Irrespective of whether you’re while in the item setting up, advancement or pharmaceutical lifecycle management stage or have to have a remediation system for your compliance crisis, Regulatory Compliance Associates will guideline you through just about every pharmaceutical consulting step on the regulatory procedure.
As your associates, Regulatory Compliance Associates can negotiate the probable minefield of regulatory compliance and regulatory homework with Perception, hindsight, and also the apparent benefit of our exclusive skills and encounter.
- When report necessary on urgent basis to aid the provision, regulatory submissions etcetera., When producing internet site can’t accommodate the audit resulting from hectic plan, When vacation restriction; Sponsor might get Positive aspects by obtaining our IGAP experiences from our report database, In addition our customers only spend a small fraction of the costs normally related to conducting a supplier audit.
An in-concentration take a look at The nice Production Follow (GMP) audit environment And just how the concept of distant or virtual audits, a fairly new notion is being adopted.
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As your partners, Regulatory Compliance Associates can negotiate the probable minefield of regulatory compliance and regulatory research with Perception, hindsight, and also the obvious benefit of our unique skills and practical experience.
This practical experience allowed Ana to realize an in-depth idea of the regulatory authorities’ expectations and an extensive understanding of the EU and US GMP laws. She’s also done GMP inspections to 3rd party international locations on EMA’s behalf.
Since 2017, our Excellent Production Methods (GMP) consultants have assisted many hundreds of customers all through the foods supply chain to have GMP certified. GMP is an important foundational program needed of numerous makers to make sure goods are consistently made to your website significant typical.
Make and disseminate evidence that solutions crucial medical, regulatory and professional thoughts, enabling you to definitely push smarter selections and satisfy your stakeholder requires with confidence.
Zero Breakdown: Routine maintenance is focused check here on Performing for the last word target having a profitable upkeep strategy.
Laura with Kellerman Consulting is just fantastic. She is very useful, straightforward to operate with and obtained us via our GMP audit that has a a lot better score than we expected. Also, the Business of every one of the documents Kellerman Consulting offered us with is superb.
Staying in compliance with GMPs or cGMPs will not be the same as currently being Accredited. In order to obtain GMP or cGMP certification, you need to hire a 3rd-occasion auditing organization to evaluate your practices towards GMP or cGMP criteria.
You may commission us With all the complete conception and document development for your personal QMS or have our industry experts accompany or employ the processing of specific focal points.
With over 20 years of expertise with FDA, Well being Canada, EU and global regulatory organizations around the world, Regulatory Compliance Associates® provides top pharmaceutical consultants. We’re one of several handful of pharma consulting firms which will help you navigate the issues connected with market polices.