Strategic Regulatory Pathway to Success
Obtain 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 team has successfully guided novel drug and biologic companies through the complicated and complex FDA approval process. Our approach is designed to overcome regulatory hurdles and minimize product development time, risk, and cost.
Each year we prepare a wide variety of agency submissions for novel small and large molecules, biosimilars, and generic drugs. Our team has achieved a 100% success rate with on-time Investigational New Drug (IND) application submissions.
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.
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 assistance 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 preclinical and clinical regulatory environments to facilitate successful and timely agency interactions.
Regulatory Consulting and Management
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 filing strategies for new products, including post-approval management
- Regulatory gap assessments
- Indication and clinical trial strategic review
- Target Product Profiles
- FDA NDA, ANDA, and BLA assessment and plans
- FDA Special Designations: Orphan Drug, Rare Pediatric Disease, Qualified Infectious Disease Product, Animal Rule
- FDA Expedited Program Strategies: Fast-track, Breakthrough, Accelerated Approval, Priority Review, Real-Time Oncology Review
- Priority Review Vouchers (PRV): Rare Pediatric Disease, Tropical Disease, Material Threat Countermeasures
- Expanded Access IND (Compassionate Use)
- Feasibility risk assessment
Regulatory Planning and Gap Assessment
Often it is the strategy that fails, not the drug. Defining your goals and creating a strategic roadmap to help you mitigate time and cost risks is critical to success.
CSSi LifeSciences has the strategic insight and experience to provide innovative solutions that accelerate drugs from discovery to commercialization. We offer clients a head start through our deep understanding of the regulatory expectations and the guidance required to achieve success at each milestone during the development of a novel drug. This includes a thorough assessment of your existing data, prior regulatory filings, and the latest FDA guidances.
We provide customized regulatory solutions and a dedicated team 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.
Our experience includes:
- FDA meetings (i.e., Pre-IND; EOP; Type B, C, and D; Pre-NDA/BLA and BPE, Day 100 meeting)
- FDA INTERACT meetings (CBER and CDER)
- Health authority responses to questions
- Representation with FDA and National Competent Authorities
- Scientific Advice (EMA) meeting preparation and argument development
FDA Meeting Types
There are five types of meetings that occur between drug sponsors or applicants and FDA staff: INTERACT, Type A, Type B, Type C, and Type D. Each meeting type is subject to different procedures, as described below.
INTERACT
The INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER producTs) Meeting is a meeting intended to facilitate IND-enabling efforts when the sponsor is facing a novel, challenging issue that might otherwise delay progress of the product towards entry into the clinic. The INTERACT meeting:
- Provides an opportunity for preliminary informal feedback on CMC, preclinical, and clinical issues for innovative investigational products
- Occurs early in development, prior to the stage when a pre-IND meeting might be requested
Type A Meeting
Type A meeting is a meeting needed to help an otherwise stalled product development program proceed. Examples of a Type A meeting include:
- Dispute resolution meetings
- Discussion of clinical holds
- Special protocol assessment meetings
Type A meetings are scheduled to occur within 30 days of FDA receipt of the written meeting request.
Type B Meeting
Type B meetings include:
- Pre-investigational new drug application (pre-IND) meetings
- Certain end-of-phase 1 meetings
- End-of-phase 2 (EOP2) and pre-phase 3 meetings
- Pre-new drug application/biologics (pre-NDA/BLA) license application meetings
Type B meetings are scheduled to occur within 60 days of FDA receipt of the written meeting request. Generally, the FDA will not grant more than one of each of the Type B meetings for each potential application.
Type C Meeting
A Type C meeting is any meeting other than a Type A or Type B meeting between FDA CBER or CDER and a sponsor or applicant regarding the development and review of a product.
Type C meetings are scheduled to occur within 75 days of FDA receipt of the written meeting request.
Type D Meeting
A Type D meeting is focused on a narrow set of issues (limited to no more than 2 focused topics) and should not require input from more than 3 disciplines or Divisions.
