|Synchronized outsourced solutions|
|Norwich Synchronized Outsourced Solutions, offering complete services for a product's entire lifespan: from development, clinical research, and formulation to commercialization and manufacturing.|
|Comprehensive product development capabilities|
Companies seeking product development and technical services can turn to Norwich for engineering solutions, formulation, analytical method development and validation, process optimization and scalable manufacturing.
Product Development & Technical Services staff, equipment and facilities are dedicated to serve all of your manufacturing and packaging needs for small to mid-scale development, clinical supply and stability programs.
The Norwich team works with both immediate and modified release products, and has expertise in a number of unique dosage forms, including:
• Tablets and capsules
• Liquid filled hard gelatin capsules
• ODT tablets
• Laser drilled tablets
• Extruded and spheronized beads
• Wurster coated beads and granules
• Mini-tablets filled into capsules
• Aqueous and solvent tablet coating
Norwich development and pilot scale facilities are located within 8,000 square feet of DEA approved, solvent and potent compound capable space that also contains two laboratories dedicated to support R&D and GMP development projects.
These facilities are strategically designed and equipped to provide solid dose manufacturing technologies in both R&D and GMP environments. The facilities, equipment and technology mirror Norwich commercial capabilities, allowing direct transfer from analytical to quality control, and enabling a fast track to trade production.
|Cutting-edge commercial manufacturing technology|
Norwich employs cutting-edge technologies to satisfy a wide spectrum of project demands, including products that are difficult to manufacture.
Norwich's commercial production capabilities include:
• Potent compounds handling
• DEA scheduled compounds
• Dry blending
• Wet and dry granulation
• Fluid bed granulation and Wurster coating
• Tabletting, including bi-layer tabs
• Encapsulation and capsule banding
• Tablet coating and printing
• Solvent coating
Norwich packaging suites are self-contained and include the following capabilities:
• Solid dose
• Bottle and blister packaging technology
• Slat and slatless fillers
|Clinical services and capabilities|
|Clinical Research Capabilities|
Clinical expertise is the foundation of our business. Norwich staff have been conducting clinical studies for more than 20 years, including 2,000+ biostudies that have resulted in successful regulatory submissions to FDA, EMA and numerous local agencies.
• Multiple hospital-based clinic locations
• Pharmacokinetics studies in healthy volunteers
• Drug metabolism studies
• Dose proportionality studies
• Multiple dose studies
• Experience in multiple dosage forms
|Bioanalytical and Laboratory Services|
Norwich Clinical Services provides quantitative measurements of active drug and/or metabolite in biological matrices. Our method development team is committed to developing methods with the lowest • LOQs and quick turnaround time.
• Method development and validation
• Sample analysis
• LC-MS/MS-API 4000 UPLC
• HPLC & LC-MS/MS analysis of drug and metabolites in biological fluids
Norwich Clinical Services offers comprehensive, low-cost pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
• Signal detection analysis and risk mitigation programs
• Oracle AERS 24x7 call center monitoring
• FDA, EMA and CEE country submissions via eCTD utilizing eCentral
• Axway Synchrony Gateway for E2B exchange
• Large volume data migration capability
• Preparation of ICSRs and PSURs
• QPPV support
• PV database support
Norwich pharmacovigilance activities are conducted in compliance with the 2012 EU Pharmacovigiance Legislation and has completed numerous filings into the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
All Norwich pharmacovigilance services are fully compliant with GCP, GLP and 21 CFR part 11.