DRUGS, BIOLOGICS, & COMBINATION PRODUCTS
- Regulatory Strategy Development & Gap Analysis
- Regulatory Meeting Preparation & Submissions
- Nonclinical Development
- Clinical Development
- Human Factors for Medical Devices
- Due Diligence & M&A
- Veterinary Products
Regulatory Strategy Development and Gap Analysis
toXcel’s expert team helps you navigate complex global regulatory requirements, accelerating your path to market.
Our Services Include:
- Regulatory Strategy Development: Tailored strategic planning for biologics, pharmaceutical drugs, and combination products, ensuring alignment with FDA and international regulatory bodies.
- Regulatory Gap Analysis: In-depth evaluation of your current product development plans, identifying compliance risks and opportunities to strengthen regulatory submissions.
- Strategic guidance on regulatory pathways including traditional and non-traditional pathways: The regulatory pathway is a fundamental aspect of product development and can have a significant impact on the timeline, costs, and success of a new product.
- Orphan Drug Designation
- Fast Track
- Breakthrough Therapy Designation
- Accelerated Approval
- 505(b)(2) New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Submissions
- Animal Rule applications
Regulatory Meeting Preparation and Submissions
Successful regulatory interactions are critical to the progress of your product development. toXcel provides expert support for preparing and submitting key regulatory documents, as well as strategic guidance for engaging with health authorities like the FDA.
Our Services Include:
- Regulatory Submission Support: Author, review, and publish original submissions and updates, including:
- Investigational New Drug (IND) applications
- New Drug Applications (NDA)
- Biologics License Applications (BLA)
- Amendments and supplements
- Agency Meeting Preparation: Assist in preparing for key regulatory meetings (Type A-D and INTERACT). This includes developing and reviewing briefing packages, and aligning messaging with program goals.
- Meeting Logistics & Submissions: Manage meeting requests, timelines, and electronic submissions through the FDA’s Electronic Submissions Gateway (ESG) or other platforms.
- Strategic Regulatory Advice: Provide insight on regulatory options and pathways, including fast-track programs, special designations, and optimal meeting strategies to align with development milestones.
- Agency Representation: Represent clients in direct communications and formal meetings with the FDA and other regulatory authorities, ensuring clarity, accuracy, and consistency in messaging.
Nonclinical Development
Robust nonclinical development is essential to ensure the safety, efficacy, and regulatory compliance of pharmaceuticals, biologics, and combination products before advancing to clinical trials.
Our Nonclinical Development Expertise Includes:
- Strategic Planning & Program Design: Review, advise, and develop customized nonclinical development strategies, study programs, and detailed plans that align with regulatory requirements and product objectives.
- Pharmacology, Safety, & Toxicology Study Design: Design scientifically sound and regulatory-compliant study protocols for pharmacology, safety pharmacology, and toxicology studies.
- GLP Compliance & Consulting: Provide guidance on Good Laboratory Practice (GLP) standards, offer oversight to ensure compliance, and support GLP audits for nonclinical studies.
- Protocol & Report Review: Evaluate nonclinical study protocols and reports for scientific rigor and regulatory compliance to ensure data integrity and alignment with global regulatory expectations.
- Nonclinical CRO Selection & Monitoring: Support the selection of qualified Contract Research Organizations (CROs), oversee study conduct, and monitor progress to maintain study quality and regulatory adherence.
Clinical Development
Effective clinical development regulatory support is critical to navigating complex regulatory pathways and ensuring successful progression of your product through clinical trials to market approval. ToXcel collaborates with leading clinical development firms to provide expert regulatory guidance across all phases of clinical trials.
Our Clinical Development Support Includes:
- Regulatory Expertise Across All Clinical Phases: Provide specialized clinical regulatory support for products at every stage of clinical development, from early Phase 1 trials through Phase 4 post-marketing studies.
