Norwich Contract Pharmaceutical Development & Manufacturing

Norwich Company Overview

Norwich is a recognized leader in full service contract pharmaceutical development and manufacturing. As a single-source provider, Norwich offers customers solutions with the highest level of quality and reliability from product development to scale-up and commercial manufacturing through clinical services.

With a focus on improving patient outcomes, you can depend on Norwich - a reliable partner for all stages of your product’s lifecycle.

• Bioanalytical Services
• Production Development and Technical Services
• Clinical Research
• Pilot Scale Manufacturing
• Commercial Manufacturing
• Packaging and Distribution
• Ongoing Pharmacovigilance

We deliver what you ask for, when you ask for it:

• Operational Excellence
  Over its 125-year history, Norwich has built a reputation for dependable product supply and established an unparalleled history of regulatory compliance. Using Lean Six Sigma principles, Norwich is continually improving operational systems and quality controls to create greater flexibility and responsiveness for each customer’s product.

• Product Development and Technical Services
  Norwich offers comprehensive product development capabilities to provide customers with R&D, GMP pilot scale manufacturing, analytical development and validation, and testing services.

  The Norwich team has expertise with unique dosage forms, including:

  • Liquid filled hard gelatin capsules
  • ODT tablets
  • Laser drilled tablets
  • Extruded and spheronized beads
  • Wurster coated beads and granules
  • Mini-tablets filled into capsule
  • Tablet-in-tablet compression
  • Solvent and aqueous processing
• Commercial Manufacturing and Packaging
  A full range of manufacturing and packaging capabilities and resources includes non-potent and intermediate potency tablet and capsule solid dose forms, as well as semi-solid and liquid dose forms.

• Fast-Track Tech Transfer
  Experience the Norwich Advantage for commercial manufacturing and packaging with a fast-tracked tech transfer that will guarantee reliable product supply. On-site technical services allow direct transfer from quality control to trade production.

  To request a Fast-Track Tech Transfer, call 1.888.674.7979, or email info@norwichpharma.com.

• 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 coatin
• Norwich packaging suites are self-contained and include the following capabilities:
  • Solid dose
  • Bottle and blister packaging technology
  • Slat and slatless fillers
• Services

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

Pharmacovigilance Services
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

All Norwich clinical solutions are conducted in strict conformity with GCP, GLP and CFR part 11 compliance.

Technology
Norwich Clinical Services is focused to provide technology-driven solutions that facilitate clinical research programs and provide our clients with absolute privacy and data quality assurance. Clinical data management includes archival procedures that guarantee data security with compliance for international regulatory requirements.

Global Therapeutic Expertise
Norwich Clinical Services invests in capabilities and teams to help customers succeed and their patients live better. Our expertise is focused on targeted therapeutic areas:

• Cardiovascular
• CNS
• Dermatology
• Endocrinology
• Infectious Disease
• Nutritional Health
• Oncology
• Respiratory

Locations
Norwich Clinical Services operates clinical solution centers in North America, Europe and Asia to provide a full range of contract research programs, including:

• Norwich, New York
• Bucharest, Romania
• Reykjavik, Iceland
• Moscow, Russia
• Bangalore, India

Focus on your patients. Focus on You.

With a focus on improving patient outcomes, Norwich is a reliable partner for all stages of the product lifecycle.

Norwich is a recognized leader in full-service contract pharmaceutical development and manufacturing. As a single-source provider, Norwich offers customers solutions with the highest level of quality and reliability from product development to scale-up and commercial manufacturing through clinical services.

Over its 125-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.

Our Values

Customer Focus: Simply put, we find answers to customer challenges. We listen. We find solutions. We are forward looking, anticipating each customer's needs and discovering new opportunities to meet them. Mutual respect and understanding enables us to work together and create solutions for the benefit of customers and patients.

Innovation: We are energetic and creative, always seeking to improve. We learn from our successes and failures. We encourage and support new ideas. And at the end of the day, we deliver what you ask for, when you ask for it.

	Norwich Pharmaceuticals Company Brochure Norwich Pharmaceuticals is a full-service outsourcing provider of Rx and OTC pharmaceutical products with 120 years of experience in the production, packaging, quality assurance and distribution of solid dose, semisolid and liquid pharmaceuticals.
	Norwich Primary Equipment List Primary Equipment List for Norwich Pharmaceuticals. Norwich is a leader in solid dose pharmaceutical production. We offer expertise, comprehensive manufacturing and packaging support from clinical trial through scale-up and to commercial launch.
	Norwich Clinical Services Brochure Norwich Clinical Services is a global contract research organization for the pharmaceutical and biotech industries. Dedicated Norwich program management will guide your program from the initial stages of development through study-end reconciliation with specific focus on budget efficiency and schedule adherence. With a focus on improving outcomes for patients, Norwich partners with you to deliver visionary solutions with the highest level of quality and reliability.
	Supply Chain Video By engaging a multi-level, cross-functional supply chain process, hear why Norwich is able to always put the customers' needs first.
	Research and Development Video Listen to how R&D at Norwich is streamlined to ensure the most forward-thinking solutions for its customers.
	Pilot Scale Video Understand why Norwich can seamlessly provide solutions in smaller scale, with reduced materials, faster and at a lower-cost.
	About Norwich Video Passionate partner, innovative thinker, and customer-focused manufacturer – discover the Norwich of today and tomorrow.
	Norwich History Video Uncover Norwich from its earliest days to today.
	Commercial Manufacturing Video Learn more about Norwich's wide range of commercial manufacturing. By focusing on innovation, Norwich ensures clients stay in the forefront.