PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USA
BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multi-step purification for both traditional and bio-pharmaceutical applications. Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions. All of our manufacturing processes are fully validated. Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources.
Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled. We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.
GMP Product Categories:
• Bulk, GMP Biological Buffers
• Active & functional Excipients
• GMP Process Chemicals and Bulk GMP Solution Solutions
Custom GMP Services Include:
• Purification of Key Ingredients
• Full GMP Product Development
• Small Molecule Custom Synthesis
• API Development & Manufacturing
• Custom GMP Compounded Solvents & Solutions
Comprehensive Quality and Regulatory Program
• FDA Registered and Inspected
• Document Support - DMF Submissions
• Global GMP Requirements – US, IPEC, ICH Q7
Située sur la rive-sud de Montréal, Laboratoires Confab est spécialisée dans le développement et la fabrication de produits pharmaceutiques (CDMO). Des investissements majeurs sont en cours, dont un agrandissement de l’usine, afin de supporter la réalisation de ses projets en R&D et la commercialisation de nouvelles formes posologique novatrices en développement. L’entreprise évolue dans des contextes réglementaires canadiens et américains. Pour en connaître davantage sur notre entreprise : http://www.confab.com/french/
Confab specializes in the development and manufacturing of non-sterile pharmaceutical drugs (CDMO). The plant, located on the south shore of Montreal, is growing with major expansion investments underway to support an increasing volume of R&D projects as well as pioneering new dosage forms. The company complies with both Canadian and US regulatory requirements. To know more about Confab Laboratories please visit the website at http://www.confab.com/
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.
Since 1997, KABS has offered a broad range of product development services to the bio-pharmaceutical industry, worldwide. We support pharmaceutical development programs from initial discovery to phase III. Our cGMP compliant services include strategic planning, pre-clinical development, analytical testing, formulation development, manufacturing of prototypes and clinical supplies, distribution of clinical supplies to clinical sites and CMC aspects of regulatory affairs.
We help our clients advance their topical and transdermal drug programs all the way from product concept assessment through to first regulatory filing, or with one or more stages in between. Our parent company, Encube Ethicals, is a global leader in topical contract manufacturing services, operating the world’s largest single-site manufacturing site for such products. Together, Tioga Research and Encube Ethicals can support our clients from early formulation product innovation through to full-scale commercial manufacturing.
Clients regularly seek the support of Tioga Research for one or more of:
• Analytical method development & verification
• Pre-formulation (solubilities, compatibilities etc.)
• Formulation re-engineering (for delivery improvements and freedom to operate)
• Formulation innovation (for optimal performance & patentability)
• Skin delivery & permeation screening
• Broad-based screening of formulations using proprietary high throughput experimentation platforms (such as INSIGHT™, STORM™, TORNADO™ and SPLASH™)
• in vitro release testing (“IVRT”) & in vitro permeation testing (“IVPT”) under GLP conditions for release and bioequivalence support
• Formulation optimization
• Stability assessments
• Product esthetics assessment (sensory panels)
• Skin safety studies (employing third-party CRO)
• Patent application support
• Technology transfer
#TiogaResearch helps progress client programs intended for the spectrum of regulatory paths: #topical505b1, #transdermal505b1, #topical505b2, #transdermal505b2, 505(j) (or ANDA), 510(k) and PMA. We are particularly adept at creating high-performing formulations that have a robust basis for composition of matter patentability.
#TiogaResearch supports personal care and skin care companies by creating and deploying new measurement platforms, by information mining and text data aggregation, by innovating excipient packages, and by completing measurements of skin deposition, delivery and permeation.