At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants needed to information you throughout the excellent compliance system.
Also, each Regulatory Compliance Associates pharma consulting Qualified understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to guide with your remediation efforts, generate ongoing improvement, and keep regulatory compliance Along with the rules.
As your husband or wife, we could negotiate the potential evaluation minefield of regulatory compliance expert services with insight, hindsight, and also the apparent advantage of our breadth and depth of data and regulatory compliance consulting. We offer the subsequent pharma consulting regulatory affairs companies for pharmaceutical organizations.
We understand the complexities of running a existence science business enterprise and have areas of experience that include every single side of R&D, functions, regulatory affairs, high-quality, and manufacturing.
Our customers are extremely innovative biopharmaceutical corporations executing extraordinary points. It’s awesome and often pretty complex science, and we’ve positioned ourselves proper in the midst of the motion, supporting therapeutic parts exactly where pioneers are carrying out the most fun perform.
Besides your published food stuff security & good quality method, every one of our consumers receives use of a package of worker food items security coaching videos, quizzes, and coaching logs that aren't publicly accessible at no extra cost in both equally English and Spanish.
This expertise allowed Ana to get an in-depth knowledge of the regulatory authorities’ anticipations and a comprehensive expertise in the EU and US GMP polices. She’s also carried out GMP inspections to 3rd party nations around the world on EMA’s behalf.
No matter your next task, our GMP consultants function carefully with our Architects, Engineers, Researchers and ex check here production employees that will help style and design your next undertaking, we routinely function with exterior contractors, equipment suppliers and builders.
We can easily for that reason provide you with this consulting assistance in each manner normal in the market. The design critique can frequently be performed without having a corresponding on-web-site existence, entirely depending on the technical documentation about the general and detailed organizing of an set up.
Through your no cost GMP consultation, you’ll find out what the requirements are for receiving Qualified, the amount of it fees without having concealed service fees, how much time it will require, And just how our procedure works to guarantee you move your GMP certification audit on the primary attempt.
Examine our trends report from a number of years back again to critique critical pharma criteria that remain at Participate in from the sector.
The related supervisory authority checks the legally compliant structure of the QMS and can only grant your company a permission to the activity in dilemma if all procedures are described in compliance with the laws.
Through mock inspections we’ll Check out that each one is accurately, and concentrate on remediation as desired.
This incorporates by read more way of example, qualification, validation and deviation or improve administration. The Gap Assessment can be an active comparison from the proven present-day condition While using the demands specified by community or Worldwide GMP restrictions.