A Secret Weapon For pharma consultants in India
A Secret Weapon For pharma consultants in India
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Whether you’re during the item arranging, growth or pharmaceutical lifecycle management phase or have to have a remediation method to get a compliance disaster, Regulatory Compliance Associates will information you thru each pharmaceutical consulting move on the regulatory system.
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We enable 1000s of corporations, together with 17 of the top 25 global pharmaceutical, biotech, and professional medical gadget corporations, link with the professionals they need from the exceptional workforce product.
Thus, all provider qualification actions contribute to the general aims of medicinal products safety, performance and compliance.
Kellerman Consulting held my hand each stage of how (and believe in me I desired it)! Kellerman Consulting bought me through all of my approvals with an straightforward to comply with HACCP strategy that appeased a USDA regional supervisor.
Unparalleled know-how: Our consultants have extensive field experience and an insider’s point of view from their time as GMP inspectors. They have stood on either side of your GMP compliance equation, giving them with a singular knowing that informs just about every service we offer.
We create exceptional leaders who group to provide on our promises to all of our stakeholders. In so undertaking, we Participate in a important purpose in building a better Functioning earth for our people, for our clientele and for our communities.
Alex has held management amount roles in High quality Assurance, ensuring products top quality & regulatory compliance, along with Senior Specialized Supervisor positions liable for CMO administration, oversight and tech-transfer of pharmaceutical merchandise. This experience equips him well in assessing producing devices for early section products, in addition to late phase and professional goods for EU and US markets.
Besides parenterals PJC Pharma Consulting can give a wide range of help for other dosage types, click here from applicant assortment through to NDA/MAA submissions, both equally For brand new chemical entities and product or service line extensions (PLEs) of a number of oral dosage formulations: Tableting
That has a GMP expert on board, your Business can deal with its Main operations when making certain compliance is meticulously managed.
ADAMAS’s Fantastic Manufacturing Exercise (GMP) specialists can function To judge units at your pharmaceutical, biotechnology, or healthcare product Corporation or at your vendor web sites to find out if the units in place are enough to meet your manufacturing desires and The existing regulatory benchmarks.
The appropriate supervisory authority checks the lawfully compliant style of your QMS and can only grant your company a authorization for your action in concern if all processes are explained in compliance Together with the polices.
Our Excellent method be sure that our clientele acquire customized stories with locations most relevant for their functions.
“They are so Experienced and it absolutely was just a real enjoyment working by way of every little thing. I'd Totally endorse Kellerman Consulting. I have already got. When people ask me concerning the SQF consulting procedure, I check here would not be reluctant to convey," surely get in touch with Kellerman Consulting'' ” .