PharmSupport helps companies overcome the regulatory hurdles to advance your product development and get your products to market. Here are just some of our services that could benefit your pharmaceutical, biologics, or medical device company:
Regulatory strategy and services, including the creation of product development plans, briefing documents for regulatory meetings, and submissions, mapping an efficient and cost-effective path for your product’s development
Medical consulting in the areas of drug development, clinical study design, review of medical, clinical, and regulatory documents, adverse event and medication coding, and subject narratives, ensuring the medical accuracy and relevance of your documents and plans
Regulatory document preparation, including investigational new drug applications (IND), investigational device exemptions (IDE), clinical study protocols, clinical study reports (CSR), investigator brochures, manuscripts for publication in scientific journals, 510(k) notifications, premarket approval applications (PMA), and new drug (NDA) and biologics license (BLA) applications: delivering high-quality documents that communicate your messages accurately, completely, and effectively
Complete regulatory submission services including regulatory liaison services, expert submissions preparation and management, and document publishing in either paper or eCTD format, performing these activities cost-effectively while allowing you to spend your time and energy on other things
Creation of custom teams: providing the experts you need for a specific project including nonclinical, chemistry, manufacturing and controls, pharmacokinetics, quality, and additional expertise as dictated by your project
Project leadership and management: devising, discussing, and implementing plans, and coordinating teams to advance your company’s goals
Whether your existing staff is overloaded or you simply want to focus on your core competencies without acquiring expertise in every area of product development, let PharmSupport help.
Don't see what you need? Please contact us to discuss if we can help!