We received by way of our audit and we are incredibly happy to acquire obtained a ninety nine.37% rating. I have been Doing work for many, a few years and it is extremely refreshing to work with another person which can be so Expert and do the things they say they can do and continue to deal with people with kindness.
We realize the various issues and problems you facial area with your approach to acquiring GMP compliance inside the pharmaceutical, biotechnology, ATMP and health-related unit manufacturing industries - and we create simple, achievable and cost-successful answers for you personally.
We guarantee coherent strategies are connected to growth and industrial objectives, aligned with the newest Concepts and emerging systems and regulatory specifications. Designed upon a vocation’s worth of manufacturing and improvement encounter, we are able to support you in enabling your solutions to development to marketplace quicker that has a ‘suitable to start with time’ solution.
Rivals drive just about every perceived advantage. The stakes are superior, though the methods are below. We equip you with the applications and skills to outperform the competition, develop your earnings and win regularly.
Our pharmaceutical consulting Experts will produce a tailored strategy dependant upon your product and company’s unique wants. Our regulatory compliance shoppers include:
“Kellerman Consulting was Qualified, successful, and continues to show their assistance and steering even following the GMP audit”.
An on the web and offline monitoring of QMS at web more info site is executed by our industry experts by means of high-quality matrices. This Software is noticeably handy for pharma corporations to remain in point out of compliance and all time Prepared for regulatory inspections.
Legislation companies seeking pharmaceutical consulting agency skills in the remediation of warning letters, consent decrees, 483’s or import bans
In addition to parenterals PJC Pharma Consulting can present a variety of guidance for other dosage forms, from applicant range by to NDA/MAA submissions, both equally For brand new chemical entities and product or service line extensions (PLEs) of a variety of oral dosage formulations: Tableting
Which has a GMP specialist on board, your Firm can concentrate on its Main operations when ensuring compliance is meticulously maintained.
- 360 diploma audit technique To judge the capabilities and high-quality website methods of suppliers and out-sourcing partners
We now have accomplished a lot more than seven-hundred+ Vendor/Provider Qualification audits. Regionally based consultants in wider geography so helpful quality of work with no language barrier and journey limits.
It’s a pharma consultancy Launched by regulatory compliance executives in the pharmaceutical field. Every single pharmaceutical marketplace consultant around the Regulatory Compliance Associates staff is aware the exceptional inner workings on the regulatory process.
Sub-populace Optimization and Modeling Solution Use device Understanding-pushed analytics to aid establish promising client subgroups, likely preserving your financial commitment and ensuring useful therapies reach individuals. Relevant remedies