About Knors Pharma
Integrated solutions for your company to comply with regulatory requirements.
We at KNORS Pharma Solutions LLP are a team of qualified and experienced pharma professionals working to provide solutions to the pharmaceutical industry. KNORS Pharma performs third party evaluation (Gap Analysis) of pharmaceutical manufacturer through its professionally designed tool for compliance level assessment. We help the pharma companies to implement comprehensive CAPA and prepare them for inspections from regulatory agencies like USFDA, MHRA, MFDS, EDQM. Our GMP auditors are qualified by international bodies like Intertek, France and Forum Auditorias, Spain. KNORS Pharma experts are professional trainers on cGMP and Pharmaceutical Quality Management Systems. KNORS provides support to the pharma industry in setting up new project with technology development, Technology optimization and technology transfers through validations.
Profile:-
> Established in 2016
> Registered as LLP Firm in Ministry of Corporate Affairs Government of India
> We are a pool of experts from different areas of pharmaceutical industry Manufacturing, Quality, Projects, Technology development and optimization, Drug Regulatory Affairs, Microbiology and Biotechnology
> Has performed more than 200 audits of manufacturers of APIs (Sterile and non-sterile), Drug Products (OSD, Injectables, Liquids and Ointments), Intermediates and Raw materials, Excipients, Cosmetic Ingredients and Biologicals
> IRCA Certified Lead Auditor
> We are qualified auditors for Intertek-France, AFA-Spain, PQE-Italy, Eurofins-France, BSI-United Kingdom (Indian Office) and Qualifyze- Germany
> Conducted facility assessment/gap analysis/due-diligence of the pharmaceutical manufacturers and prepared the site for successful regulatory inspections
> Submitted Drug Master Files and Medical Devices Files in MHRA, EDQM and USFDA in e-CTD