Get skilled aid at every stage from the product lifecycle. We assist existence science companies promptly obtain the business's greatest consultants, contractors, and candidates. Our sources assist in just about every phase in the item lifecycle.
We are going to evaluate your documentation and take a look at your facility, detect gaps as part of your current application and facility operations, and we will help you fill Those people gaps in order to go your audit.
As your companion, we could negotiate the likely assessment minefield of regulatory compliance providers with insight, hindsight, and the very clear advantage of our breadth and depth of data and regulatory compliance consulting. We offer the next pharma consulting regulatory affairs expert services for pharmaceutical firms.
Via years of connecting medical operations authorities with options around the world, we’ve produced a big active, and prolonged pool of proficient industry experts.
Our mission will be to speed up innovation for a healthier earth. Jointly, we can solve purchaser issues and strengthen client lives.
We're deeply knowledgeable GxP consultants, auditors and practitioners. We proactively enable pharmaceutical and health care unit businesses worldwide with all areas of their production and provide chain high quality assurance and involved business enterprise course of action optimisation.
“Larsen Packaging Goods is appreciative to Kellerman Consulting and our Make contact with Tim Grady for assisting us in acquiring our GMP certification. Tim walked this journey with check here us from beginning to finish and was always accessible to reply any inquiries and aid us in developing methods, varieties, and so on.
Specifically, the following elements must be documented and ensured: description of the internal processes, the suitability of all premises and facilities, the conformity of elements employed, the qualification in the staff and the caliber of exterior companies.
Together with parenterals PJC Pharma Consulting can supply a wide range of help for other dosage kinds, from candidate range by way of to NDA/MAA submissions, both For brand new chemical entities and solution line extensions (PLEs) of several oral dosage formulations: Tableting
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We have an understanding of the complexities of managing a lifetime science company and have locations of expertise that come with each individual aspect of R&D, functions, regulatory affairs, top quality, and production.
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- 360 degree audit method To guage the capabilities and top quality techniques of suppliers and out-sourcing companions
We could offer GMP providers for specific niche options for your personal difficulties together with thorough offers that include all GMP necessities arising from the context of pharmaceutical producing pursuits.