Do you want assist or information on a number of of these subject areas? Our professional industry experts will accelerate the entry of the products into the pharmaceutical/biotech current market.
We fully grasp the diverse challenges and worries you confront on the way to acquiring GMP compliance during the pharmaceutical, biotechnology, ATMP and health care machine production industries - and we produce realistic, achievable and value-productive methods for you personally.
A lot of our all-natural experts and engineers are knowledgeable about currently being in management positions and, if expected, also inside of your business.
It’s a pharma consultancy Established by regulatory compliance executives in the pharmaceutical business. Every pharmaceutical industry guide around the Regulatory Compliance Associates crew is aware of the exceptional internal workings in the regulatory procedure.
Our mission should be to accelerate innovation to get a healthier environment. Alongside one another, we could remedy consumer troubles and strengthen individual lives.
Elevate business designs with precision and speed applying AI-pushed analytics and engineering that illuminate hidden insights in info.
Commissioning, Qualification & Validation We get the job done with our shoppers to establish scalable useful resource plans to help validation endeavours throughout the job lifecycle. Whether it is drafting protocols to execution and compilation of click here data packs, our sources have you covered.
Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting providers with marketplace industry experts seasoned in complexities on the pharmaceutical and here biopharmaceutical industries.
Kellerman Consulting has supported numerous clients nationwide to correctly go their regulatory inspections and their GMP and cGMP certification audits.
Having a GMP guide on board, your Business can target its core operations though making certain compliance is meticulously preserved.
- 360 diploma audit solution To judge the abilities and quality programs of suppliers and out-sourcing associates
- Signing up for our IGAP plan/ Audit report library is totally free for suppliers/manufacture. Our expert and qualified auditor will perform whole web site audit of provider covering huge quantity of molecules/solutions (if not now carried out) without any cost to provider and specific audit report shall be organized.
On-connect with actual-time assist during your GMP audit and ongoing help following the audit until you are Licensed, whatever.
We'll produce your provider approval method, do the job along with you to definitely put into action it, and practice you to help keep it managing.