Medical affairs is about relationships – between you and customers, your customers and your products, and between your business objectives and our services.
DDN Medical Affairs expertly handles the crucial relationships that support and sustain your products and your business.
We provide your customers, from consumer to healthcare provider, with prompt, accurate product information in a friendly, professional manner so that they remain satisfied with, confident in, and loyal to your products. We help you anticipate and meet complex and ever-changing regulatory requirements. And our service system is designed to support your business goals, integrate seamlessly with your internal departments, and be fully transparent to your customers.
When customers contact you by phone or fax, they’re seamlessly patched through to our call center, where experienced healthcare and regulatory professionals quickly, accurately answer their questions.
We know that every contact is a reflection on your brand, and we take the responsibility seriously. Our regulatory staff has prepared and submitted NDAs and ANDAs, and has provided post-approval regulatory support for branded and generic products. Compliance with all applicable FDA regulations and guidances is at the foundation of our services.
Our goal is to assure your healthcare providers and patients that you are committed to safe and appropriate use of your products.
Our primary services include:
- Adverse Event Reporting
- Adverse event reports are accurately documented, assessed, coded, and evaluated by our medical professional staff. Individual case reports and periodic adverse drug experience reports are prepared and submitted to you and the FDA, and we retain all records in accordance with regulatory requirements.
- Product Complaint Reports
- We provide a team well versed in complaint evaluation that fields and documents incidents, facilitates returns and refunds according to your specifications, can coordinate with your quality assurance team, and retains the records in accordance with regulatory requirements.
- Medical & Technical Product Inquiries
- From the straightforward question about inactive ingredients to complex drug interaction information, we strive to provide accurate, balanced, timely information to your customers with personal attention and thoroughness they will remember. Inquiries are handled by medical professionals and regulatory staff trained specifically on your products and skilled at tailoring responses to the individual.
- Labeling Management
- Labeling and package inserts are critical components of product success, and we develop and process yours in accordance with FDA regulations — including conversion to the SPL document markup standard enacted in June 2009, as well as submission of SPL documents. We also monitor FDA Web sites for changes to innovator labeling and provide prompt alerts to you.
- Other Services
- Our consulting areas of expertise include compliance with advertising and promotional regulations, regulatory guidance for post-approval issues, product training, and medical writing.
