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 Your
Success in Obtaining Regulatory Approval
Regulatory success is more than permission
to market your product. Regulatory approvals specify product
labeling that limits your ability to advertise and promote
your product to physicians and other key constituencies. Your
regulatory strategy needs to be carefully aligned with your
reimbursement and marketing needs. Your documentation and
presentations must be accurate and persuasive to meet the
requirements of regulators.
BMS Goal for Regulatory Services
To provide strategies and solutions that
help our clients achieve regulatory approvals that enable
market success.
BMS Regulatory Services
BMS offers regulatory services that cover
the full range necessary for your product to achieve approval.
- FDA Relations
- Regulatory Submissions: IDE, PMA, 510(K), IND, NDA, etc.
- Technical and Medical/Statistical Reports
- Organizing and Preparing for Meetings with FDA
- Quality Systems and Compliance Counseling
- Medical Device and Manufacturing Design Controls
- Device Classification/Predicate Device Searches
- International Registrations
- Answering Deficiency Questions
The BMS Difference in Regulatory Services
- BMS has the scientific expertise and depth to make our
clients' documents and presentations to the FDA professional
and persuasive
- BMS helps our clients obtain labeling that will facilitate
market acceptance
- BMS keeps current on policy and regulatory changes
- BMS can structure a regulatory program that is appropriate
to products in early or late stages of product development
or are already on the market
- BMS participation in the ASTM, an international consensus
standards organization, enables us to actively influence
the reception of new technology by regulatory authorities.
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2008