At Regulatory Compliance Associates, we offer the pharma consulting practical experience and pharma consultants essential to guidebook you throughout the quality compliance method.
IQVIA is uniquely positioned to help hook up research with commercialization, so you're able to enhance your drug development system and target your investment on one of the most promising compounds.
GMP consultants with QA knowledge understand how Each and every Section while in the Corporation interacts With all the producing processes and systems. QA gurus have an entire photograph in mind when planning an excellent management method and are very experienced in federal, regional, and Specialist criteria.
It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical marketplace. Just about every pharmaceutical market guide on the Regulatory Compliance Associates team is aware the one of a kind inner workings on the regulatory system.
Kellerman Consulting held my hand each stage of the way (and trust me I wanted it)! Kellerman Consulting received me as a result of all of my approvals using an straightforward to observe HACCP plan that appeased a USDA regional supervisor.
We comprehend the complexities of operating a lifestyle science business and possess locations of experience that come with each facet of R&D, functions, regulatory affairs, excellent, and manufacturing.
A brand new breed of therapies is coming into clinical growth. Make sure that your method of drug progress is as revolutionary given that the compound you ought to deliver to sector.
We even have many inner compliance actions to make certain that knowledge is shielded from exterior threats, together with unbiased penetration testing.
How you can structure an air dealing with procedure Assembly the necessities of place cleanliness classification and environmental protection?
For the duration of your cost-free GMP session, you’ll learn what the necessities are for finding Qualified, the amount of it fees without concealed service fees, how long get more info it will take, And exactly how our method operates to guarantee you go your GMP certification audit on the initial test.
- We make certain that your plant web page meets your organization aims when getting totally compliant with the most recent Excellent Manufacturing Exercise regulations and specifications.
Expertise Administration Really helps to develop a human source foundation that can satisfy the complex and managerial need to have of growing enterprise ambitions.
Our Top quality procedure make sure our clients receive individualized reports with parts most suitable for their click here operations.
We develop custom made jobs in compliance with FDA / USDA regulatory needs and GMP certification demands for every company we serve.