Ana’s integrated vision of Pharmaceutical Top quality Programs serves her perfectly in collaborating with inner and exterior prospects to equilibrium compliance with functional, fit for use methods.
In spite of everything, it will just be too cumbersome and high priced to create any sizeable modifications to the facility layout or development just after it's done and happens to be operational if errors are located or even worse, regulatory companies deny its acceptance for production.
Legislation firms searching for pharmaceutical consulting agency knowledge inside the remediation of warning letters, consent decrees, 483’s or import bans
At Regulatory Compliance Associates, we offer the pharma consulting working experience and pharma consultants essential to manual you throughout the excellent compliance system.
Consulting services: Our advisor will Appraise your individual scenario and give you an expert evaluation.
“Kellerman Consulting was Experienced, economical, and continues to show their help and steering even once the GMP audit”.
This expertise allowed Ana to get an in-depth comprehension of the regulatory authorities’ expectations and an extensive understanding of the EU and US GMP regulations. She’s also performed GMP inspections to third party nations around the world on EMA’s behalf.
uncommon diseasecell & gene therapyoncology & hematologydermatologymedtechneurosciencepediatricsanalgesiawomen’s wellness Major the way in which
Owning hosted FDA conferences, website FDA pre-approval inspections and MHRA inspections, We now have many years of encounter primary trans-national teams based in Japan, Europe and America of The united states and various Global markets for development of products for the Japanese and globally professional marketplaces.
- We be sure that your plant web site satisfies your small business targets even though getting fully compliant with the latest Great Producing Exercise rules and criteria.
A crew of lasting GMP consultants, specialized in different fields of competence, supports you in your duties and problems with knowledge and foresight.
Our good quality, production, CAPA, and supplier top quality professionals conduct complete system evaluations and analyses to be certain all compliance gaps are shut no matter wherever They might be.
A GMP guide delivers the professional advice required to navigate the complexities of GMP compliance. Their in depth expertise in neighborhood and international regulations, business finest procedures, and the most up-to-date updates in the sphere equips your organization with the instruments to fulfill and exceed regulatory standards.
“They're so Expert and it was just a real satisfaction Functioning by means of every little thing. I would Certainly recommend Kellerman Consulting. I have already got. When folks ask me with regards here to the SQF consulting method, I would not wait to convey," definitely call Kellerman Consulting'' ” .