We presents turnkey high-quality answers and concentrates on featuring Remarkable Price efficiency, whilst sustaining greatest good quality specifications for our Clients.
IQVIA is uniquely positioned that can help hook up study with commercialization, so you can optimize your drug advancement strategy and focus your financial commitment on the most promising compounds.
We be certain coherent strategies are associated with progress and professional aims, aligned with the latest Thoughts and rising systems and regulatory prerequisites. Crafted on a vocation’s well worth of manufacturing and growth expertise, we can guide you in enabling your products and solutions to progress to marketplace faster which has a ‘ideal to start with time’ method.
The founding partners, whose unique biodata are presented on the web site independently, have a solid commitment to Integrity, High quality and Excellence and perform with their clientele to achieve the customer’s ambitions with total compliance and stringent adherence to the highest ethical standards inside of a time sure manner. We Are living upto our stated motto "EXPERIENCE, EXPERTISE, EXCELLENCE" in all our consulting engagements.
Kellerman Consulting held my hand each and every move of how (and have faith in me I necessary it)! Kellerman Consulting bought me via all of my approvals having an simple to stick to HACCP approach that appeased a USDA regional supervisor.
This is certainly what an average procedure looks like: The GMP advisor initially checks the company-precise documentation and generates a hole Investigation strategy. Based upon this hole analysis approach, the analysis on-web site are going to be carried out.
The QA Section is known for policing the regulated procedures for the corporate. They make sure compliance is fulfilled. To be able to do the job in the QA Division, someone demands thoroughness and a focus to depth. There is not any substitute for QA expertise.
Regulation firms trying to find pharmaceutical consulting organization abilities within the remediation of warning letters, consent decrees, 483’s or import bans
Besides click here parenterals PJC Pharma Consulting can offer a variety of support for other dosage varieties, from prospect range by to NDA/MAA submissions, both equally for new chemical entities and solution line extensions (PLEs) of several oral dosage formulations: Tableting
Our benefits-driven staff will publish and put into practice your GMP system, coach you and stay with you until you move your GMP consultants GMP certification audit.
Laura with Kellerman Consulting is simply great. She may be very helpful, easy to work with and got us by our GMP audit by using a far better score than we anticipated. Also, the Group of all the files Kellerman Consulting presented us with is excellent.
Our Top quality system make sure that our purchasers obtain personalised studies with places most relevant for their operations.
Need to have to construct or increase your Quality Assurance workforce with best expertise? We support 1000s of lifetime science organizations outsource their QA tasks and fill specialized roles as a result of easy workers augmentation and recruitment.
It’s a pharma consultancy Established by regulatory compliance executives with the pharmaceutical marketplace. Every single pharmaceutical industry marketing consultant around the Regulatory Compliance Associates team appreciates the unique internal workings with the regulatory procedure.