Our Qualifications

FMK got many honorary qualifications,including national high and new technology enterprise certification /ISO9001 quality management system certification/a number of computer software copyright registration certificates/ honest enterprises certificate and so on.

ISO9001 Certification

ISO9001 Certification

Software copyright

Software copyright

High Technology Enterprise

Medical Device Board of directors

Shandong medical device member unit

Lixin Enterprises

Our Business

Our services and businesses focus on the most directed problems and links of customers’ needs, t to help solve the substantive questions. Currently,we have served more than 100 customers, a large number of successful cases, enough to prove that we have the awareness and ability to effectively solve problems for customers.Through our efforts, we will effectively improve the quality management system and continuously optimize the quality management mode for you.

GMP Consulting Service
' According to the actual situation of pharmaceutical enterprises, we will provide annual or periodical GMP Consulting services and establish a customized quality management system.
The Third Party GMP Audit Service
' Finding out the problems through gap analysis and simulation audit, to implement rectification and continuously improve the quality management level
Drug Registration Service
' Providing drug registration requirement training, preparing ANDA /DMF documents according to international drug registration requirements, optimizing the registration process and accelerating the registration progress
Training Business
' Provide GMP training and customized training services for company,optimizing the training system and perfecting the training process
Validation Business
' Providing CSV, Plant/Facilities/Equipment Verification, reviewing the verification activities including plan/program/report,and putting forward the corrective suggestions
MAH Service
' Providing customized and one-stop service for Marketing Authorization Holder,giving technical support,achieving time saving/business accurate /service efficient and improve the official recognition.
Software Business
' From the perspective of customers, proposing the demand specification,according to computer system life cycle of GAMP5, Design and develop information software that meet the needs of pharmaceutical industry and the requirements of drug regulatory
Medical devices Consulting
' Registered Agent,Quality Management Consulting
HR services
' Focusing on providing talent recruitment, training, and management services for pharmaceutical companies, empowering human resource decision-making in enterprises

Why Choose Us

Though the rapid development of the pharmaceutical industry, what remains unchanged is our consistent rigorous attitude towards the quality of drugs and the lofty belief in quality work. As we move forward step by step, we do not change our original intention, to achieve the optimization of quality management with the most favorable price and the best service.

Our Customer
Our Customer
Our Customer
Our Customer

Our Customer

As the third party entrusted by Shandong Food and Drug Administration,inspected the pharmaceutical and medical device companies on compliance of GMP work.We servied above 60 customers in recent 3 years,including consulting/audit/training/csv/software infornmation management/annual service and so on,we will keep our current business,plan to expand GMP auditor training system, supplier audit and other business.

On your road to success, FMK will be your bright lighthouse, leading you through thorns and thistles, and dispersing the fog for you.