“Kellerman Consulting acted for a trainer for our new QC hire, so we benefited from that in addition to the profitable preparing for that SQF audit. We obtained a 98% within the audit. That ought to talk for alone.
Hole analysis is usually a classical consulting Instrument to align the current Along with the target position. It relates possibly to all the GMP procedure of a regulated company or to person subareas.
Because of our comprehensive team of consultants, we tend to be capable to carry out the asked for Hole Assessment within a well timed manner.
We understand the complexities of operating a lifetime science enterprise and have parts of experience that include just about every aspect of R&D, operations, regulatory affairs, high quality, and producing.
Our pharmaceutical consulting Experts will create a custom-made solution dependant upon your product and corporation’s particular person requires. Our regulatory compliance clientele include:
Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting businesses with field authorities skilled in complexities from the pharmaceutical and biopharmaceutical GMP consultancy industries.
Our Operational Excellence in Producing tactic helps businesses to overcome worries by developing and deploying prime-tier business enterprise expertise. For a lean producing marketing consultant, we Perform a pivotal role in thriving small business transformations.
This practical expertise, coupled with our extensive knowledge of regional and international restrictions, positions us as an unmatched asset to any Group looking for GMP compliance.
Continue to be ahead within a fast altering planet. Subscribe to Bain Insights, our monthly think about the vital problems facing world wide organizations.
- We ensure that your plant web page satisfies your small business aims even though getting totally compliant with the newest Excellent Producing Observe laws and requirements.
R & D Presents intellectual residence and regulatory assistance to create a sustainable, compliant product to make benefit.
Our good quality, production, CAPA, and supplier high-quality authorities conduct in depth system evaluations and analyses to ensure all compliance gaps are shut irrespective of in which They might be.
Have to have to build or increase your Quality Assurance group with major expertise? We assist Countless everyday living science providers outsource their QA assignments and fill specialized roles by way of easy staff members augmentation and recruitment.
This contains as an example, qualification, validation and deviation or adjust administration. The Hole Evaluation is really an active comparison with click here the founded existing point out Using the needs specified by area or Worldwide GMP laws.