ADE Evaluation/Drug Safety Assessment, Adverse Event Management/Software, Chemistry/Manufacturing/Controls, Consulting, Medical Communications, Medical Devices/Combination Products, Medical Information, Pharmacovigilance, Regulatory Affairs/Regulatory Strategy, Telephone Support
DDN Medical Affairs provides an integrated, centralized system to manage drug safety, medical product information, product quality complaints and regulatory affairs services for pharmaceutical, biotech and medical device companies. These services support the commercial success of our clients by connecting their healthcare providers and consumers with accurate, timely information about the safe and appropriate use of their products and by protecting their company through compliance with FDA regulations. DDN Medical Affairs enables our clients to focus on their strategic business objectives while we focus on operational functions of the business.
Senior management includes professionals with a broad spectrum of medical information and communication, regulatory and marketing experience. We've carefully chosen every member of our staff to ensure that we have deep industry expertise in each area of service we provide.
· Our Medical Director has more than a decade of experience in post-marketing safety surveillance.
· Our call center is staffed with healthcare professionals with clinical experience in pharmacy and nursing as well as industry experience in medical and drug information.
· Our Regulatory Affairs staff has decades of collective industry experience, including submission of adverse event reports, post-approval changes, annual reports, labeling development and management, and promotional compliance.
Adverse Events – When we interact with healthcare providers and patients, we clearly communicate our clients' commitment to safe and appropriate product use. All adverse events are documented and processed by our healthcare and medical staff. Individual case reports and periodic reports are prepared and submitted for you.
Product Information – Our healthcare professionals provide accurate, balanced, timely information with personal attention and thoroughness that our clients' customers – healthcare providers, patients and consumers – expect. Standardized responses are typically provided on the initial contact. We develop customized responses to complex and uncommon questions.
Product Quality Complaints – Every complaint contact is an opportunity to preserve and build customer satisfaction and loyalty. We process complaints from receipt through closure including assistance with product return to manufacturer and compensation to the complainant based on our clients' business rules.
Structured Product Labeling Services (SPL) – Let our SPL specialists complete the conversion process for you. Our clients keep their staff focused on its key priorities. This solution ensures that content of labeling, establishment registration, drug listings and NDC labeler code requests meet the new requirements quickly and accurately.
DDN Medical Affairs
Connect – Attentive to customer needs
Protect – Attuned to regulatory requirements
Succeed – Aligned with clients' goals
Services: Professional call center, Adverse Events, Product Quality Complaints, Medical Product Information, Labeling, Consulting