Ana’s integrated vision of Pharmaceutical Top quality Devices serves her very well in collaborating with interior and external shoppers to stability compliance with functional, suit to be used methods.

Gap Evaluation is usually a classical consulting Device to align The existing Using the focus on status. It relates possibly to your entire GMP system of the controlled enterprise or to unique subareas.

- And when on-site visits are certainly not possible, our flexible supply design makes it possible for us to guarantee company continuity and the lowest achievable effect on all auditing functions, we execute audits remotely via documentation evaluations and SME conversations According to Pharmexpert methodology. And When onsite audit possible, We program for onsite audit.

To start the Regulatory Compliance Associates scoping process nowadays, remember to enter your information inside the blue variety under and click on the submit button at The underside from the webpage.

Zero Shipping and delivery / Failure: To accomplish the process within the lead time with out failure in Stock time, WIP storage, Logistics Expense, and mapping with the steps a company usually takes to accomplish a specific process.

“Kellerman Consulting was Experienced, effective, and carries on to point out their assist and direction even after the GMP audit”.

We comprehend your merchandise and prepare the power in accordance with Intercontinental regulatory specifications. The GMP certification session consists of documentation and staff members teaching in addition to facility design.

We can easily develop uncomplicated engineering prototypes which have been tailor-made for your useful and placement requirements and advise Expense-efficient alternatives that adjust to regulatory specifications. The next venture definitions is going to be defined throughout essential engineering:

Being a Specific company each interim manager has personnel again up at Valicare GmbH Place of work, who's properly-educated about The present condition at The shopper-website, to make sure that he / she can exchange the interim supervisor with out a check here prolonged changeover interval, if this could be vital.

We help web page for properly passing inspections and check here design and style submit-inspections remediation programs to establish & upgrade GMP compliance and sustain approval for your personal solution with Pharmexpert's customized and cost-powerful systems for Top quality Administration for Pharmaceuticals, Bio-Pharma and MD.

Tim and Brian rallied about me and created positive I had been willing to satisfy the obstacle head on. From composing and examining paperwork, to educating an entire amateur, to accomplishing a mock audit ahead of time, the Kellerman staff created absolutely sure we have been Completely ready not only to go, but to score a 91 on our initially audit. I couldn't suggest them a lot more really”!

As an extension of your respective GMP Auditing workforce, we’re in the position to conduct audits in your behalf, using your established audit application or even the ADAMAS system, whichever will work greatest for your preferences.

Establishing IQVIA’s positions on essential developments within the pharma and life sciences industries, that has a target EMEA.

Our pharma consultants know how to spouse with govt, lawful, and communication groups. Each RCA pharma consulting Expert will establish a response which will be acknowledged via the regulatory agency and become realistic to execute.