A regulatory strategic plan is critical to defining the overall product development planand the fastest path to marketing. It considers regulatory agency expectations andprecedence for the technical, nonclinical, and clinical data necessary to supportregulatory action. The strategic plan provides timelines and milestones for necessaryactivities and the implications of delays.

Whether this is the first or tenth product you have brought to market, carefulpreparation for each milestone and the possible challenge is necessary or your entiredevelopment strategy could be derailed. Planning is key to this process, and knowledgeof each regulatory agency’s intricacies is a major plus.

Whether you need help executing your entire chemistry, manufacturing, and controls(CMC) strategy, producing an FDA briefing package, or conducting a “DevelopmentMilestone” Meeting, DSI’s experience and positive working relationship with the FDAmeans we will get the job done right. We work with you to do what is necessary tomove to the next milestone.

Our Project-Based Regulatory Strategyand Submission Services Include:

• Pre-IND Meeting – To the best extentpossible, any meeting with the Agency shouldend in clarity. During the Pre-IND Meeting,Sponsors have the chance to discuss the CMCrequirements for opening an IND with theAgency.

• End of Phase 2 Meeting – During thismeeting, you need to effectively present yourPhase 3 and development strategy and ensurethat you are aligned with the FDA prior to thestart of Phase 3.

• Pre-NDA Meeting – When you leave yourPre-NDA Meeting, you should have anunderstanding of the FDA’s expectation forcontent. During the Pre-NDA Meeting, youmust make the most of the opportunity tosolicit comments and clarification from theAgency on the acceptability of data required.

• NDA Submission: 505(b)(1) and 505(b)(2)Assistance – As you can imagine, this type ofsubmission requires extensive research,including both clinical and nonclinical studiesto prove the product’s safety and efficacy forthe indication being sought.

Strategic CMC AssessmentWhen beginning with a concept drug candidate, the first important step in an efficientdrug development path is to determine its feasibility. For New Chemical Entity (NCE)drug pathway candidates, a strategic assessment is especially important. This is whereDSI can help by utilizing its strategic assessment services.

Done right, a strategic assessment determines the key components of the drugdevelopment plan, like a roadmap for a trip. Without a roadmap, it is possible to reachthe desired destination. But with an informed roadmap, it is possible to reach thedesired destination by planning for efficiency from the beginning, spending the leastamount of time and money to get there.

Here at DSI, we believe a strategic assessment is the first key to a drug candidate’ssuccess, making go/no-go informed decisions at the beginning, and evaluating andplanning for the scientific, technical, regulatory, and commercial aspects of a product’sdevelopment.

REGULATORYSTRATEGYDEVELOPMENT

Evaluate and provide guidance on all aspects of regulatory CMCstrategy for product developmentSupport clients developing biologics, small molecules, devices,biosimilars, and combination productsAdvice on CMC compliance with Orphan Drugs Designation, Fast Track,Break-through Therapy, Accelerated Approval, ANDA, and 505(b)(2)submissionsConduct due diligence assessments

Regulatory Strategy & Due Diligence:

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Project-Based Regulatory Strategy & Submission Services

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CommercialViability

Is there a viable supply chain for theproduct? What is the potential forfuture competition or substitution?

RegulatoryViability

What data will be required to gain

approval? Can development beexpedited? Would exceptions or

commitments (“be negotiated”) beavailable? What distinguishing

information can be presented withinthe negotiation for eventual binding

agreement?

Scientific Viability

Does the science make sense? Forinstance, is the formulation stable

and readily prepared? Ismanufacturing scalable? Are activeand inactive ingredients available

and affordable?

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