The Definitive Guide to GMP consultancy
The Definitive Guide to GMP consultancy
Blog Article
Our pharmaceutical consulting group is ready to assist your company confront a few of now’s most urgent worries.
We comprehend the various troubles and challenges you face with your solution to attaining GMP compliance inside the pharmaceutical, biotechnology, ATMP and medical device manufacturing industries - and we build practical, achievable and price-powerful methods in your case.
Nevertheless these difficulties are exterior things can’t be managed by any business. The just one and only way to remain sustainable is by a structured Producing Excellence Strategy.
Kellerman Consulting’s GMP consultants give a created high quality & meals security guide that may be tailor-made in your products, approach and operation. We offer high quality consulting and foods safety schooling according to recent FDA regulatory demands and personalized to your GMP certification scheme that you will be wishing to have Licensed against.
Generally the design evaluate setup is prepared by a person GMP consultant. The files then are checked and evaluated in presentation method by two or a few gurus.
Examine marketing consultant CVs » Begin a advisor search » Be part of our consulting workforce. On the FDA Group, we are constantly seeking top talent to develop our network. If you can deliver expertise and new perspectives to our consulting group, we invite you to mail us your resume.
- And when on-web-site visits usually are not possible, our flexible supply model permits us to guarantee business enterprise continuity and the lowest attainable impact on all auditing functions, we complete audits remotely by using documentation evaluations and SME conversations as per Pharmexpert methodology. And When onsite audit feasible, We plan for onsite audit.
Specifically, the next factors has to be documented and ensured: description of the internal processes, the suitability of all premises and facilities, the conformity of products used, the qualification from the staff and the standard of external providers.
Don't just did our audit here rating mirror how excellent their method functions, but I also obtained so way more comprehension of SQF and confidence as an excellent Manager!”
Our gurus performs third party analysis and hole read more Evaluation by using a quantified tool to assess the organization’s condition of regulatory compliance. We enable the companies in developing CAPA for deficiencies lifted by regulatory inspections.
Laura with Kellerman Consulting is just marvelous. She is extremely helpful, quick to work with and received us via our GMP audit that has a significantly better score than we anticipated. Also, the Group of many of the documents Kellerman Consulting presented us with is excellent.
Our high-quality, production, CAPA, and provider high-quality professionals carry out thorough course of action testimonials and analyses to make certain all compliance gaps are shut irrespective of wherever They could be.
M&A Realize continuously increased returns with a scientific and repeatable approach to mergers and acquisitions
Tell us about your consulting requires and acquire the discussion started. Explain to us about your certain requires or simply indicate that you'd like a contact-back again to discuss your undertaking. We'll adhere to up in a single business enterprise day.