Irrespective of whether you’re while in the item scheduling, enhancement or pharmaceutical lifecycle management phase or need a remediation strategy for your compliance crisis, Regulatory Compliance Associates will tutorial you thru every single pharmaceutical consulting action of the regulatory method.
“We partnered with Kellerman Consulting incredibly early on within the SQF certification approach, and by relying on their skills and methodical approach to collecting, compiling, and Arranging the demanded documentation, we were being productive in gaining our certification.
- When report required on urgent basis to help the provision, regulatory submissions and many others., When production web page can’t accommodate the audit due to active program, When journey restriction; Sponsor could get Added benefits by getting our IGAP reviews from our report database, In addition our shoppers only commit a small portion of the costs usually related to conducting a supplier audit.
Doing work in the First improvement exercise phase, prospect choice, by way of scale up and complex transfer in to the manufacturing unit community, our skills in validation and microbial assessment with the production method, chance assessments and medical demo styles may be invaluable when placed on your portfolio.
Our satisfaction lies not merely within the variety of products and services we offer but also from the folks who deliver these expert services. A number of our GMP consultants are seasoned industry experts who definitely have served as GMP inspectors and have a rich background of navigating the complicated environment of pharmaceutical rules.
How can we get it done? By working closely with the staff and by following our repeatable and trustworthy approach.
plan were being good. In the audit it gave me self-assurance understanding we had almost everything consistent with BRCGS requirements.
Biopharma Launch Edge gives a comprehensive choice of start services created to support supply groundbreaking results, by supplying a faster, less complicated plus much more effective launch system.
We've an A score with BRCGS and I attribute that to Brian Kellerman and Kellerman Consulting for every little thing they may have accomplished to aid our small business to get the certification. Their Preliminary assessment of our organization, the documents, and information supplied to create our
I couldn’t have asked for a website better business that can help us work on our certification. They had been practical, instructional, and got our application efficiently converted with very check here clear professionalism.
Regardless of whether you’re inside the products scheduling, improvement or pharmaceutical lifecycle management phase or need a remediation method for your compliance disaster, Regulatory Compliance Associates will tutorial you thru each individual pharmaceutical consulting step from the regulatory system.
We’ll evaluate your unique approach and desires. Our crew will write your GMP application custom made to the operation. We’ll educate both you and your group on how to follow all of the foodstuff security & high quality strategies.
You could commission us With all the comprehensive conception and document generation for your QMS or have our specialists accompany or implement the processing of person focal details.
This consists of as an example, qualification, validation and deviation or improve administration. The Hole Evaluation is undoubtedly an Lively comparison with the recognized present-day state Together with the specifications specified by regional or Global GMP rules.