Strategic Regulatory Pathway to Success
CSSi LifeSciences has extensive knowledge and over 500 combined years of experience in developing drugs and bringing them to market. Our team has successfully guided novel drug and biologics companies through the complicated and complex FDA approval process. Our approach is designed to overcome regulatory hurdles and minimize product development time, risks, and cost.
Our Unique Approach
With CSSi LifeSciences, It’s as Easy as One, Two, Three.
- We help you unlock value by engaging effectively with regulatory health authorities through regulatory plans that support and align with your product development milestones.
- We provide a customized regulatory solution and the support of a dedicated team throughout the life of the project based on your needs and stage of development.
- Our staff helps you navigate the complex and evolving regulatory environment to facilitate successful and timely agency interactions.
We are experts in successfully navigating the health authority and regulatory landscape for drugs and biologics, and have done so in over 100 countries. Our team has achieved a 100% success rate with on-time Investigational New Drug (IND) application submissions.
Each year we prepare a wide variety of agency submissions for small to large molecules, biosimilars, and generic drugs. Get both the expertise and the solutions you need from a dedicated, successful team who knows how to navigate the FDA’s regulatory and oversight processes.
Our goal is to develop strategies that align with our clients’ interests so that they may remain focused on what they do best: innovating and developing the next generation of successful therapeutics.
Regulatory Consulting and Management
Health Authority Interactions and Meetings
CSSi LifeSciences has extensive experience in the conduct and management of FDA and Health Authority Meetings and formal communications to provide the guidance and clarity necessary to execute your regulatory and clinical development program to ensure a basis of approval, including:
- FDA meetings (i.e., Pre-IND, EOP, Type B and C, Pre-NDA/BLA and BPE, Day 100 meeting)
- Biologic INTERACT
- Health authority responses to questions
- Representation with FDA and National Competent Authorities
- Scientific Advice (EMA) meeting preparation and argument development
We provide customized regulatory affairs services for global markets and support the full product lifecycle, including:
- Regulatory consulting and project management
- Defining regulatory requirements and recommendations for new products, regulatory filing strategies, and post-approval changes
- Gap assessments
- FDA 505(b)(1) and 505(b)(2) assessment and plans
- FDA Special Designations (i.e., Orphan, Fast-track)
- Priority Use Voucher (PUV)
- Target Product Profiles
- Expanded Access IND
- Label development and negotiation
- Feasibility risk assessment
- Advertising and promotional material review
- Clinical operations
- Biologic exclusivity
Drug Submission Services
Submissions & Communications
The CSSi LifeSciences Regulatory Team has demonstrated tremendous success in completing a wide variety of submissions to health authorities in the U.S. and abroad. Our record speaks for itself. Our staff understands the guidances and the FDA “speak” required to successfully guide a new submission to the U.S. market. We are experts in creating documentation that addresses FDA requirements and minimizes the need for clarifications and follow-up questions.
Our integrative process provides a 360-degree assessment to achieve positive results for the most challenging and complex submissions.
We both lead and collaborate with teams to strategize, develop, write, edit, review, and submit all required FDA technical documents and submissions. From the U.S. FDA CDER and CBER Pre-IND Meeting Request ,as well as a host of others, our team of regulatory experts will be your trusted partners through the submission process, including:
- Investigational New Drug applications (e.g., IND, JMPD, MFDS, CTA)
- Drug and Biologic Marketing Authorization applications (e.g., NDA, BLA, MAA)
- Drug Master Files
- 505(b)(1) or 505(b)(2) applications
- Generic drug applications (e.g., ANDA)
- Label and package leaflets, and user testing for readability
- Global expansion: filing support documents for ROW submissions