Byrne Dairy

IRIX Pharmaceuticals, Inc. is a privately held company engaged in the generation of process technology for new and existing drugs.

IRIX offers the full capability of supplying API’s and complex pharma intermediates from pre-clinical stages, through all phases of clinical trials, registration/validation batches, launch and ongoing commercial quantities.

Formed to provide the Pharmaceutical Industry with a low-cost alternative for bringing new drugs to market rapidly, IRIX operates three sites for Process R&D and Clinical through Commercial cGMP production of API’s. Process R&D and early stage clinical supply for API’s is based in Florence, South Carolina. Late-stage clinical supply and commercial production is located in Greenville, South Carolina.

IRIX ensures compliance with all regulatory and quality requirements. Both the Greenville and Florence site were visited by the FDA in 2008 and 2009, respectively, with no 483s issued for either site.

IRIX supports new drug development in all functions necessary to bring a pharmaceutical candidate from discovery to market. IRIX provides seamless technology transfers both to/from Clients and internally for API syntheses.

The demonstrated expertise of the IRIX staff and the company’s emphasis on quality, economics, and timely delivery make it a choice CRMO (Contract Resources and Manufacturing Organization) for innovative pharmaceutical clients desiring to bring new drugs to the market rapidly.

Operating as an extension of the internal resources, IRIX offers sharp process solutions for an accelerated time to market at a very competitive cost.

Red Bag Solutions (RBS) is a company that provides environmentally friendly, cost-saving solutions for on-site treatment of medical waste and bio-hazardous waste. RBS is a manufacturing and waste management services company that provides waste treatment and disposal technologies to convert medical, clinical and infectious waste into sterilized, safe and unrecognizable material that can be recycled or placed in a municipal landfill.

RBS offers a comprehensive array of programs and services to meet the complex needs of any organization that generates medical and bio-hazardous waste, including hospitals and healthcare facilities, pharmaceutical and biotechnology companies, and diagnostic and research laboratories.

Red Bag Solutions can help a facility save money on the processing and disposal of Regulated Medical Waste

Reduce the environmental impact of your RMW in the landfill by grinding and sterilizing the waste to reduce the volume up to 90% and weight by up to 30%.

Utilize our patented technology to render the waste unrecognizable and fully HIPAA compliant

Reduce the facility's carbon footprint by utilizing fewer trucks to transport the waste to the landfill.

Improve pandemic preparedness - onsite processing is available to handle sudden increases in waste due to a pandemic or weather event.

Red Bag Solutions offers attractive acquisition options to facilities that want to begin utilizing this technology.

Let us create a fully customized plan that addresses the specific needs and desires of your facility.

To learn more or connect with a Red Bag Solutions professional in your area,please visit www.redbag.com

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.

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

Pharmaron is a contract research organization (CRO).

Services:
* Synthetic, medicinal and analytical chemistry services
* Biology services
* DMPK services
* Pharmacology services
* Drug safety assessment services
* Radiochemistry and isotopically labelled metabolism services
* Chemical & pharmaceutical development services
* Clinical development services

www.pharmaron.com

CRO - Contract Research Organization
Library Synthesis
CADD
Bioorganic Chemistry
Discovery Process Chemistry
Radiolabelled Chemical Synthesis
ChemInformatics
in vitro Biology
in vitro Screening
Structural Biology
in vivo Pharmacology
Animal Disease Models
ex vivo Pharmacology
Biomarkers
in vitro ADME
in vivo PK
PKPD
QA
Regulatory Affairs
Discovery Biologics
Process Chemistry
API Manufacturing
Material Science
Formulation Development
Drug Product Manufacturing
Toxicology
Safety Pharmacology
Genetic Toxicology
DART
Pathology
Immunotoxicity
Bioanalytical
14C / Carbon-14 Radiosynthesis
3H / Tritium Radiosynthesis
QWBA
mARG
Clinical AME
Mass Balance
Metabolite Profiling
Microdosing Phase 0
Absolute Bioavailability
DDI
First-in-Human (FIH)
Thorough QT(TQT)
Ethnobridging

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.