Get expert guidance at every stage on the merchandise lifecycle. We assist daily life science companies quickly accessibility the field's very best consultants, contractors, and candidates. Our means guide in every stage from the item lifecycle.
Zero Loss: Zero Decline is surely an purpose/attempt to overcome these losses or decrease their result nearly great extent as a way to lessen the producing Value.
I'd come to Shelby Foods just 4 months ahead of the First BRCGS audit and experienced very little plan what was required for BRCGS. Brian labored with me and patiently answered all my issues right until I understood all the things.
The truth is some cGMP consultants do not approach adequately and infrequently take on a lot of initiatives. An initial Assembly with the GMP specialist to discuss the challenge particulars should occur. After the Assembly, an in depth SOW need to outline the things important to the customer that should be reviewed or assessed by the cGMP guide. The comprehensive SOW ought to include things like the deliverables the consumer will obtain. The deliverables will fluctuate dependant upon the task details but is usually a report of tips, conventional running procedures, or tools validations.
Kellerman Consulting held my hand each and every step of how (and rely on me I needed it)! Kellerman Consulting received me by means of all of my approvals with an very easy to abide by HACCP system that appeased a USDA regional manager.
“Kellerman Consulting was Experienced, efficient, and carries on to show their aid and direction even after the GMP audit”.
Extensive preparing of Guidelines: Our industry experts make extensive Directions for all essential top quality assurance resources.
Alex has held administration degree roles in Top quality Assurance, ensuring item high-quality & regulatory compliance, and also Senior Technological Manager positions chargeable for CMO management, oversight and tech-transfer of pharmaceutical merchandise. This encounter equips him perfectly in analyzing producing programs for early stage products and solutions, and late stage and professional solutions for EU and US marketplaces.
Already throughout enhancement and formulation, the very first compliance measures once and for all Manufacturing Follow (GMP) need to be implemented. These essentially include things like all GMP appropriate topics that are to generally be applied on a danger-primarily based technique based on the respective growth phase.
Our industry experts performs 3rd party analysis and gap Assessment that has a quantified tool to assess the corporation’s state of regulatory compliance. We enable the companies in planning CAPA for deficiencies elevated by regulatory inspections.
Having a merged tenure throughout our enterprises of just about 200 a long time and our sector-recognized scientific and technological expertise, we assist to make sure the basic safety of more than 190 million individuals and Health care practitioners around the world every year.
All of our comprehensive-time GMP consultants are very well-versed in Kellerman Consulting’s repeatable and reputable method. Our group’s collaborative lifestyle offers you the advantage of our collective expertise with numerous effective outcomes.
You are able to commission us While using the detailed conception and document generation in your QMS or have our professionals accompany or put into practice the processing of person focal points.
With over twenty years of check here experience with FDA, GMP consultants in India Health copyright, EU and global regulatory businesses around the world, Regulatory Compliance Associates® delivers major pharmaceutical consultants. We’re among the handful of pharma consulting providers that can help you navigate the difficulties related to market laws.