demystify testing and help companies obtain accurate results to support regulatory compliance and illustrate their quality commitment to consumers.

In addition to our testing services, Alkemist also offers a full catalog of reference materials to be used by your in-house laboratory. These critical tools for botanical identity verification, including the Alkemist Labs complete line of Composite Reference Botanicals (CRBs), AHP-Verified Botanical Reference Materials (BRMs), all easily purchased through the Alkemist e-commerce section of the website.

We are hiring! We are looking for talented Scientists, Chemists, Analysts, Technicians and Quality Assurance personnel. For more information, visit www.alkemist.com/job-openings/

Altogen Labs is a biology CRO company providing GLP preclinical research services, tox studies for IND applications, RNAi and gene silencing services, xenograft testing services (100+ tumorigenic cell lines), in vivo siRNA delivery and biodistribution, development of stable cell lines, and many more.

Altogen Labs is a GLP compliant laboratory that provides preclinical research and biotechnology contract research services (CRO) to pharma, biotechnology companies, universities, and cancer research centers worldwide. Our services include pharmacology and toxicology assays (IC50), cell banking, generation of stable cell lines, RNAi gene silencing and other in vitro services. Altogen Labs provides following in vivo services for efficacy studies in the drug discovery phase: rodent xenograft models, teratoma formation and analysis services, cancer disease animal models, in vivo siRNA delivery and tissue targeting, pharmacokinetics (PK) and pharmacodynamics (PD) services, immune response and biomarker analysis.

Altogen Labs recently developed an `active bioremediation`​ process based on an approach using the most potent oil-degrading bacteria found at multiple oil spill sites in Texas. This technology allows remediation of large amounts of hydrocarbon-contaminated liquids or soil. The genomes of both microorganisms were recently sequenced, which revealed that both strains were previously unreported in the literature. Altogen Labs filed bioremeddiation patent application in 6/2012.