We offers turnkey top quality answers and focuses on providing Fantastic Value success, while maintaining best high-quality requirements for our Shoppers.
Our group is composed of a various choice of market veterans and professionals in giving functional guidance in complying with rules in the course of your challenge lifecycle. Amongst our experts, we’re happy to possess a lot of previous GMP inspectors and market industry experts who carry towards the table their intimate familiarity Along with the nuances and intricacies of GMP compliance all through a venture lifecycle.
Using a put together tenure across our companies of approximately two hundred several years and our field-identified scientific and technological experience, we assist to ensure the security of over a hundred ninety million individuals and Health care practitioners worldwide each and every year.
Functioning with the Preliminary progress action phase, applicant selection, via scale up and complex transfer in to the factory network, our experience in validation and microbial assessment from the manufacturing method, threat assessments and medical demo models may be invaluable when placed on your portfolio.
Operational Excellence Marketing consultant & Lean Manufacturing Specialist can assist you with a holistic method of realize the specified objectives of your respective organization. Tetrahedron deploys many applications and procedures, These align the organization’s culture, permit workforce, and sustain all carried out initiatives.
Conventional Running Procedures (SOPs) and all supplementary top quality administration files (QMS) ought to be optimally personalized to each other also to the organization's Corporation to empower effective and faultless work in accordance with the respective guidelines.
“Larsen Packaging Products is appreciative to Kellerman Consulting and our contact Tim Grady for aiding us in getting our GMP certification. Tim walked this journey with us from beginning to finish and was always accessible to remedy any questions and help us in developing methods, sorts, etc.
With much more than twenty years of knowledge with FDA, Health Canada, EU and world wide regulatory agencies worldwide, Regulatory Compliance Associates® features primary pharmaceutical consultants. We’re among the list of couple pharma consulting businesses which can help you navigate the problems connected to industry rules.
We don’t unfold ourselves slender across several industries. Instead, we give attention to delivering a deeper, richer bench of lifestyle science talent at the speed you will need. Our massive workers of internal methods and prolonged worldwide community supply usage of specialists wherever you would like them.
For the more info duration of your free GMP consultation, you’ll understand get more info what the necessities are for acquiring Licensed, exactly how much it fees with no concealed charges, how long it will require, and how our method will work to guarantee you move your GMP certification audit on the very first try out.
Our World Lifetime Sciences sector can help you navigate ahead and accomplish sustainable accomplishment in The brand new health and fitness-outcomes-driven ecosystem.
All of our comprehensive-time GMP consultants are very well-versed in Kellerman Consulting’s repeatable and trustworthy method. Our group’s collaborative culture provides you with the benefit of our collective expertise with many prosperous results.
PJC Pharma Consulting presents a customer-targeted pharmaceutical consultancy and parenteral consultancy provider, featuring specialized direction for item development, schooling, vital course of action reviews, audits and project administration. With thirty several years’ expertise inside the pharmacy/pharmaceutical industry, we go over a spectrum of tasks from generic portfolio progress and registration to gadget advancement and registration, and new chemical entity improvement to scientific section.
Prior to the introduction of medicinal goods to the market, the laws of excellent Apply (GxP) need to be followed all through production and advancement.