Over the products lifestyle cycle of a medicinal products, quality specifications raise repeatedly from investigate and growth by means of different medical phases to marketplace maturity.
We'll overview your documentation and take a look at your facility, identify gaps as part of your existing program and facility functions, and we will help you fill those gaps so as to move your audit.
Proprietary talent array of previous FDA and field gurus amplified by a corporate tradition of responsiveness and execution. About Overview
We recognize the complexities of running a lifestyle science enterprise and have places of expertise which include each individual aspect of R&D, functions, regulatory affairs, quality, and production.
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“Kellerman Consulting was Specialist, efficient, and continues to show their guidance and advice even after the GMP audit”.
The QA Division is recognized for policing the controlled procedures for the business. They make certain compliance is met. To be able to perform while in the QA Division, someone demands thoroughness and attention to element. There is not any substitute for QA encounter.
Regulatory Compliance Associates pharma regulatory consultants will create a comprehensive proof book of documented proof demonstrating the corrective action taken to remediate non-compliant difficulties.
We try to help improve results and produce a healthier, much more sustainable world for people everywhere.
The medication and pharmaceuticals industry in India has emerged as one of the most important sectors, garnering a internet marketing development of 9.
Kellerman Consulting does an awesome position of consistently Conference prospects’ expectations and having time to understand the requirements of their exceptional shopper. Their assistance goes previously mentioned and outside of expectations.
Trust in our experience from obtaining helped our clientele pass hundreds of GMP audits. Our GMP consultants will manual your crew to success.
Need to click here have to build or augment your High quality Assurance workforce with top expertise? We aid 1000s of lifetime science corporations outsource their QA projects and fill more info specialized roles as a result of hassle-free team augmentation and recruitment.
Regulatory Compliance Associates High-quality consulting includes assessments, system, implementations, staff members augmentations, and identification of excellent metrics to ensure continuous enhancement. Our pharma consultants recognize the strategic thinking necessary to align your company requirements and ambitions.