An Unbiased View of pharma consultancy
An Unbiased View of pharma consultancy
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During the product or service life cycle of the medicinal product, top quality requirements maximize constantly from research and progress through the different clinical phases to industry maturity.
“We partnered with Kellerman Consulting pretty early on inside the SQF certification system, and by relying on their knowledge and methodical method of collecting, compiling, and Arranging the necessary documentation, we were being thriving in gaining our certification.
Law firms trying to get pharmaceutical consulting business know-how during the remediation of warning letters, consent decrees, 483’s or import bans
We recognize the complexities of functioning a existence science small business and possess parts of experience which include just about every aspect of R&D, operations, regulatory affairs, high quality, and producing.
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Our deep roots in strategy combined with our proprietary investigate, cross-purposeful healthcare and lifestyle sciences skills, and relentless purchaser centricity assist you corral seemingly disparate selections right into a coherent, orchestrated plan of assault. Our pharmaceuticals and biotech consulting groups have deep working experience helping clients lower complexity, master Marketplace four.
From R&D to supply chain and functions to every side of commercialization, pharma and biotech providers need to execute flawlessly across all dimensions whenever they hope to earn.
Alex has held administration degree roles in Excellent Assurance, ensuring item top quality & regulatory compliance, along with Senior Technical Supervisor positions chargeable for CMO management, oversight and tech-transfer of pharmaceutical merchandise. This practical experience equips him very well in analyzing production systems for early stage products and solutions, in addition to late section and commercial goods for EU and US marketplaces.
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With us, you keep away from delays in the current market entry as a result of a lack of GMP compliance and transfer your small business idea forward as quickly as you can.
Laura with Kellerman Consulting is simply fantastic. She is incredibly helpful, quick to work with and obtained us by means of our GMP audit by using a much better rating than we predicted. Also, the Corporation of the many click here documents Kellerman Consulting presented us with is great.
We have now done greater than 700+ Vendor/Supplier Qualification audits. Regionally based mostly consultants in wider geography so efficient excellent of labor without the need of language barrier and journey limits.
Very good Production Tactics (GMPs) can also be often called prerequisite applications, or food safety and excellent fundamentals. These are definitely the positioning and firm precise guidelines and everyday things to do place into place to continue to keep products Risk-free. GMPs may very well be prepared down or communicated verbally and so are frequently enforced by way of High quality Assurance or administration personnel.
Regulatory more info Compliance Associates High-quality consulting includes assessments, tactic, implementations, personnel augmentations, and identification of quality metrics to guarantee continuous advancement. Our pharma consultants comprehend the strategic wondering necessary to align your business wants and plans.