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CSSi LifeSciences offers regulatory affairs services to help minimize product development time and accelerate product approval. Our expert team provides guidance and solutions to regulatory hurdles. We prepare numerous agency submissions each year and are experienced in handling a wide range of therapeutic areas and project types, from small to large molecules, biosimilars, and generic drugs.

Developing strategies, representing sponsors, and writing and submitting filings to regulatory authorities is our bread and butter.

Our Unique Approach

With CSSi LifeSciences It’s As Easy As One, Two, Three.

Regulatory Services

We provide customized regulatory affairs services for global markets and support the full product lifecycle for products
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Regulatory Consulting and Management

  • Regulatory consulting
  • Define regulatory requirements and recommendations for new products, regulatory filing strategies and post-approval changes
  • Gap assessments
  • FDA 505(b)(2) assessment and plans
  • FDA Special Designations (i.e., Orphan, Fast-track, Breakthrough, Gain Act Designations)
  • Target Product Profiles
  • Emergency Use Authorization and Expanded Access IND
  • Label development and negotiation
  • Oral explanations
  • Feasibility risk assessment
  • FDA and QMS Audits
  • Advertising and promotional material review
  • Clinical operations
  • Biologic exclusivity

Health Authority Interactions and Meetings

  • In-country representation and registration
  • FDA Establishment Registration
  • FDA meetings (i.e., Pre-IND, Type B and C, Pre-NDA / BLA and BPE, Day 100 meeting)
  • Health authority responses to questions
  • Representation with FDA and National Competent Authorities
  • Scientific Advice (EMA) and argument development

Drug Submission Services