A lot of corporations opt to employ consultants to supply company aid providers to adequately put together for certification audits . Kellerman Consulting will compose & put into action meals basic safety and high-quality courses which can be customized for your product and approach.
Their first-hand encounter and insights from the sector set us apart, allowing us to deliver Extraordinary provider grounded in useful expertise.
Our pharmaceutical consulting Experts will develop a custom-made technique determined by your products and corporation’s individual desires. Our regulatory compliance clientele involve:
Functioning within the Preliminary advancement exercise stage, candidate collection, by scale up and technical transfer in to the manufacturing unit network, our knowledge in validation and microbial assessment from the producing approach, chance assessments and clinical demo models is usually invaluable when placed on your portfolio.
Our crew of knowledgeable regulatory scientists can publish the nonclinical, medical, and CMC sections in CTD and common structure for the new drug and biologic applications.
Regulatory Compliance Associates High-quality consulting consists of assessments, technique, implementations, staff members augmentations, and identification of top quality metrics to ensure continual advancement. Our pharma consultants recognize the strategic pondering needed to align your enterprise needs and targets.
Whether or not you’re during the solution arranging, progress or pharmaceutical lifecycle administration phase or need a remediation system for just a compliance crisis, Regulatory Compliance Associates will tutorial you through every single pharmaceutical consulting step of the regulatory GMP consultancy procedure.
We could create straightforward engineering prototypes which can be tailored to the useful and location needs and advise Value-effective options that comply with regulatory prerequisites. The subsequent project definitions are going to be described throughout primary engineering:
Don't just did our audit rating mirror how fantastic their process operates, but I also received so way more idea of SQF and self-assurance as an excellent Manager!”
Make sure the caliber of your merchandise by putting together a QMS. Valicare's specialists will guidance you with QM consulting, document planning & implementation.
Whether you’re within the products setting up, improvement or pharmaceutical lifecycle management phase or have to have a remediation approach for just a compliance crisis, Regulatory Compliance Associates will guideline you through just about every pharmaceutical consulting move from the regulatory course of action.
All of our whole-time GMP consultants are well-versed in Kellerman Consulting’s repeatable and dependable procedure. Our staff’s collaborative lifestyle provides the good thing about our collective practical experience with hundreds of successful outcomes.
You will accomplish the same 100% achievements price irrespective of which of our crew users you're employed with. You might receive a food safety & high-quality roadmap for receiving your item Licensed.
“They can be so Specialist and it had been just a real satisfaction Doing work via all the things. I might Certainly advocate Kellerman Consulting. I already have. When people talk to me pharma consultants in India about the SQF consulting course of action, I would not hesitate to state," undoubtedly simply call Kellerman Consulting'' ” .