Expert Advisory Services
ProPharma Group provides high-value advisory services through its worldwide base of top-tier expert consultants, who support the full product development life cycle, from initial concept to marketing authorization. Advisory services include product development and regulatory strategy, development program planning and management, and expert scientific and technical advice. ProPharma Group’s worldwide team is comprised of highly knowledgeable experts with extensive experience preparing and submitting applications, including:
- Investigational New Drug (IND) applications
- Abbreviated New Drug Applications (ANDAs)
- New Drug Applications (NDAs)
- Biologics License Applications (BLAs)
- Premarket Approval (PMAs)
- 510(k) (Premarket Notification) and de novo submissions
- Special designations
ProPharma Group’s team of experts can act as the Regulatory Representative for the FDA and international regulatory bodies on behalf of a client and can take on leadership roles such as membership on Scientific Advisory Boards or working on a part-time basis as an interim executive (e.g., Chief Medical Officer, Head of CMC, and Head of Regulatory Affairs).
In addition to regulatory submissions, we can also help you prepare for and conduct meetings with the regulatory agencies. Our team of regulatory and product development experts have conducted hundreds of successful meetings with FDA, EMA, and NCAs throughout Europe and have done so as the consultant, Sponsor, and the regulator. As such, we have ability to consider the perspective and thought process of the individuals on both sides of the table, enabling us to have higher success rates when interacting with the Agency than anyone else.
Contract Development Teams
ProPharma Group has developed a unique and powerful capability for partnering with inventors, discoverers, and owners of intellectual property and early-stage biopharmaceutical and medical device companies as a contract development organization (CDO). For these clients, ProPharma Group’s experts form world-class product development teams (PDTs) that design, plan, and manage the product development program(s) for our clients.
Benefits of a ProPharma Group PDT include:
- Project teams consisting of highly respected top-tier expert consultants with proven track records in product development
- Enhanced credibility with prospective investors
- Avoidance of equity dilution associated with awarding stock options to in-house staff
- Rapid program initiation
- Immediate adaptation of team composition as the required functional expertise changes over the course of the development program, and immediate access to supporting expert consultants in specialized areas, as needed
Expert Witness Services
ProPharma Group provides litigation support services for the major law firms serving the pharmaceutical industry in cases involving claims such as antitrust violations, patent infringement, product liability, and supply chain failures. Services are provided by our team of top-tier experts, including former FDA and industry senior executives, and may encompass expert reports, depositions, and trial testimony.
Call or fill out a form today to discuss your needs and learn more about how ProPharma Group can help you design and execute a world-class product development program.