- Joining our IGAP software/ Audit report library is absolutely free for suppliers/manufacture. Our skilled and certified auditor will complete entire web page audit of supplier masking massive number of molecules/solutions (if not by now performed) without any charge to supplier and in depth audit report shall be ready.
We will critique your documentation and pay a visit to your facility, recognize gaps as part of your existing software and facility functions, and we will let you fill Individuals gaps so that you can move your audit.
The good GMP consultants may possibly propose modern-day technologies and verified processes to obtain greater high quality and much more efficient procedures. Using the services of FDA GMP consultants can stop highly-priced mistakes For numerous brands.
The rules system surrounding pharmaceutical firms is usually tricky for even probably the most skilled market veteran to comprehend. Just one misstep could signify considerable and lasting implications for your company.
Kellerman Consulting held my hand just about every phase of the best way (and have faith in me I needed it)! Kellerman Consulting got me via all of my approvals using an very easy to follow HACCP approach that appeased a USDA regional supervisor.
Christina Sanchez Miller, MPH has more than 20 years of administration, biologics, high quality assurance and study working experience in the health care area. She is a published author in scientific textbooks, papers and has introduced at various Global conferences.
- And when on-internet site visits are not feasible, our versatile shipping model makes it possible for us to guarantee business enterprise continuity and the bottom achievable effect on all auditing operations, we accomplish audits remotely by means of documentation testimonials and SME conversations According to Pharmexpert methodology. And When read more onsite audit feasible, We system for read more onsite audit.
Regulation companies in search of pharmaceutical consulting organization abilities within the remediation of warning letters, consent decrees, 483’s or import bans
Having hosted FDA meetings, FDA pre-approval inspections and MHRA inspections, We've got many years of encounter leading trans-nationwide teams located in Japan, Europe and the United States of The united states along with other Global marketplaces for growth of solutions for that Japanese and throughout the world business marketplaces.
With us, you prevent delays with your sector entry on account of a lack of GMP compliance and shift your business strategy forward as immediately as possible.
Read our trends report from the few years again to review critical pharma criteria that are still at Participate in within the industry.
The related supervisory authority checks the legally compliant design and style of your QMS and might only grant your business a permission for the activity in question if all procedures are described in compliance Using the regulations.
In management consulting area, IT consultants aid consumers address company and operational troubles through the implementation of data Engineering
Establishing IQVIA’s positions on important trends within the pharma and daily life sciences industries, by using a focus on EMEA.