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Gap analysis is often a classical consulting Instrument to align the current While using the goal standing. It relates possibly to the whole GMP system of the controlled organization or to specific subareas.
Proprietary expertise variety of former FDA and marketplace specialists amplified by a corporate tradition of responsiveness and execution. About Overview
It’s a pharma consultancy Started by regulatory compliance executives through the pharmaceutical field. Each and every pharmaceutical market expert around the Regulatory Compliance Associates crew understands the unique interior workings from the regulatory method.
Our mission is always to accelerate innovation for just a healthier environment. With each other, we are able to fix customer worries and boost individual life.
Christina Sanchez Miller, MPH has around twenty years of management, biologics, good quality assurance and study expertise from the medical area. She is a printed author in scientific textbooks, papers and has introduced at various Worldwide conferences.
- And when on-website visits are not feasible, our flexible delivery design permits us to ensure enterprise continuity and the lowest doable effect on all auditing functions, we conduct audits remotely via documentation opinions and SME conversations as per Pharmexpert methodology. And When onsite audit possible, We plan for onsite audit.
Alex has held management stage roles in Quality Assurance, ensuring product or service high-quality & regulatory compliance, in addition to Senior Specialized Supervisor positions responsible for CMO administration, oversight and tech-transfer of pharmaceutical products. This working experience equips him very well in assessing manufacturing systems for early stage merchandise, along with late stage and business goods for EU and US markets.
Along with parenterals PJC Pharma Consulting can offer you a wide range of help for other dosage types, from prospect assortment via to NDA/MAA submissions, both of those For brand new chemical entities and products line extensions (PLEs) of numerous oral dosage formulations: Tableting
Throughout your no cost GMP consultation, you’ll discover what the requirements are for receiving Licensed, how much it fees without having hidden costs, how long it's going to take, And the way our process performs to guarantee you move your GMP certification audit on the main attempt.
We can fulfill clinical contracted and direct employ resource placement demands in a number of roles and functions together with,
Building IQVIA’s positions on important traits inside the pharma and lifestyle sciences industries, by using a give attention to click here EMEA.
Our Excellent system be sure that our clients get customized studies with regions most related get more info for their operations.
We can easily offer you GMP expert services for unique market answers on your issues as well as detailed deals that address all GMP demands arising during the context of pharmaceutical producing things to do.