Type D meetings are scheduled to occur within 50 days of FDA receipt of the written meeting request.
CSSi LifeSciences has extensive experience in meeting-document preparation and can provide you with best practices for a successful FDA meeting.
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.
We 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 throughout the submission process, including:
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Investigational New Drug applications (e.g., IND, CTA)
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Drug and Biologic Marketing Authorization applications (e.g., NDA, ANDA, BLA, MAA)
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Drug Master Files
- Global expansion: filing support documents for ROW submissions
Supporting Services
Integrated Project Management
CSSi LifeSciences provides all the relevant consulting and embedded management capabilities required to support drug discovery from concept through commercialization. We offer partial or fully integrated solutions to meet your needs by blending deep subject matter expertise with many years of scientific and project management experience. Our approach is based on understanding your unique needs and challenges, then crafting an integrated development plan to meet them.
On-Demand Development Team- A Proven, Flexible Model
Successful integrated drug discovery and development requires a cooperative team of multiple experts from diverse fields. Assembling an expert team for product development can be prohibitively expensive for small companies forced to bring in individual consultants as the needs arise. This approach typically leads to disjointed tasks not aligned with the product strategy, or a development strategy that does not consider the numerous aspects unique to each stage of development. Therefore, many virtual and emerging growth companies are looking for the help and experience only an accomplished consulting group can provide.
CSSi LifeSciences has a dedicated team ready to help you accelerate your product to commercialization. Our consultative, problem-solving approach is based on first understanding your unique challenges and then crafting a milestone-based and flexible plan to achieve your goals. We utilize a stepwise approach that is appropriate to each phase of product development.
Project Management
- Project planning and development
- Vendor sourcing and management
- Out-sourced staffing
CMC & Formulation Strategy
CSSi LifeSciences uses its expertise in project management and strategy to help clients successfully manage the drug discovery and development process, including Chemistry, Manufacturing, and Controls (CMC) and formulation strategy. Our team has a deep understanding of the challenges and opportunities involved in GMP commercial drug development. Our CMC development team can provide you with fully integrated solutions from process development and scale-up to GMP release testing.
- CMC consulting: We provide expert guidance on all aspects of CMC development for GMP. Our experts can assist with the regulatory aspects of analytical development, manufacturing process development and identification of critical quality attributes.
- Formulation development: We help clients understand the need for formulation strategy, including the optimal timing within the drug development program. We have formulation experts who can assist you and work with your chosen CRO to optimize the drug product formulation to ensure stability and effectiveness, and that the drug is suitable for the intended route of administration.
- Audits: We routinely conduct vendor quality audits and develop risk-based quality improvement plans and help clients prepare for FDA pre-inspection audits and best practices under the current FDA guidances.
- Regulatory affairs support: We have expertise to help clients navigate the complex regulatory landscape, including preparing and submitting regulatory applications and managing regulatory inspections.
Contact us today to learn more about how we can support your CMC program.
Nonclinical Safety Assessments
CSSi LifeSciences uses its expertise in project management and strategy to help clients successfully design and manage an IND-enabling program that will best support the lead indication and overall commercial development plan. Our preclinical development team can provide you with fully integrated solutions to accelerate you to First-in-Human (FIH) clinical trials, as well as support you from both a regulatory and program management perspective for any nonclinical studies required for the marketing application.
- Nonclinical Safety Consulting: Our team has extensive experience in designing in vitro and in vivo safety evaluation programs in accordance with the latest FDA guidances.
- Protocol development: We help clients develop nonclinical pharmacokinetics, safety pharmacology, and toxicology studies, including identifying the appropriate study design, species selection, and endpoint measures.
- Study management: We provide management for the conduct of pharmacology, ADME, PK and safety studies, including CRO selection and management and quality audits (both facility and in-study).
- Regulatory affairs support: We have the expertise to help you navigate the complex regulatory landscape, including preparing and submitting regulatory INDs.