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“We partnered with Kellerman Consulting extremely early on inside the SQF certification process, and by depending on their abilities and methodical method of amassing, compiling, and organizing the required documentation, we were effective in attaining our certification.
We make certain coherent options are linked to progress and industrial aims, aligned with the latest Tips and emerging systems and regulatory demands. Built upon a occupation’s really worth of producing and growth practical experience, we are able to help you in enabling your items to development to market place quicker by using a ‘suitable 1st time’ tactic.
The regulations system encompassing pharmaceutical providers may be challenging for even essentially the most expert business veteran to comprehend. Just one misstep could indicate sizeable and lasting effects for your small business.
Our mission should be to accelerate innovation for any healthier entire world. Together, we could fix buyer issues and enhance affected person lives.
Conventional Operating Strategies (SOPs) and also all supplementary quality management files (QMS) needs to be optimally tailored to one another and to the corporation's Business to empower economical and faultless do the job in accordance Together with the respective rules.
Comprehensive planning of Recommendations: Our professionals create extensive Recommendations for all vital top quality assurance resources.
Services Services EY aids consumers build lengthy-expression worth for all stakeholders. Enabled by knowledge and technological know-how, our solutions and solutions deliver rely on by way of assurance and aid purchasers rework, develop and run. Technique by EY-Parthenon
Besides parenterals PJC Pharma Consulting can give an array of aid for other dosage types, from candidate variety as a result of to get more info NDA/MAA submissions, the two For brand spanking new chemical entities and solution line extensions (PLEs) of many oral dosage formulations: Tableting
Building IQVIA’s positions on vital trends during the pharma and lifestyle sciences industries, which has a focus on EMEA.
As the check here marketplace grows bigger and competitive, the war for quality expertise is gaining momentum. This calls for Qualified experience in pinpointing, sourcing and engaging upcoming-All set expertise.
Producing IQVIA’s positions on essential tendencies inside the pharma and life sciences industries, that has a target EMEA.
As your companions, Regulatory Compliance Associates can negotiate the probable minefield of regulatory compliance and regulatory homework with insight, hindsight, plus the clear advantage of our distinctive knowledge and encounter.
This involves for instance, qualification, validation and deviation or adjust administration. The Gap analysis is surely an active comparison of your established latest condition with the needs specified by neighborhood or Intercontinental GMP rules.