Hoffman Healthcare Consultancy have the expertise to launch any pharmaceutical or medical device product, with over 25 years of world class experience.
Our clients include Astra Zeneca, Novartis, The Medical Device Consultancy of the UK, Fresenius-Kabi, The Gates Foundations, and the NHS.
Hoffman Healthcare Consultancy have you covered:
Pharmaceutical GMP training and mentorship
Design and set up of large scale manufacturing sites in line with global cGMP regulations, including FDA, EMA, MHRA.
Regulatory consultancy & license submission, including preparation of regulatory dossiers and submission to competent authorities.
Preparation for regulatory, competent authority inspections, specialised in FDA, MHRA & EMA inspections.
Quality Management System implementation and remediation in line with industry standards ISO 13485, 21 CFR part 820, MDSAP, ISO 14971, IEC 62304.
Validation and Design Verification engineering and consultancy.
And more
Hoffman Healthcare Consultancy has an unprecedented track record and portfolio of pharmaceutical and medical device launches that is second to none!
Hoffman Healthcare Consultancy Information Hub
Axol caught up with Simon Hoffman, to hear what he thought of the FDA Modernization Act 2.0 and how it will impact drug discovery:
Our latest blog post – https://hoffmanhealthcareconsultancy.com/2023/06/21/how-to-maintain-a-traceability-matrix/ – Updates, thoughts and guidance.
FDA update June 2023
Guidance document for Content of Premarket Submissions for Device Software Functions.
This guidance document replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005.
Concerned about MDR and the extended transition deadlines? Hoffman Healthcare Consultancy have been aware of MDR requirements years in advance of its publication and understand exactly what’s needed.
DRIVERS OF INNOVATION
Don’t be defeated. We know MDR can be challenging and with the extended periods for moving over to the new regulations you may be tempted to take more time to transition, take your medical device development elsewhere, or even forget an idea completely.
However, we know this isn’t feasible for many of you and now is not the time to take your foot off the pedal.
Hoffman Healthcare Consultancy are up to date with all things MDR. We’re ready for preparation, authoring and submission of technical files and design history files for global Medical Device launches in line with industry requirements. Medical Device Regulation (EU) MDR 2017/745, as well as FDA 510k and In-Vitro Diagnostic Regulation IVDR (EU) 2017/746.
Let us guide you through and enable you to be the drivers of innovation we know you are.
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