Whether or not you’re during the product preparing, advancement or pharmaceutical lifecycle management stage or require a remediation method for any compliance disaster, Regulatory Compliance Associates will guide you through each pharmaceutical consulting stage on the regulatory approach.
Get marketing materials in to the lifetime sciences sector far more immediately, even though lowering pitfalls and slicing expenses, Together with the EY Intelligent Reviewer.
Personalized solutions for every application, with tailored procedures intended to satisfy extremely certain wants. We’ve realized lots about what is effective and what doesn’t. Browse the newest learnings and insights from our medical development industry experts.
Therefore, all supplier qualification steps add to the overall aims of medicinal products security, performance and compliance.
Tailored remedies: No two businesses are precisely the same, and we respect these differences by tailoring our consulting solutions towards your Group’s distinctive requirements, situations, and problems. We provide bespoke answers created to deal with your unique GMP compliance hurdles head-on.
“Kellerman Consulting was professional, economical, and proceeds to show their support and guidance even following the GMP audit”.
“Larsen Packaging Goods is appreciative to Kellerman Consulting and our Make contact with Tim Grady for helping us in obtaining our GMP certification. Tim walked this journey with us from beginning to close and was generally accessible to response any thoughts and guide us in producing methods, forms, and so on.
Regulatory affairs is Regulatory Compliance Associates spine. We exceed other pharma consulting corporations with industry specialists expert in complexities of your pharmaceutical and biopharmaceutical industries.
However complex your life sciences source chain, our expert specialists are here that will help you accomplish and sustain end-to-conclude GMP compliance in line with latest and rising restrictions.
Our specialists performs third party evaluation and hole Examination having a quantified Instrument to assess the corporate’s point out of regulatory compliance. We assist the companies in coming up with CAPA for deficiencies elevated by regulatory inspections.
Most FDA GMP consultants can have GMP consulting knowledge which is a crucial qualification since they have got had alternatives to work with several providers and in numerous settings. The importance of operational knowledge, on the other hand, should not be missed.
Being an extension of one's GMP Auditing workforce, we’re capable of conduct audits with your behalf, utilizing your established audit system or the ADAMAS process, whichever get more info functions very best for your needs.
The field of cell and gene therapy is evolving immediately and dealing with continued technological, regulatory, and commercialization hurdles.
Forecasting & Franchise here Approach Bolster your portfolio by making a lot more educated selections and get ready with the effect of new research discoveries.