Kellerman Consulting arrived on the rescue for me soon after dealing with A different competitor who left me at midnight. I used to be so relieved to find a dependable, knowledgeable consulting company who could enable a brand new operator out in establishing an entire blown HACCP prepare - and educate me alongside just how!
Gap Evaluation is really a classical consulting Resource to align the current Along with the goal standing. It relates possibly to the whole GMP method of the controlled organization or to person subareas.
Regulation firms trying to get pharmaceutical consulting business abilities in the remediation of warning letters, consent decrees, 483’s or import bans
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Common Running Methods (SOPs) and also all supplementary excellent administration documents (QMS) need to be optimally tailor-made to one another also to the company's Firm to help productive and faultless work in accordance Together with the respective principles.
Whether or not you’re within the merchandise setting up, progress or pharmaceutical lifecycle management stage or need a remediation tactic for a compliance crisis, Regulatory Compliance Associates will tutorial you through every single pharmaceutical consulting move with the regulatory system.
Alex has held management level roles in Excellent Assurance, making certain merchandise top quality & regulatory compliance, and also Senior Technical Supervisor positions chargeable for CMO management, oversight and tech-transfer of pharmaceutical solutions. This encounter equips him effectively in evaluating producing programs for early stage goods, in addition to late period and business goods for EU and US markets.
Not merely did our audit rating mirror how fantastic their technique will work, but I also acquired so a great deal more idea of SQF and self-assurance as an excellent Supervisor!”
We support web-site for effectively passing inspections and layout article-inspections remediation ideas to determine & enhance GMP compliance and sustain approval for the item with Pharmexpert's tailor-made and cost-helpful read more plans for Excellent Administration for Pharmaceuticals, Bio-Pharma and MD.
In the event medicinal products shall be created for your medical demo, a producing authorisation as well as a corresponding GMP certificate are presently expected for this objective.one
STRATEGIC DRUG Progress Push technique by way of professional regulatory Perception and advice Marketplace-top therapeutic and functional region industry experts enable purchasers glean appropriate regulatory insights from world-class knowledge, enabling genuine-time resolve and analysis of your time, cost and hazard.
As these paperwork tend to be the critical to an productive and mistake totally free operation in the GMP unit, they should in good shape to each other and also to the dimensions of The client aspect.
These are a pleasure to operate with. I've a whole website lot to perform and am extremely chaotic – they outlined anything out in a really realistic vogue and acquired The work completed inside the precision and detail we needed it being. I'd personally work with them yet again!