CarlsbadTech’s FDA Drug Regulatory Advisers – I

All over the world, drug regulators are now imposing more stringent measures for therapeutic products.  A massive medical device recall in August 2014 by the US Food and Drug Administration (FDA) is the largest single-day event on record, according to data provided by FDA. The rapidly growing pharmaceutical market requires regulatory clearance for all new and old drugs and devices.

We have worked with small and mid-sized firms as well as large multinationals to obtain FDA clearance and approval for a large range of products. Our team of FDA Drug Regulatory Advisers offer quick and efficient FDA clearance and remediation. We have decades of proven experience in the drug and medical device domain to assist you with federal regulatory review and approval processes for your products. Our medical experts can provide help with product development, global registration strategies and registration of products with the FDA.

Some of our key areas of expertise include:

• Preparation of FDA Regulatory Submission including 510k, PMA, NDA, ANDA, IND etc.
• Product development and investigation
• Preclinical studies
• FDA regulatory clearance
• FDA approval
• Assist with due diligence activities
• Business planning
• Post-approval compliance
• Post-marketing management
• Content creation and document services
• Warning Letters responses
• Quality Assurance and Quality Control
• Electronic Documentation

Our team will help you prepare responses to regulatory authorities, correspondence and assessment reports. We also work with you on Risk Management plans and electronic conversion of documents. In other words, our professionals will work with your team from the start to the post-marketing stage of your product. Our FDA Drug Regulatory Advisers will ensure that the commercial viability of your product is optimized for maximum mileage and exposure.

We have a large number of clients from all over the world and have worked successfully on the most complex regulatory issues. Our FDA Drug Regulatory Advisers are exclusively trained for the healthcare domain, making us a pioneer in this field. Our qualified advisers can compile the most effective regulatory dossiers for your new device or drug. With a thorough understanding of drug-related laws, we have the most suitable pool of advisers and experts to help you with your regulatory requirements. Our team of advisers and consultants understands the importance of marketing your product in the most affordable and efficient manner with the required FDA regulatory clearance. Contact us today for a free quote.