We got through our audit and we are incredibly happy to obtain been given a ninety nine.37% score. I happen to be Operating For numerous, many years and it is rather refreshing to work with someone that can be so Experienced and do what they say they'll do and continue to take care of individuals with kindness.
Our group of authorities has properly completed a lot of hole analyses in throughout the last twenty years and offers this consulting company for all GMP devices.
We assist 1000s of firms, which include 17 of the highest 25 international pharmaceutical, biotech, and healthcare device firms, hook up Using the specialists they have to have from the exceptional workforce design.
We fully grasp the complexities of jogging a life science enterprise and have areas of experience which include each individual facet of R&D, operations, regulatory affairs, top quality, and manufacturing.
Our pharmaceutical consulting Specialists will create a tailored strategy based upon your products and corporation’s specific requires. Our regulatory compliance customers include:
Regular Functioning Strategies (SOPs) along with all supplementary top quality management documents (QMS) must be optimally tailor-made to each other and to the organization's Firm to permit efficient and faultless function in accordance Using the respective regulations.
Kellerman Consulting crew associates are held up-to-date on each individual venture, making sure that any one of our consultants can certainly step in at any moment to give you the reliability and responsiveness your venture warrants.
Alex has held management level roles in High quality Assurance, ensuring products good quality & regulatory compliance, together with Senior get more info Complex Supervisor positions responsible for CMO administration, oversight and tech-transfer of pharmaceutical products. This expertise equips him nicely in assessing producing units for early stage items, along with late section and industrial solutions for EU and US markets.
Not just did our audit rating replicate how good their technique operates, but I also obtained so considerably more idea of here SQF and self-confidence as a high quality Supervisor!”
Partnering with others to share knowledge, drugs and resources when anticipating developments and regulatory modifications will help be certain sustainability during the increasingly proof-primarily based, results-centered sector.
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Consultants get ready the space e book, which incorporates right and distinct information regarding Each individual room especially.
M&A Attain constantly increased returns with a scientific and repeatable approach to mergers and acquisitions
In case you are in the technique of planning for an internal, external, or future regulatory inspection, we could help you with full determination and professional knowledge by our trained and expert consultants.