“Kellerman Consulting acted like a trainer for our new QC use, so we benefited from that as well as the successful preparation with the SQF audit. We obtained a ninety eight% to the audit. That ought to discuss for itself.
We realize the assorted concerns and challenges you experience with your strategy to reaching GMP compliance while in the pharmaceutical, biotechnology, ATMP and professional medical product producing industries - and we develop functional, achievable and price-effective solutions for you.
As your husband or wife, we are able to negotiate the possible evaluation minefield of regulatory compliance expert services with insight, hindsight, as well as the clear benefit of our breadth and depth of knowledge and regulatory compliance consulting. We provide the subsequent pharma consulting regulatory affairs services for pharmaceutical providers.
Anxious your high-quality system isn't going to mirror FDA anticipations? Connect with former FDA and sector gurus which have intensive familiarity with FDA's latest inspection approaches and anticipations that go beyond the phrases of regulation.
Our pharmaceutical consulting Professionals will develop a custom-made strategy determined by your product or service and enterprise’s specific desires. Our regulatory compliance clients contain:
Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting corporations with market authorities seasoned click here in complexities on the pharmaceutical and biopharmaceutical industries.
Our GMP professionals have working experience auditing programs versus applicable regulatory and sector requirements. Our authorities work with you to use the proper benchmarks based on your needs, the pursuits or expert services delivered, as well as the phase of one's task.
PJC Pharma Consulting presents bespoke job administration products and services into the pharmaceutical field. This will include an evaluation of present progress programs and protocols, or even the making of new programs together with your enhancement groups, getting into account get more info hazard analysis and development constraints.
We don’t spread ourselves slender across a variety of industries. Alternatively, we concentrate on furnishing a deeper, richer bench of everyday living science expertise at the rate you'll need. Our significant staff members of internal assets and extended world-wide community provide access to professionals anywhere you'll need them.
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As the marketplace grows more substantial and competitive, the war for high-quality expertise is gaining momentum. This requires Skilled experience in pinpointing, sourcing and engaging potential-All set talent.
The normal scope of a design and style review could vary from viewing only one place or an entire facility. In addition to GMP compliance the manufacturing capability and clients solution spectrum Enjoy a substantial role during the analysis process.
Do you need support or assistance on supplier qualification? Call us and tell us about your prerequisites. Collectively we discover the best possible Option.
A vital prerequisite for the efficient and simple application of the quality assurance tools may be the deep knowledge about choices and variation.