Kellerman Consulting arrived to your rescue for me soon after working with A further competitor who remaining me in the dead of night. I had been so relieved to find a responsible, professional consulting business who could support a different operator out in building an entire blown HACCP system - and teach me alongside the best way!

Our team is made up of a various selection of market veterans and specialists in giving sensible assistance in complying with rules through your project lifecycle. Between our specialists, we’re happy to have a lot of previous GMP inspectors and field gurus who carry towards the table their personal familiarity While using the nuances and intricacies of GMP compliance through a venture lifecycle.

KNORS crew of pharma specialists rationally style and design good quality management systems and enable to put into practice via trainings.

By decades of connecting scientific operations experts with alternatives all over the world, we’ve formulated a big Energetic, and prolonged pool of gifted gurus.

Consulting provider: Our guide will evaluate your person circumstance and give you a professional assessment.

Our deep roots in strategy combined with our proprietary investigate, cross-practical Health care and lifestyle sciences experience, and relentless client centricity assist you corral seemingly disparate options into a coherent, orchestrated system of assault. Our pharmaceuticals and biotech consulting teams have deep practical experience supporting consumers reduce complexity, learn Sector 4.

This expertise permitted Ana to gain an in-depth understanding of the regulatory authorities’ anticipations and a comprehensive expertise in the EU and US GMP regulations. She’s also performed GMP inspections to third party international locations on EMA’s behalf.

Alex has held administration stage roles in Top quality Assurance, making sure item good quality & regulatory compliance, and also Senior Technological Supervisor positions accountable for CMO management, oversight and tech-transfer of pharmaceutical merchandise. This knowledge equips him properly in evaluating manufacturing methods for early period solutions, along with late phase and industrial solutions for EU and US marketplaces.

We can thus provide you with this consulting services in Each individual manner usual available in the market. The look evaluation can normally be completed with no corresponding on-web site existence, entirely based on the complex documentation about the general and in depth setting up of an installation.

Our GMP/GxP read more authorities preserve you over the Safe and sound aspect. We provide Expert guidance in the implementation of GxP-compliant good quality management systems.

- We be certain that your plant internet site fulfills your company aims although remaining totally compliant with the most recent Great Producing Observe polices and criteria.

Our High quality system ensure that our clients acquire individualized reports with regions most related for their operations.

As a result of mock inspections we’ll Verify that every one is correctly, and concentrate on remediation as needed.

For those who’re an ambitious start-up, a disruptive entrepreneur, a subsequent generation leader of a family company or perhaps a transformative CEO, we can help you obtain your advancement ambitions and make website a legacy to become proud of.