A message from President
Have you kept in mind "regulatory affairs leading to business success"?
As general awareness of health increases with the greying population, "medical care" is garnering attention as a growth industry. Leveraging proprietary technologies, companies with diverse backgrounds are entering the medical device market as a new business field.
Although "regulatory affairs" tend to be seen merely as compliance with regulations, pharmaceutical application documents are important since they determine the orientation of a medical device business. For business success, it is crucial to consider the target market, product features and marketability, while reflecting these in the application documents.
We support "regulatory affairs leading to business success," rather than just helping prepare documents. Our perspective ranges from identification of market needs to creation of an organizational structure which will enable a business to continue flourishing.
President
Regulatory Consultant
Michiko Masaka, Ph.D.