Ana’s built-in eyesight of Pharmaceutical Top quality Methods serves her well in collaborating with interior and external buyers to equilibrium compliance with functional, in good shape to be used options.
We will evaluation your documentation and take a look at your facility, determine gaps in the present application and facility operations, and we will help you fill Individuals gaps to be able to move your audit.
As your companion, we are able to negotiate the prospective evaluation minefield of regulatory compliance services with Perception, hindsight, plus the obvious benefit of our breadth and depth of data and regulatory compliance consulting. We provide the next pharma consulting regulatory affairs expert services for pharmaceutical firms.
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Operational Excellence Advisor & Lean Manufacturing Marketing consultant can assist you using a holistic approach to achieve the specified ambitions within your Corporation. Tetrahedron deploys various instruments and strategies, Individuals align the organization’s culture, help staff, and sustain all carried out initiatives.
Standard Operating Methods (SOPs) in addition to all supplementary high-quality administration files (QMS) need to be optimally tailored to one another and also to the organization's organization to allow efficient and faultless operate in accordance While using the respective rules.
“Larsen Packaging Products and solutions is appreciative to Kellerman website Consulting and our contact Tim Grady for helping us in obtaining our GMP certification. Tim walked this journey with us from beginning to end and was always accessible to answer any inquiries and support us in acquiring processes, forms, and many others.
Alex has held administration amount roles in High quality Assurance, guaranteeing solution top quality & regulatory compliance, and also Senior Specialized Supervisor positions chargeable for CMO management, oversight and tech-transfer of pharmaceutical products. This encounter equips him effectively in more info analyzing manufacturing methods for early phase solutions, and late period and commercial items for EU and US markets.
I really suggest working with Kellerman Consulting. Dealing with Brian Kellerman place me at ease. He’s really useful, affected person, and took the time to stroll me by the process. An all around very good guy! If at any time I want the products and services this company offers I’ll seem no further more.
Establishing IQVIA’s positions on key trends inside the pharma and lifestyle sciences industries, using a give attention to EMEA.
In case medicinal items shall be manufactured for any scientific trial, a manufacturing authorisation plus a corresponding GMP certificate are now essential for this purpose.1
Creating IQVIA’s positions on important developments inside the pharma and daily life sciences industries, using a target EMEA.
In administration consulting area, IT consultants aid consumers remedy business and operational problems from the implementation of Information Technologies
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