Lots of firms elect to employ consultants to supply enterprise assistance companies to correctly get ready for certification audits . Kellerman Consulting will publish & put into action food items basic safety and high quality packages which might be tailor-made to your item and procedure.
Our crew of specialists has efficiently completed quite a few gap analyses in over the last twenty years and features this consulting services for all GMP devices.
Although these troubles are external components can’t be managed by any business. The a person and only way to remain sustainable is by a structured Production Excellence Method.
We realize the complexities of running a everyday living science enterprise and possess regions of experience that come with each individual aspect of R&D, functions, regulatory affairs, high quality, and producing.
Consulting services: Our specialist will Examine your particular person situation and present you with an authority evaluation.
The definition with the scope for being analyzed is the responsibility with the customer. In the event of extensive hole analyses, the GMP/GxP consultant carrying out the Evaluation could advise clarification of interfaces or transitions amongst personal analyses.
Our Operational Excellence in Manufacturing method helps corporations to overcome troubles by producing and deploying top-tier company techniques. For a lean production specialist, we Engage in a pivotal function in successful business transformations.
Certain provide chain with qualified suppliers and sturdy procedures is ultimately The premise for reducing complaints and making certain medicinal product or service basic safety.
Besides parenterals PJC Pharma Consulting can present an array of assist for other dosage varieties, from prospect range by to NDA/MAA submissions, both equally For brand new chemical entities and merchandise line extensions (PLEs) of a number of oral dosage formulations: Tableting
The modern period over the condition of art production facilities (planet-course facility) is built and constructed in accordance with stringent cGMP specifications.
Due to the fact we don’t just provide current market info, we leverage the latest technologies, advance analytics and Health care information to deliver insights that permit excellence in execution check here from molecule to market.
As an extension of your respective GMP Auditing workforce, we’re able to carry out audits on your behalf, using your proven audit application or the ADAMAS system, whichever is effective greatest for your needs.
cGMP website can be a action-up from GMP specifications and is needed for dietary dietary supplement suppliers. cGMP usually means Present-day Great Producing Apply. cGMP laws need further solution screening plus more complete excellent management units set up.
Scientific Operations Demand for talented clinical operations specialists grows every day. How would you discover the useful resource you may need whenever you have to have them?