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We’ll do the job alongside you to implement your GMP certification application, ensuring that you know how to run it and you go your future audit.
GMP consultants with QA encounter know how Every single department during the Group interacts With all the production processes and systems. QA specialists have a complete photo in your mind when designing an outstanding management procedure and are exceptionally educated in federal, nearby, and Expert expectations.
By way of a long time of connecting medical functions professionals with alternatives around the world, we’ve produced a significant active, and prolonged pool of gifted specialists.
Produce and disseminate evidence that answers very important medical, regulatory and business inquiries, enabling you to push smarter decisions and meet up with your stakeholder wants with self-assurance.
We realize the complexities of running a lifetime science organization and have regions of experience that include each and every facet of R&D, functions, regulatory affairs, excellent, and production.
From R&D to supply chain and operations to every aspect of commercialization, pharma and biotech corporations really have to execute flawlessly across all dimensions if they hope to earn.
Firms using a client-centered solution are superior equipped to establish personalized connections for his or her people and meaningfully engage with them all through the total treatment method journey.
I hugely advocate working with Kellerman Consulting. Working with Brian Kellerman set me at ease. He’s incredibly educational, affected person, and took enough time to walk me by the method. An throughout great dude! If ever I would like the services this company provides I’ll appear no further.
Our full-time GMP consultants reply right away to all client inquiries, which displays one among our Main values.
Tim and Brian rallied about me and built positive I used to be wanting to meet the obstacle head on. From creating and examining documents, to educating a whole newbie, to performing a mock click here audit beforehand, the Kellerman group designed confident we ended up Completely ready don't just to pass, but to attain a 91 on our 1st audit. I could not advise them extra hugely”!
- Becoming a member of our IGAP program/ Audit report library is no cost for suppliers/manufacture. Our experienced and skilled auditor will carry out comprehensive web-site audit check here of supplier masking substantial variety of molecules/products and solutions (Otherwise already carried out) without having charge to supplier and specific audit report shall be ready.
PJC Pharma Consulting provides a client-focused pharmaceutical consultancy and parenteral consultancy assistance, presenting complex guidance for solution growth, instruction, vital method testimonials, audits and challenge management. With 30 years’ knowledge from the pharmacy/pharmaceutical sector, we deal with a spectrum of assignments from generic portfolio growth and registration to unit development and registration, and new chemical entity improvement to medical period.
When you are while in the strategy of making ready for an inner, exterior, or approaching regulatory inspection, we will support you with entire dedication and professional expertise by our experienced and skilled consultants.