SERVICES

REGULATORY AFFAIRS SERVICES

The partners of Scientific Commercialization have extensive regulatory expertise, regulatory team leadership experience, and hands-on experience performing regulatory affairs services in the development of drugs and biologics.

Our approach is to have regulatory knowledge thoroughly integrated with preclinical and clinical drug development, and commercialization expertise, in order to create an effective strategic focus for a product's commercial success.

FDA Liaison and Support

Scientific Commercialization can serve in a number of regulatory liaison capacities:

• The partners have extensive experience interacting with FDA Centers and review divisions, as well as regulatory authorities outside of the U.S.
• Scientific Commercialization can act as a direct liaison with the FDA for planning of regulatory submissions, responding to critical questions from the agency, and for discussions on key issues in the development of a product.
• The partners can also serve as an official authorized regulatory agent for foreign firms that do not have a U.S. office or affiliate. In this capacity, Scientific Commercialization will be the customer's direct contact and voice with the FDA.
• Scientific Commercialization provides services to support critical meetings with the FDA, including the preparation and review of key meeting "briefing documents", meeting attendance, and preparation and review of meeting minutes.

Regulatory Strategy and Product Development

In today's competitive pharmaceutical and biotech market, the success of any new product depends on how well a company integrates a well-conceived strategic product development plan with the essential components of a sound regulatory strategy.

Scientific Commercialization can provide key services to this end, which include:

• Conduct of a regulatory review of available product data, including information on the regulatory history including any prior regulatory submissions, and correspondence with FDA, as well as key information on the pharmacology, toxicology, and pharmacokinetics in animals and (if available) humans, and any data relating to the safety and effectiveness in humans from prior clinical studies.
• Prepare concise, focused regulatory opinions on the therapeutic potential of the product, and an assessment of the potential therapeutic indications.
• Research the FDA's (and other regulatory agencies) present opinions and current guidance on development programs, clinical endpoints, and clinical trial designs in the potential indication(s).
• Recommendations on regulatory strategy, including the applicability of any accelerated development or approval pathways under current regulations.
• Evaluate specific regulatory requirements for achieving approval based on: prior product precedents; review of relevant Advisory Committee opinions; current FDA policy and unique requirements in appropriate review divisions.

Regulatory Submissions Preparation and Filing

The partners of Scientific Commercialization have experience in team leadership and in the hands-on preparation of critical regulatory submissions, including original INDs and annual reports, original NDA/BLAs and post-marketing reports, as well as product labeling.

Scientific Commercialization can provide key authoring of major sections of a submission, conduct an extensive senior review of the complete submission, and assist with the final preparation and submission of complete documents.

Marketing and Advertising

Scientific Commercialization can provide comprehensive regulatory reviews of marketing activities, and promotional claims for products.

Scientific Commercialization also provides intensive in-house training for sales and marketing staff focusing on awareness and compliance issues with current FDA policies and guidance in marketing and promotional activities for approved and investigational products, including FDA's current position on off-label promotion regulations and FDA's review and enforcement actions in CME, and scientific or educational activities.

Regulatory Training Programs

Scientific Commercialization can provide comprehensive in-house training programs covering a diverse range of topics relevant to regulatory affairs, including:

• Basic regulatory practice
• Strategic regulatory approaches to product development
• IND planning and development
• Good promotional practices
• Regulatory compliance in late phase and post-marketing programs

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