If you have a regulatory audit coming up, be sure to are Completely ready by getting a pre-audit by amongst our experienced consultants.

Regulatory Compliance Associates Good quality consulting involves assessments, strategy, implementations, team augmentations, and identification of high quality metrics to be certain ongoing improvement. Our pharma consultants have an understanding of the strategic thinking needed to align your enterprise needs and ambitions.

Regulatory Compliance Associates pharma regulatory consultants will establish an extensive proof guide of documented proof demonstrating the corrective action taken to remediate non-compliant difficulties.

Several small-medium corporations want rapid certification to strike deadlines for proposal submittal, authorities contracts, as well as other urgent desires. We satisfaction ourselves on our capacity to meet up with your objectives.

which were critical on the productive completion of this process. I'd personally hugely suggest Kellerman Consulting for virtually any of your respective consulting desires as they were pretty Expert and ensured that each one objects ended up addressed previous to our audit. “

GMP is important for licensing and registering merchandise in Malaysia, ensuring compliance with restrictions. It serves as being a assure for solution good quality, taking part in an important job in preserving general public wellbeing.

Overall health Care Sector We operate with companies round the world to remodel wellness treatment working products enabling them to deliver health care breakthroughs, ground breaking cures, and transformative client ordeals.

“We partnered with Kellerman Consulting very early on within the SQF certification system, and by relying on their experience and methodical method of accumulating, compiling, and organizing the expected documentation, we had been prosperous here in getting our certification.

How can we get it done? By Doing the job intently with the workforce and by following our repeatable and trustworthy process.

In the last few a long time, Metina has designed abilities in the region of Biosimilars and Vaccines and we are actually Geared up to take on conclusion-to-close regulatory help for this group of merchandise throughout BRICS-TM (together with India) nations around the world and controlled marketplaces.

We'll write your provider acceptance software, perform alongside you to website apply it, and teach you to keep it managing.

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Commissioning, Qualification & Validation We perform with our shoppers to develop scalable resource programs to aid validation efforts through the entire undertaking lifecycle. Whether it's drafting protocols to execution and compilation of information packs, our methods have you included.

With more than twenty years of practical experience with FDA, Wellbeing Canada, EU and worldwide regulatory agencies throughout the world, Regulatory Compliance Associates® features major pharmaceutical consultants. We’re one of several couple of pharma consulting corporations that will help you navigate the challenges linked to industry polices.