We bought by means of our audit and we are incredibly very pleased to acquire obtained a 99.37% rating. I are actually Doing the job for many, a few years and it is very refreshing to operate with an individual that may be so professional and do whatever they say they may do and even now treat those with kindness.
We understand the numerous problems and worries you deal with on the way to achieving GMP compliance from the pharmaceutical, biotechnology, ATMP and health care product manufacturing industries - and we acquire practical, achievable and price-efficient answers for you personally.
- When report needed on urgent basis to assist the availability, regulatory submissions and so forth., When manufacturing web-site can’t accommodate the audit on account of occupied schedule, When journey restriction; Sponsor could get Gains by buying our IGAP experiences from our report databases, Additionally our shoppers only commit a little fraction of the costs usually connected with conducting a provider audit.
It’s a pharma consultancy Started by regulatory compliance executives with the pharmaceutical sector. Each individual pharmaceutical sector consultant over the Regulatory Compliance Associates group understands the unique inner workings of the regulatory approach.
Our pharmaceutical consulting Gurus will develop a tailored method determined by your products and business’s specific demands. Our regulatory compliance shoppers include things like:
Zero Impact: To create the generation method, item, setting pleasant and sufficient for social effectively becoming and sustainability with the setting.
This knowledge authorized Ana to realize an in-depth understanding of the regulatory authorities’ anticipations and an extensive understanding of the EU and US GMP polices. She’s also carried out GMP inspections to third party countries on EMA’s behalf.
Legislation companies in search of pharmaceutical consulting organization skills in the remediation of warning letters, consent decrees, 483’s or import bans
Trained dozens of pharmaceutical executives and leaders on how to successfully and compliantly use The brand new electronic Software to streamline workflows and vital procedures
Establishing IQVIA’s positions on crucial tendencies within the pharma and life sciences industries, having a deal with EMEA.
Laura with Kellerman Consulting is just terrific. She is rather beneficial, effortless here to operate with pharma consultants and received us by means of our GMP audit using a much better score than we predicted. Also, the Firm of all of the files Kellerman Consulting presented us with is great.
We’re medical growth professionals centered on assisting these days’s most modern biotech and specialty pharma organizations choose their ideal Thoughts from benchtop to bedside.
- 360 degree audit solution To judge the abilities and good quality systems of suppliers and out-sourcing companions
Clarkston supports late-stage medical corporations on their route to commercialization. Leveraging deep market skills and acknowledged functional and business enterprise approach Management that can help corporations transition from enhancement to commercialization, guaranteeing sustainable, lengthy-term growth.