“Kellerman Consulting acted as being a trainer for our new QC employ, so we benefited from that plus the effective planning to the SQF audit. We got a ninety eight% within the audit. That ought to communicate for alone.
Transfer your Firm ahead while protecting a continuous and entire point out of regulatory compliance. From regulatory observation responses to inspection readiness, our significant employees of compliance professionals can deal with almost any regulatory obstacle.
- And when on-website visits aren't feasible, our flexible shipping and delivery model makes it possible for us to ensure small business continuity and the lowest achievable influence on all auditing operations, we carry out audits remotely by way of documentation evaluations and SME discussions According to Pharmexpert methodology. And When onsite audit feasible, We strategy for onsite audit.
Hence, all supplier qualification steps add to the general objectives of medicinal product basic safety, effectiveness and compliance.
Generally the design assessment put in place is ready by a single GMP marketing consultant. The documents then are checked and evaluated in presentation manner by two or a few specialists.
Ongoing assist: Our dedication towards your Group doesn’t conclusion Along with the supply of a consultation company. We believe in forging lasting partnerships, and therefore, we offer ongoing assist and coaching to ensure your prolonged-time period GMP compliance.
Selecting a GMP expert is actually a vital conclusion that could form your compliance journey and affect the overall success of your enterprise.
With greater than 20 years of experience with FDA, Health and fitness Canada, EU and website international regulatory agencies around the globe, Regulatory Compliance Associates® presents top pharmaceutical consultants. We’re on the list of couple pharma consulting providers that will help you navigate the difficulties connected with industry rules.
I remarkably advise dealing with Kellerman Consulting. Working with Brian Kellerman place me at relieve. He’s quite useful, affected person, and took enough time to wander me by means of the process. An throughout very good man! If at any time I would like the expert services this company delivers I’ll glimpse no additional.
Acquiring IQVIA’s positions on important trends within the pharma and daily life sciences industries, using a center on EMEA.
EY is a global chief in assurance, consulting, approach and transactions, and tax solutions. The insights and quality providers we produce support Develop have faith in and self-assurance inside the funds marketplaces As well as in economies the globe read more about.
We've done in excess of seven hundred+ Seller/Supplier Qualification audits. Domestically dependent consultants in wider geography so successful high-quality of work without language barrier and journey constraints.
- The audit report shall be then accessible inside our Audit report databases which can be accessible to any within your purchasers. We will attain permission of your supplier in advance of sharing experiences into the consumers.
We are able to give GMP solutions for personal area of interest alternatives in your challenges in addition to thorough packages that include all GMP specifications arising inside the context of pharmaceutical manufacturing routines.