|Norwich Pharma Services|
|Over its 127-year history, Norwich has built a reputation for dependable product supply and established an unparalleled history of regulatory compliance. Each day, the Norwich team strives to deliver uncommon value and be the first choice of customers for pharmaceutical contract services. Norwich offers a full range of commercial scale solid dose manufacturing and packaging capabilities.|
|A Reputation for Dependable Product Supply|
Product delivery and quality assurance are business critical functions that Norwich performs in compliance with industry and regulatory requirements. Our Lean Six Sigma supply chain employs SAP as an operating platform. Norwich quality systems provide validation, change control, production support, documentation control and other cGMP services to both the plant and to our customers. Norwich has a proven record of successfully meeting compliance requirements for regulatory agencies worldwide, including FDA, EMA and ANVISA. Reference is http://www.norwichpharma.com/Manufacturing/OperationalExcellence/ without the table at the bottom.
|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:
• Intermediate potent compounds handling
• DEA scheduled compounds
• Solvent processing
• 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
• 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.