Do you need aid or tips on one or more of these subjects? Our skilled gurus will accelerate the entry of one's products into your pharmaceutical/biotech market.
You take advantage of the guidance of GMP consultants who overview every single task as a team. The co-founders of Kellerman Consulting are involved with Every job at each and every phase to be sure that we are delivering on our dedication to our purchasers.
As your spouse, we could negotiate the opportunity assessment minefield of regulatory compliance solutions with insight, hindsight, and also the distinct advantage of our breadth and depth of information and regulatory compliance consulting. We provide the following pharma consulting regulatory affairs providers for pharmaceutical corporations.
Doing work with the Original improvement activity phase, applicant variety, as a result of scale up and complex transfer in the factory community, our expertise in validation and microbial evaluation with the producing method, hazard assessments and scientific demo designs is usually invaluable when placed on your portfolio.
Tetrahedron helped the business to show around the operations of the organization website within an sector which resistant to adjust. Next effects have been attained:-
How do we get it done? By Operating closely with your staff and by subsequent our repeatable and dependable course of action.
Considerable planning of instructions: Our industry experts build comprehensive Guidance for website all vital excellent assurance equipment.
Regulation firms in search of pharmaceutical consulting agency know-how while in the remediation of warning letters, consent decrees, 483’s or import bans
Having hosted FDA meetings, FDA pre-acceptance inspections and MHRA inspections, We have now many years of experience top trans-national groups based in Japan, Europe and The usa of The us and various international marketplaces for growth of items for that Japanese and worldwide business marketplaces.
Empowering clients to personalize their Health care and connecting them to caregivers has the opportunity to change the treatment delivery paradigm. IQVIA and Apple are collaborating to deliver this enjoyable way forward for individualized treatment directly to products people already have and use.
Study our trends report from the few years back to overview important pharma factors that are still at Enjoy while in the business.
The conventional scope of the style and design assessment could range between viewing an individual area or an entire facility. Other than GMP compliance the output capability and prospects products spectrum Enjoy a substantial job while in the analysis course of action.
Through mock inspections we’ll Test that every one is correctly, and goal remediation as necessary.
We can present GMP products and services for unique market methods on your difficulties and also detailed packages that include all GMP specifications arising in the context of pharmaceutical producing pursuits.