Applying Lean & Six Sigma methodologies to all stages of Pharmaceutical Product & Process Development
Selecting the correct partner to support your business is critical to success.
Based in Waterford, QBD Pharma Solutions have over 40 years’ experience working with Pharmaceutical, Biopharmaceutical and Medical Device companies.
We create value for our Irish and international clients by applying Lean & Six Sigma methodologies to all stages of Product & Process Development, accelerating your time to market and increasing return on investment.
At QBD Pharma Solutions we use our experience to provide tailored solutions to meet your specific needs. Our services range from support and advice to training and development across the Pharmaceutical, Biopharmaceutical and Medical Device industries.
Pharmaceutical Development & CMC support
High Potency Manufacture
Lean & Six Sigma
Dossier Compilation & Due Diligence for M&A
Quality & Regulatory Inspection Preparation
Tech Transfer & Process Validation
R&D Tax Credits
Training & Development
Chemistry, Manufacturing and Controls (CMC) is vital part of your regulatory filing. Get this wrong and your product will be denied approval by the relevant authority.
Regulators need to be assured that there is consistency between product developed for clinical trials and that which goes to market.
Manufacture of high potency products represent a rapidly growing market with its own specific set of opportunities & challenges.
While our primary concern is ensuring that these compounds can be handled safely, manufacture and supply of your finished products require detailed forward planning to avoid additional costs or non-compliances in the future.
Lean Six Sigma is a powerful approach to dramatically improving your business processes through eliminating waste and increasing quality and efficiency.
By integrating Lean and Six Sigma tools and methodologies we provide a comprehensive and proven approach that can transform your organisation.
Note: QBD are an Enterprise Ireland approved vendor for ‘Lean Business Offer’ supports
Writing of Pharmaceutical Development Reports and compilation of technical dossier sections can be a daunting task. At QBD we have vast experience of writing, reviewing, and submitting regulatory documentation for NDA, ANDA and NADA filings.
Reviewing dossiers for the purposes of in-licensing or M&A is vitally important to ensure value creation in your business. We can critically assess, identify gaps, and advise on the completeness of data packages and technical reports to predict the chances for approval by relevant regulatory authorities
Your Pharmaceutical Quality System (PQS) is the foundation upon which you build your pharmaceutical business. A robust PQS is essential to ensure your medicinal products are fit for their intended use, comply with relevant authorization requirements, and do not place patients at risk due to inadequate safety, quality or efficacy.
We apply Quality by Design to quality risk management. This strategic and systematic approach facilitates a faster, easier and more cost effective product to market pipeline.
Executing Technical Transfer and Process Validation activities Right First Time is key to ensuring manufacturing challenges are quickly overcome, efficiency is maximized, and the end result is a robust and reliable process.
At QBD Pharma Solutions we can facilitate seamless TT and PV activities by effectively managing and mitigating risks and by implementing robust Project Management principles
Money spent by your company on a range of R&D and process improvement activities may qualify for the R&D Tax Credit. The credit is calculated at 25% of qualifying expenditure and is used to reduce your company’s Corporation Tax.
We can help you identify these opportunities and to put in place processes that will satisfy Revenue expectations ensuring you achieve the maximum benefit of the tax credit.”
We provide customer specific training & development programmes both online and on-site in your company.
QBD Pharma Solutions are an approved vendor for the delivery of Enterprise Ireland’s Lean Business Offer.”
Chemistry, Manufacturing and Controls (CMC) is vital part of your regulatory filing. Get this wrong and your product will be denied approval by the relevant authority.
Regulators need to be assured that there is consistency between product developed for clinical trials and that which goes to market.
Manufacture of high potency products represent a rapidly growing market with its own specific set of opportunities & challenges.
While our primary concern is ensuring that these compounds can be handled safely, manufacture and supply of your finished products require detailed forward planning to avoid additional costs or non-compliances in the future.
Lean Six Sigma is a powerful approach to dramatically improving your business processes through eliminating waste and increasing quality and efficiency.
By integrating Lean and Six Sigma tools and methodologies we provide a comprehensive and proven approach that can transform your organisation.
Note: QBD are an Enterprise Ireland approved vendor for ‘Lean Business Offer’ supports
Writing of Pharmaceutical Development Reports and compilation of technical dossier sections can be a daunting task. At QBD we have vast experience of writing, reviewing, and submitting regulatory documentation for NDA, ANDA and NADA filings.
Reviewing dossiers for the purposes of in-licensing or M&A is vitally important to ensure value creation in your business. We can critically assess, identify gaps, and advise on the completeness of data packages and technical reports to predict the chances for approval by relevant regulatory authorities
Your Pharmaceutical Quality System (PQS) is the foundation upon which you build your pharmaceutical business. A robust PQS is essential to ensure your medicinal products are fit for their intended use, comply with relevant authorization requirements, and do not place patients at risk due to inadequate safety, quality or efficacy.
We apply Quality by Design to quality risk management. This strategic and systematic approach facilitates a faster, easier and more cost effective product to market pipeline.
Executing Technical Transfer and Process Validation activities Right First Time is key to ensuring manufacturing challenges are quickly overcome, efficiency is maximized, and the end result is a robust and reliable process.
At QBD Pharma Solutions we can facilitate seamless TT and PV activities by effectively managing and mitigating risks and by implementing robust Project Management principles
Money spent by your company on a range of R&D and process improvement activities may qualify for the R&D Tax Credit. The credit is calculated at 25% of qualifying expenditure and is used to reduce your company’s Corporation Tax.
We can help you identify these opportunities and to put in place processes that will satisfy Revenue expectations ensuring you achieve the maximum benefit of the tax credit.”
We provide customer specific training & development programmes both online and on-site in your company.
QBD Pharma Solutions are an approved vendor for the delivery of Enterprise Ireland’s Lean Business Offer.”
Send us a message or Book a Consultation.
Choose ‘Consulting & Contract Support’ or ‘Training & Development’
and we’ll get back to you shortly
Ken O’Shea
p: 085 1631588
e: info@qbd.ie
workLAB, IDA Business Park, Cork Rd,
Waterford, X91 DC96
Ken O’Shea
p: 085 1631588
e: info@qbd.ie
workLAB, IDA Business Park, Cork Rd,
Waterford, X91 DC96