PharmSupport helps pharmaceutical and biotechnology companies with the design and creation of drug and biologic product development strategies and regulatory documents to get products to market. PharmSupport helps with:
Regulatory and development strategy, including the creation and review of product development plans, clinical study protocols, briefing documents for regulatory meetings, and submissions, mapping an efficient and cost-effective path for a product’s development
Regulatory document preparation, including investigational new drug applications (IND), clinical study protocols, clinical study reports (CSR), investigator brochures, manuscripts for publication in scientific journals, new drug (NDA) and biologics license (BLA) applications, and many other regulatory documents needed for product development and marketing
Regulatory submission services including expert submissions preparation and management, medical writing, and document publishing in eCTD format
Regulatory document review to provide a fresh perspective on plans and documents
Meeting facilitation and project leadership and management, to help drive teams toward defined action plans and consensus
Creation of custom teams to assemble the experts needed for specific projects, such as nonclinical, pharmacokinetics, quality, and other expertise as dictated by a project
We do a lot more, too! Please contact us to discuss the specifics of your project!