CMC for 505(b)(2) Applications

Comprehensive Clinical Development Services Camargo's knowledgeable pharmacokineticists work diligently to determine the proper PK study designs needed to support a successful clinical drug development plan while avoiding unnecessary and costly studies. Expertise includes Phase I PK data analyses — both compartmental and non-compartmental — and interspecies scaling for first-time studies in humans. In addition, our PK staff has highly specialized competency in the bioequivalence study process.PK expertise includes, but is not limited to: Design of pharmacokinetic studies in humans and animals Pharmacokinetic data analyses (compartmental and non-compartmental analyses) Interspecies scaling Bioequivalence study design and data analyses Clinical endpoint study design and data analyses Preparation and submission of the human clinical trials section of the NDA regulatory application Phase I, II and III StudiesQuality performance, timeline management and cost control are our watchwords at Camargo as we navigate you through Phase I, II and III. In Phase I development, while a 505(b)(1) may take up to 6.5 years to reach an INDA submission, the 505(b)(2) pathway requires a fraction of that time and often allows preclinical and clinical analyses to be completed in parallel, abridging the process even further. Pre-Study and Course-of-Study Activities: Study design and protocol writing IND preparation and submission Bioanalytical lab selection Bioanalytical method selection and validation review Management of institutional review board (IRB) submissions Case report form (CRF) development CRO selection Tracking and communication of milestones Post-Study Activities: ICH reports FDA presentations, interactions and communications Presentations at scientific meetings Manuscript writing Preparation of annual reports Phase IV StudiesCamargo approaches Phase IV studies with the same knowledge, diligence and efficiency as we do for clinical studies in Phases I through III. Our clinical and regulatory experts expedite the Phase IV clinical process from beginning to end via a streamlined, highly practical process that uses established methodologies and well-focused studies.

Camargo ensures the appropriate regulatory requirements are met every step of the way, streamlining your drug development process all the way to approval.Ready to guide you through the preclinical stage of drug development, Camargo provides strategic support in the following areas: CRO selection Study design Study setup and execution Project management In clinical program development, camargo's focus is unwavering: Move products from preclinical through to FDA approval as efficiently as possible. Using proven methodologies that can meet FDA guidance requirements and expedite the drug approval process while reducing overall study costs.Experts develop a customized clinical program plan for each drug, which includes only the services necessary for preparation and hands-on implementation.Also seasoned medical writers apply their proven research and investigation skills to design protocols that streamline the clinical trial process, reduce study costs and expedite the drug approval process. When protocol design is complete, Camargo's team moves from planning to implementation, all the while working in close partnership with your team.Camargo Clinical Design Expertise: Bioavailability Bioequivalence Comparison Dose-ranging Drug interaction Drug metabolism Efficacy Patient preference Proof-of-concept Quality of life Radiopharmacology Safety

Ready 4 Action, proprietary feasibility assessment, sets the cornerstone of a cost-effective product development plan. Ready 4 Action is the four-step process used to evaluate the viability of proposed drug products. This important tool enables clients to make the go/no-go decision regarding a given drug's market potential and clinical development feasibility.Armed with the neccessary intelligence, uncover with Ready 4 Action — including details of key factors influencing the pharmaceutical marketplace, the regulatory status and the clinical strategy involved in development of a specific drug — clients can make well-informed drug development decisions and avoid unnecessary and potentially destructive financial risks.Camargo's Ready 4 Action assessment includes detailed data pertaining to your specific drug, along with a proposed clinical development plan — an invaluable feature of the assessment — and a schematic of the proposed plan. Incorporating major decision points and cost estimates, your plan includes clinical pharmacology, preclinical studies, pharmacokinetics and regulatory recommendations — that’s why it is a critical first step in the race to drug approval.Ready 4 Action Product Planning Service Assessment: Scientific Viability - Does the science make sense? For instance, is the formulation or chemistry practically and pragmatically achievable? Is it scalable? Are API ingredients available and affordable? Medical Viability - Does the product have a clear niche in the medical specialty? Is it effective for solving a unique problem or solving a problem in a unique way? Does it present an acceptable risk/benefit? Is it appealing to the proposed patient population? Regulatory Viability - What clinical trials or other data will be required to gain approval? Can development be expedited? What distinguishing information can be presented on the labeling for eventual promotional activity? Commercial Viability - Is there a viable market for the product? What is the potential for future competition or substitution? What is needed to ensure reimbursement? What is the optimal pricing?