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Streamlining Chemistry, Manufacturing, and Controls (CMC) to Accelerate Drug Development
Accelerate drug development with tailored CMC solutions that streamline processes, ensure quality and stability, and maintain regulatory compliance every step of the way.
Navigating the complexities of drug development requires specialized expertise, especially when it comes to Chemistry, Manufacturing, and Controls (CMC). At ARSI Canada, our CMC consulting services are designed to help pharmaceutical and biotech companies bring their products to market faster and more efficiently while ensuring regulatory compliance at every step.
Our expert CMC consultants provide tailored solutions that address the unique challenges you face in drug development. From developing robust manufacturing processes to ensuring the quality and stability of your product, we are your trusted partner in driving success throughout the entire product lifecycle.
What is CMC Consulting?
CMC (Chemistry, Manufacturing, and Controls) consulting involves comprehensive support in the development, manufacturing, and control of drug substances and products. This includes everything from formulation development, process optimization, and quality assurance to ensuring compliance with regulatory submissions like INDs (Investigational New Drug) and NDAs (New Drug Applications).At ARSI Canada, our CMC experts integrate seamlessly with your team to provide data-driven strategies, helping you avoid potential challenges early in the development process, saving both time and costs.
Our Formulation Development Consulting Services
At ARSI Canada, we cover a broad spectrum of CMC-related activities, ensuring that your products meet the highest standards of quality and regulatory compliance.
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Our experts work with your team to create a customized pharmaceutical development strategy, designed to ensure that your product meets regulatory requirements while remaining commercially viable. We focus on:
Development and Manufacturing Strategy: Crafting a roadmap that aligns with both short-term and long-term business goals.
Risk Management: Identifying potential risks in the early stages of development and implementing mitigation strategies.
Technical and Regulatory Guidance: Ensuring that all technical aspects of development, including formulation and process controls, are aligned with regulatory expectations.
We provide extensive regulatory support for your CMC submissions, ensuring that your product meets all necessary regulatory guidelines for approval. Our services include:
IND and NDA/BLA Preparation: Assisting with the preparation of CMC sections for IND and NDA/BLA submissions, ensuring that all required data is comprehensive and compliant.
Agency Interactions: Facilitating communication with regulatory agencies (FDA, EMA, Health Canada, etc.) to streamline the approval process.
Post-Approval CMC Updates: Supporting ongoing compliance by updating CMC documentation post-approval, as required.
Maintaining a high standard of quality throughout drug development is critical to your product’s success. Our team helps you establish and maintain a robust Quality Management System (QMS) that meets both regulatory and operational requirements.
cGXP Compliance Audits: Conducting thorough audits to ensure compliance with current Good Manufacturing Practices (cGMP) and other applicable regulations.
Pre-Approval Inspections: Preparing your team for regulatory pre-approval inspections to ensure a smooth process.
Ongoing Quality Control: Implementing quality control measures to maintain product integrity and safety throughout development and production.
A well-structured supply chain is essential to meeting production timelines and ensuring product quality. We help you build and optimize your supply chain from the ground up:
Upstream Supply Chain Planning: Ensuring that raw materials and components are sourced efficiently and meet quality standards.
Downstream Supply Chain & Distribution Licensing: Helping you navigate the complexities of global distribution, including Good Distribution Practices (GDP) compliance and licensing.
Whether you're seeking investment, partnerships, or M&A opportunities, thorough CMC due diligence is essential for making informed decisions. Our team assists with:
Technical Reviews: Conducting detailed technical reviews of your CMC data to assess development risks and opportunities.
Compliance Checks: Ensuring that your CMC documentation and processes meet all regulatory and industry standards.
Strategic Recommendations: Offering expert guidance on how to optimize CMC-related aspects of your development for successful business transactions.
Our CMC Consulting Capabilities
- Pharmaceutical Development Strategy: A roadmap that integrates regulatory compliance, cost management, and commercial viability.
- Regulatory Submissions (IND/NDA/BLA): Expert preparation of the CMC sections for IND, NDA, and BLA filings, along with ongoing support for post-submission queries.
- Quality Management Systems (QMS): Ensuring that your processes comply with cGMP and other regulatory standards, while also preparing for pre-approval inspections.
- Supply Chain & Distribution Planning: Optimizing both upstream and downstream supply chains, ensuring GDP compliance and efficient product distribution.
- Due Diligence for BD Transactions: Providing technical and regulatory insight to support investment, M&A, or partnership decisions.
Why Choose ARSI Canada for CMC Consulting?
Partnering with ARSI Canada for CMC consulting means you’re choosing a team with a wealth of industry knowledge and a proven track record of helping companies navigate the complexities of drug development. Here’s why we stand out:
- Comprehensive Expertise: Our team includes experts with decades of experience in pharmaceutical development, regulatory affairs, and quality management.
- Data-driven Solutions: We use data and scientific insights to develop CMC strategies that are not only compliant but also optimized for efficiency and cost-effectiveness.
- Integrated Approach: Our CMC consultants work closely with other disciplines, such as regulatory and formulation teams, to ensure a unified strategy for your product’s success.
- Customized Strategy: Every client is unique, and so are our strategies. We tailor our CMC services to meet your specific project needs, ensuring that you receive the most relevant and actionable advice.
Industries We Serve
Developing new chemical entities (NCEs) and needing robust CMC strategies to ensure success in clinical trials and regulatory submissions.
Transitioning research into viable pharmaceutical products with limited resources and needing expert guidance.
Working with complex biologics and needing specialized CMC expertise.
Navigating the challenges of creating bioequivalent products with efficient CMC processes.