At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guideline you throughout the top quality compliance procedure.
We will evaluate your documentation and go to your facility, identify gaps in your existing application and facility operations, and we will let you fill These gaps as a way to go your audit.
As your husband or wife, we will negotiate the potential assessment minefield of regulatory compliance providers with insight, hindsight, and the apparent advantage of our breadth and depth of knowledge and regulatory compliance consulting. We provide the next pharma consulting regulatory affairs companies for pharmaceutical businesses.
An in-emphasis consider the Good Production Observe (GMP) audit environment And just how the idea of distant or Digital audits, a reasonably new strategy is staying adopted.
Our mission is always to accelerate innovation for any more healthy environment. Alongside one another, we will resolve purchaser difficulties and increase affected individual lives.
Unparalleled abilities: Our consultants have extensive marketplace encounter and an insider’s standpoint from their time as GMP inspectors. They may have stood on either side in the GMP compliance equation, furnishing them with a singular being familiar with that informs every single provider we offer.
The pharmaceutical field is filled with private knowledge, from patient data to demo final results to patented function; it is absolutely essential to protect this details and IP from any cybersecurity threat.
Law firms trying to find pharmaceutical consulting agency abilities inside the remediation of warning letters, consent decrees, 483’s or import bans
Even so advanced your life sciences supply chain, our seasoned authorities are here to help you attain and keep conclusion-to-end GMP compliance according to latest and rising laws.
Our GMP/GxP experts hold you within the Risk-free aspect. We offer Specialist help during the implementation of GxP-compliant high-quality administration methods.
Tim and Brian rallied about me and made positive I used to be all set to meet the problem head on. From producing and reviewing documents, to educating an entire amateur, to carrying out a mock audit upfront, the Kellerman group designed sure we were All set not just to get more info pass, but to score a 91 on our first audit. I couldn't recommend them extra extremely”!
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We generate tailor made projects in compliance with FDA / USDA regulatory specifications and GMP certification specifications for every organization we serve.