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NSF: What Does Your Company QMS Look Like? Where Does Senior Management Fit In?
NSF was asked by top management to review the range and extent of GxP quality systems in place and make recommendations for a single company-wide QMS suitable for its modern business model and meeting all anticipated regulatory requirements.
Contract Research & Services > Contract Services > Case Studies
NSF: Does Your Pharmaceutical Quality System Improve Your Competitive Edge?
There are some companies who believe that their Pharmaceutical Quality System (PQS) exists purely for regulatory compliance. We think this attitude is outdated and plainly wrong. At NSF, we believe that your PQS has only one purpose: to improve your competitive edge by guaranteeing the manufacture of high quality medicines at the lowest possible cost. We have worked in partnership with many of our clients to help them improve their PQS and their competitive edge. The following results give you a flavor of what can be achieved and how.
Contract Research & Services > Contract Services > Case Studies
Tech Talk: CHANGING GMP BEHAVIORS with NSF
| By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.
Contract Research & Services > Contract Services > White Papers
NSF: Making Pharmaceuticals
NSF International will be exhibiting at Making Pharmaceuticals, the only dedicated free to attend event in the UK that addresses the detailed and complex issues associated with sourcing, manufacturing, outsourcing and delivering of consistent pharmaceutical products to the market.
Contract Research & Services > Contract Services > Press Releases
PTC Therapeutics agrees to buy Marathon's DMD drug for $140m
PTC Therapeutics has agreed to acquire all rights to Emflaza (deflazacort) from Marathon Pharmaceuticals.
Contract Research & Services > Contract Services > News
NSF: KPIs and the Head of Corporate Quality: KPIs Are Essential for a Successful Product Release
| By NSF Health Sciences Pharma Biotech PBR
What are your views on KPIs? Essential or a necessary evil? “They are absolutely essential, providing they are good! I remember during a regulatory inspection I was asked every QP’s most feared question: How do you know everything is in control before you release product?
Contract Research & Services > Contract Services > White Papers
NSF: Learn from a Fabulously Successful GMP Remediation Program
| By NSF Health Sciences Pharma Biotech PBR
This White Paper describes a remediation program that appeared at first to be impossibly daunting, expensive and unattainable. The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment of the non-compliances; evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.
Contract Research & Services > Contract Services > White Papers
NSF: Remediation of Pharma Quality Systems – It’s All About the People
| By NSF Health Sciences Pharma Biotech PBR
Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems. This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.
Contract Research & Services > Contract Services > White Papers
New Vetter Data Processing Center is Officially Certified
IT experts of TÜV Süd, a German industrial testing organization, have certified the new data processing center at Vetter's headquarters in Ravensburg, Germany. The pharmaceutical service provider has fulfilled all requirements to meet the "TÜV Süd certified data processing center" criteria.
Contract Research & Services > Contract Services > Press Releases
Vetter's Skokie Site Successfully Manufactures Batches on New Clinical Syringe Filling Line
Vetter, a leading international contract development and manufacturing organization (CDMO) that specializes in aseptic filling for its (bio-)pharmaceutical customers, has announced today that its new clinical syringe line has already manufactured for its customers a double digit number of batches for use in early clinical trials.
Contract Research & Services > Contract Services > Press Releases
Vetter Starts Operations in its Center for Visual Inspection and Logistics
Vetter, a leading global Contract Development and Manufacturing Organization (CDMO) for development, aseptic filling and final packaging of injectables, has announced today that it has begun operations in its expanded Visual Inspection and Logistics Center located in Ravensburg.
Contract Research & Services > Contract Services > Press Releases

PBR Supplier Recommendations

NSF Health Sciences Pharma Biotech
NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, residential and on-site pharmaceutical training and clinical testing on a global basis. ... Contract Research & Services > Contract Services > Suppliers
Hybrigenics Services - Protein Interactions Expert
Who else knows your protein better than you? Who else knows proteins interactions better than us?... Contract Research & Services > Contract Services > Suppliers
Butterworth Laboratories Ltd – Experts in Pharmaceutical Analysis
Butterworth is a UK based contract laboratory providing pharmaceutical analysis in accordance with cGMP to the global pharmaceutical industry. We specialise in Quality Control, Method Development & Validation and Stability Storage & Testing. Our focus and expertise centre on raw materials but we also have experience of finished products and medical devices.... Contract Research & Services > Contract Services > Suppliers
Quintiles - Bringing People and Knowledge Together for a Healthier World
Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment.... Contract Research & Services > Contract Services > Suppliers
Vetter Pharma International - High-Quality Aseptically Pre-Filled Injection Systems
From preclinical development through commercial supply.... Contract Research & Services > Contract Services > Suppliers
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PBR White Paper Recommendations

Tech Talk: CHANGING GMP BEHAVIORS with NSF By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.... Contract Research & Services > Contract Services > White Papers NSF: KPIs and the Head of Corporate Quality: KPIs Are Essential for a Successful Product Release By NSF Health Sciences Pharma Biotech PBR
What are your views on KPIs? Essential or a necessary evil? “They are absolutely essential, providing they are good! I remember during a regulatory inspection I was asked every QP’s most feared question: How do you know everything is in control before you release product? ... Contract Research & Services > Contract Services > White Papers NSF: Learn from a Fabulously Successful GMP Remediation Program By NSF Health Sciences Pharma Biotech PBR
This White Paper describes a remediation program that appeared at first to be impossibly daunting, expensive and unattainable. The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment of the non-compliances; evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.... Contract Research & Services > Contract Services > White Papers NSF: Remediation of Pharma Quality Systems – It’s All About the People By NSF Health Sciences Pharma Biotech PBR
Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems. This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.... Contract Research & Services > Contract Services > White Papers Brexit Implications for UK Pharmaceutical Administration with NSF By NSF Health Sciences Pharma Biotech PBR
With the historic vote by the UK to leave the European Union we have been asked by many of our clients and colleagues “What will the vote to leave the EU (Brexit) mean for pharmaceutical quality management and the role of the Qualified Person (QP)?” The only thing that is certain is that we are facing at least two, and probably more, years of unprecedented uncertainty.... Contract Research & Services > Contract Services > White Papers See more
1-15 of 2918 results