Ana’s integrated vision of Pharmaceutical Quality Methods serves her properly in collaborating with interior and external prospects to stability compliance with sensible, fit to be used answers.
Shift your organization ahead whilst protecting a ongoing and total point out of regulatory compliance. From regulatory observation responses to inspection readiness, our big personnel of compliance specialists can tackle practically any regulatory obstacle.
As your associate, we can easily negotiate the possible evaluation minefield of regulatory compliance services with Perception, hindsight, and the crystal clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs products and services for pharmaceutical firms.
Elevate business styles with precision and pace employing AI-pushed analytics and technologies that illuminate concealed insights in data.
Consulting service: Our expert will Examine your specific case and give you a professional evaluation.
The definition in the scope to get analyzed would be the responsibility of the consumer. In case of detailed hole analyses, the GMP/GxP specialist executing the Assessment could propose clarification of interfaces or transitions between personal analyses.
Kellerman Consulting staff users are kept up-to-date on each individual challenge, to make sure that Anybody of our consultants can certainly move in at check here any moment to supply you with the dependability and responsiveness your challenge deserves.
Alex has held administration stage roles in High-quality Assurance, making certain solution excellent & regulatory compliance, in click here addition to Senior Technological Supervisor positions responsible for CMO administration, oversight and tech-transfer of pharmaceutical products and solutions. This experience equips him nicely in evaluating manufacturing devices for early stage products and solutions, as well as late phase and commercial products and solutions for EU and US markets.
Would you currently Possess a requirement and wish to fill a leadership posture on an interim foundation? Question us about suited profiles for the temporary vacancy.
During your totally free GMP session, you’ll discover what the necessities are for receiving Licensed, exactly how much it charges without having hidden charges, just how long it will take, And the way our system operates to assure you move your GMP certification audit on the very first try.
ADAMAS’s Very good Producing Follow (GMP) authorities can perform to evaluate devices at your pharmaceutical, biotechnology, or clinical unit Business or at your seller internet sites to ascertain if the systems set up are ample to satisfy your manufacturing demands and the current regulatory standards.
We've got done greater than 700+ Vendor/Provider Qualification audits. Regionally centered consultants in broader geography so effective high quality of work without having language barrier and travel limitations.
It’s a pharma consultancy Launched by regulatory compliance executives in the pharmaceutical marketplace. Just about every pharmaceutical marketplace consultant on the Regulatory Compliance Associates group is aware of the distinctive internal workings on the regulatory course of action.
Our built-in consulting strategy can also give both of those program- and analyze-level system together with practical asset valuation. Learn more about our abilities in: