Our pharmaceutical consulting workforce is prepared that can help your business experience a few of nowadays’s most urgent troubles.
Move your Group ahead whilst protecting a ongoing and full state of regulatory compliance. From regulatory observation responses to inspection readiness, our huge staff members of compliance experts can deal with virtually any regulatory obstacle.
GMP consultants with QA experience understand how Every single Section from the Corporation interacts While using the manufacturing processes and methods. QA industry experts have a complete photograph in your mind when coming up with a quality management system and so are extremely professional in federal, nearby, and Experienced expectations.
Therefore, all provider qualification actions add to the overall objectives of medicinal product or service basic safety, efficiency and compliance.
Kellerman Consulting held my hand every single move of the best way (and believe in me I essential it)! Kellerman Consulting got me via all of my approvals by having an easy to adhere to HACCP approach that appeased a USDA regional supervisor.
Regulatory Compliance Associates Good quality consulting features assessments, technique, implementations, team augmentations, and identification of high quality metrics to make certain steady enhancement. Our pharma consultants have an understanding of the strategic wondering required to align your small business demands and objectives.
As Section of possibility management and on The idea of regulatory specifications, audits have to be completed by sufficiently experienced staff from your company or by 3rd get-togethers on website at the provider's premises or by means of questionnaire audits, with regards to the criticality of the goods/companies.
Providers Providers EY aids shoppers develop extensive-expression value for all stakeholders. Enabled by information and technologies, our companies and methods supply belief through assurance and assistance shoppers transform, develop and operate. Approach by EY-Parthenon
Kellerman Consulting has supported many purchasers nationwide to efficiently move their regulatory inspections as well as their GMP and cGMP certification audits.
We assistance web-site for successfully passing inspections and layout post-inspections remediation programs to determine & improve GMP compliance and preserve acceptance to your merchandise with Pharmexpert's personalized and value-powerful courses for Top quality Management for Pharmaceuticals, Bio-Pharma and MD.
Laura with Kellerman Consulting is just great. She is extremely useful, effortless to work with and obtained us through our GMP audit which has a significantly better score than we anticipated. Also, the organization of each of the paperwork Kellerman Consulting delivered us with is great.
Consultants prepare the room get more info reserve, which includes appropriate and distinct get more info information about Each individual area in particular.
On-connect with serious-time assistance for the duration of your GMP audit and ongoing support once the audit right up until you're Qualified, regardless of the.
The restrictions process encompassing pharmaceutical corporations is usually tricky for even by far the most expert business veteran to be familiar with. Just one misstep could suggest important and lasting effects for your organization.