At Regulatory Compliance Associates, we offer the pharma consulting knowledge and pharma consultants important to information you from the excellent compliance method.

The rules system bordering pharmaceutical companies is often difficult for even one of the most seasoned sector veteran to know. Only one misstep could signify considerable and Long lasting consequences for your organization.

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Regulatory Compliance Associates pharma regulatory consultants will produce a comprehensive evidence e book of documented proof demonstrating the corrective motion taken to remediate non-compliant troubles.

Our staff of skilled regulatory experts can generate the nonclinical, scientific, and CMC sections in CTD and conventional format for your new drug and biologic programs.

We understand the complexities of jogging a lifestyle science enterprise and have places of experience that include each and every aspect of R&D, operations, regulatory affairs, high-quality, and manufacturing.

An on the web and offline monitoring of QMS at web page is executed by our industry experts by means of high quality matrices. This Device is considerably practical for pharma corporations to remain in condition of compliance and all time Completely ready for regulatory inspections.

Legislation corporations searching for pharmaceutical consulting company know-how within the remediation of warning letters, consent decrees, 483’s or import bans

The EY R&D Workbench for Pharma is a unique tech Answer for efficient task preparing administration, workflow and concern and question monitoring while in the R&D setting.

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Laura with Kellerman Consulting is just wonderful. She is very valuable, here straightforward to work with and bought us as a result more info of our GMP audit which has a much better score than we predicted. Also, the Firm of all the paperwork Kellerman Consulting provided us with is superb.

STRATEGIC DRUG DEVELOPMENT Generate system by professional regulatory Perception and advice Sector-foremost therapeutic and functional space specialists aid clientele glean suitable regulatory insights from entire world-course info, enabling true-time perseverance and analysis of time, cost and hazard.

As your companions, Regulatory Compliance Associates can negotiate the opportunity minefield of regulatory compliance and regulatory research with insight, hindsight, as well as apparent advantage of our special know-how and knowledge.

Previous to the introduction of medicinal solutions to the market, the rules of Good Exercise (GxP) ought to be followed for the duration of generation and development.