SMB Validation

What industries does SMB serve?

SMB Group serves three major markets: The Pharmaceutical, Medical Device and Biotechnology manufacturers or PMDB industry and the Equipment Designers and Builders that are suppliers to the PMDB industry. Additionally training opportunities exist for those individuals who wish to enter or stay current within the PMDB industry.

1. The primary target market encompasses all PMDB Manufacturers and their immediate subsidiaries that are subjected to FDA and other similar regulations as well as some of their major direct suppliers. Laws & Regulations in this targeted market are becoming more and more stringent and will result in the compliance functional units of PMDB manufacturers having to meet ever-increasing requirements.

The services of SMB Group are based on USFDA regulations. Many PMDB Manufacturers wish to apply a consistent standard to all their installations regardless of their actual geographical locations. The FDA regulations being generally recognised as the most exacting in the world, they are frequently selected as the reference standard. Moreover, with continued development of new biotechnologies, the target market is continuously expanding. New Biotech companies are continually created. Most Biotech companies are purposely maintained as relatively small business entities in order to minimise the risk in the event of a catastrophic adverse event that could literally “sink” the company. Because of their relatively small scale, many of these, if not most, are not staffed with all the traditional disciplines.

2. The second target market for SMB Group consists of the numerous Equipment Designers/Manufacturers and Distributors that are suppliers to the PMDB industry. With the shrinking of internal support staff within the PMDB industry alluded to above, the industry is turning to the Equipment Designers and Builders to provide more extensive documentation than has traditionally been the case. Requests for quotation from PMDB customers now typically include requirements to provide Detailed Design Specifications as well as other similar support documentation. Most Equipment Manufacturers are ill prepared to deal with such requirements and risk not being seriously considered by the PMDB manufacturers when they seek production and packaging machinery.

3. The third strategic market targeted by SMB Group will consist of providing training programs for individuals who wish to enter the PMDB manufacturers market or who wish to further develop their knowledge of the PMDB industry and, as mentioned above, for the personnel employed by equipment manufacturers and distributors.

Another field of opportunity lies with cGMP training for the engineers, designers and sales representatives of equipment manufacturers. Adequate cGMP training will enable the engineers and designers to better understand the requirements of their customers and thus provide equipment better suited to these needs. Similarly, the equipment distributors’ sales representatives can benefit from this type of training and hold more productive discussions with their customers by being able to “speak the same language”.