Our deep understanding of global regulatory frameworks enables us to anticipate challenges and streamline processes, saving you time and resources while mitigating risks.
What can we do for you?
We specialize in delivering comprehensive regulatory support throughout the CMC (Chemistry, Manufacturing, and Controls) development phase to ensure your drug meets regulatory requirements and achieves timely approval.
- Gap Analysis: Identify and address gaps in your CMC data and processes (see also CMC gap assessment).
- Roadmap Creation: Develop a strategic plan for your regulatory submissions and interactions with health authorities (see also Strategic Regulatory Advice).
- Submission Preparation: Prepare and compile essential documentation for your regulatory submissions to ensure they are submission ready (see also Submission Preparation Support).
- CMC Sections of IND/IMPD/NDA/BLA/MAA: Author high-quality CMC sections, including module 2.3 and 3 of the CTD (Common Technical Document) (see also CMC Technical Writing).
- Regulatory Filing: Submit CMC sections as part of your regulatory submissions to health authorities (FDA, EMA, etc.) (see also Electronic Submission support).
- Response to Regulatory Queries: Address questions and requests for additional information from regulatory agencies.
- Change Control: Assess changes in your manufacturing processes and ensure regulatory compliance.
- Post-Approval Submissions: Support the preparation and submission of post-approval change requests (see also Life Cycle Management).
- Stay up-to-date: Monitor and interpret current regulatory guidelines, industry standards, and best practices.
- Meeting Preparation: Prepare for and facilitate meetings with regulatory agencies (e.g., FDA pre-IND meetings, Scientific Advice meetings with EMA).
- Regulatory Advocacy: Act as a liaison between your company and regulatory bodies to advocate for your product.
- Risk Management: Identify potential regulatory risks and develop mitigation strategies.
- Contingency Planning: Prepare for potential regulatory hurdles and develop backup plans.
- Internal Training: Provide training on regulatory requirements, best practices, regulatory impact of Quality by Design (QbD) principles, and regulatory impact of Good Manufacturing Practices (GMP).
- Ongoing Support: Offer continuous support throughout the CMC development process, ensuring alignment with regulatory expectations, QbD principles, and GMP standards from a regulatory perspective.
We are committed to fostering successful partnerships with our clients, delivering solutions that are both innovative and compliant. Whether you are navigating regulatory submissions, managing compliance issues, or optimizing manufacturing processes, our team is here to empower your success.
Explore how our specialized expertise can accelerate your path to regulatory approval and market entry. Contact us today to discover the difference we can make in your CMC drug development journey.
Approach & Expertise
Learn how we can support you in meeting your business goals
- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.
Questions from our clients
FAQ Section
Regulatory support during CMC (Chemistry, Manufacturing, and Controls) development is crucial for ensuring a smooth approval process for IND/IMPD and MA/BLA dossiers. Support can vary from guidance of validation requirements for analytical methods, assure that your reference standards comply with regulatory requirements or provide input on key development milestones and ensure they align with regulatory timelines and expectations.
Having a regulatory strategy in place during CMC development offers several benefits:
- Streamlined Development Process: A well-defined regulatory strategy helps streamline the development process by providing a clear roadmap and timeline for regulatory submissions and approvals.
- Risk Mitigation: Identifying potential regulatory risks early and developing mitigation strategies to avoid delays and non-compliance issues.
- Efficient Resource Allocation: Ensuring that resources are allocated efficiently to address critical regulatory requirements and priorities.
- Proactive Regulatory Engagement: Facilitating proactive engagement with regulatory authorities to address any concerns and receive guidance throughout the development process.
- Improved Compliance: Enhancing compliance with regulatory standards and guidelines, ultimately increasing the likelihood of successful approval and market entry.