- IND, NDA & BLA Strategy Development: Develop regulatory strategies and offer guidance for Investigational New Drug (IND) applications, New Drug Applications (NDA), and Biologics License Applications (BLA) to align clinical development with agency expectations.
- FDA Meeting Preparation: Assist in preparing FDA meeting requests, briefing packages, and supporting documentation to facilitate productive interactions with regulatory agencies.
- Gap Analysis & Due Diligence: Conduct clinical development gap analyses, prepare comprehensive product development plans, and perform due diligence assessments to identify and mitigate regulatory risks.
- Clinical Protocol Development: Design Phase 1 through Phase 4 clinical trial protocols that are scientifically sound and compliant with regulatory standards.
- CRO Selection & Clinical Trial Monitoring: Support the selection of qualified Contract Research Organizations (CROs) and provide oversight and monitoring throughout the clinical trial process.
Partner with toXcel to leverage expert clinical regulatory support that enhances your clinical development programs through effective collaboration and strategic insight.
Human Factors for Medical Devices
Human Factors Engineering is essential to developing safe, effective, and user-friendly medical devices and combination products that meet FDA and international regulatory expectations. At toXcel, we provide expert Human Factors (HF) support throughout the medical device development lifecycle. Our services are designed to improve device usability, reduce use-related risk, and ensure compliance with regulatory standards.
Our Human Factors Services Include:
- Usability Engineering & Validation Study Design: Design Human Factors validation studies and usability engineering processes tailored for medical devices and combination products to meet regulatory requirements and user needs.
- Lifecycle Support: Provide comprehensive support across the product lifecycle, including task analysis, user risk assessments, formative usability testing, heuristic reviews, and summative validation studies.
- Regulatory Compliance & Risk Reduction: Assist in designing safer, more intuitive devices that align with FDA Human Factors guidance and international standards such as IEC 62366, helping you reduce use errors and meet regulatory expectations.
Work with toXcel to ensure your medical devices are designed with the user in mind—enhancing safety, usability, and regulatory readiness from development through approval.
Due Diligence and M&A
Thorough due diligence is critical to informed decision-making and successful outcomes in pharmaceutical and medical device mergers and acquisitions (M&A).
Our Due Diligence and M&A Services Include:
- Comprehensive M&A Due Diligence Evaluations: Conduct detailed scientific and regulatory assessments to evaluate the strengths, weaknesses, and compliance status of potential acquisition targets.
- Independent Scientific Review & Advice: Deliver objective, expert advice to support your decision-making process and ensure alignment with regulatory requirements and business goals.
Partner with toXcel for reliable, expert due diligence services that empower confident mergers, acquisitions, and investments in the life sciences sector.
Veterinary Products
Effective development and regulatory compliance of veterinary pharmaceuticals and biologics are essential to ensuring animal health and meeting stringent agency requirements.
toXcel‘s Veterinary Product Services Include:
- Regulatory Strategy & Submission Support: Develop and implement regulatory strategies tailored for veterinary drugs.
- Program Development : Advise on nonclinical toxicology and safety studies specific to veterinary products.
- Compliance & Quality Assurance: Support Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliance, ensuring your studies meet FDA Center for Veterinary Medicine (CVM) and international regulatory standards.
- Labeling and Post-Approval Support: Assist with labeling development, regulatory reporting, and post-market compliance activities to maintain product safety and efficacy.
- Support for EPA-Regulated Pet Spot-On Products: Provide specialized regulatory guidance and product support for EPA-regulated pet spot-on treatments, including registration, testing, and label compliance.
Partner with toXcel for veterinary regulatory solutions that streamline product development, facilitate regulatory approvals, and promote animal health and welfare.
White Papers and Other Downloadable Resources
Whether your company is newly emerging or has extensive regulatory experience, the FDA drug approval process can be both costly and time-consuming…
Drug & Cosmetic Establishment Registration, Product Listing & Amount Reporting
The U.S. Food and Drug Administration has moved to electronic submissions for both Drug, and most recently, Cosmetic Facilities and products…
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