Regulatory Strategy Development
- We work closely with your team to develop a robust regulatory strategy that aligns with your business goals and product timelines.
Regulatory Pathway Analysis: We analyze the most suitable regulatory pathways based on the nature of your product and the markets you wish to enter, helping you make informed decisions.
Market Entry Strategies: Tailored strategies for navigating market authorization processes across different regions, including FDA, and other regulatory agencies.
Risk Mitigation and Gap Analysis
- We provide in-depth risk assessments to identify potential regulatory hurdles and gaps in your current processes. Our experts recommend corrective actions to ensure compliance and reduce the likelihood of delays or costly non-compliance.
- Regulatory Gap Analysis: We conduct thorough audits of your existing regulatory processes to identify weaknesses or gaps and provide actionable recommendations
- Regulatory Risk Management: Our team helps you anticipate potential regulatory challenges and develop strategies to mitigate risks effectively.
Regulatory Affairs and Market Intelligence
Our team provides valuable insights into the latest regulatory developments and helps you adapt to evolving global requirements.
Regulatory Intelligence: We provide up-to-date information on regulatory changes and industry best practices to help you stay ahead of the curve.
Market and Competitor Analysis: Our consulting team conducts market analysis to provide a comprehensive understanding of your competitive landscape and regulatory requirements in target markets.
- Documentation & Certification Support
Our Documentation & Certification Support services are designed to assist pharmaceutical companies in navigating the complex regulatory requirements for product approvals and maintaining compliance throughout the lifecycle of their products.
Regulatory Dossier Preparation
- We offer comprehensive support in the preparation of regulatory dossiers for new drug applications, biologics, medical devices, and other pharmaceutical products.
- CTD (Common Technical Document) Submission: Assistance with preparing the CTD format for regulatory submissions, ensuring compliance with the requirements of the FDA, and other regulatory agencies.
- Regulatory Documentation for Global Submissions: Tailored support for creating the necessary documentation for submitting to multiple health authorities worldwide, including the U.S. FDA and other global regulatory bodies.
Labelling & Packaging Documentation
- We offer comprehensive support for creating and reviewing product labelling and packaging documentation to ensure compliance with regulatory guidelines.
- Labelling Compliance: Assistance with labelling requirements across multiple jurisdictions to ensure that your product labels are compliant with local regulations and industry standards.
- Packaging Review: We ensure that packaging materials meet regulatory guidelines for safety and quality, while also providing guidance on required documentation for product packaging.
Post-Approval Variations and Documentation Updates
- After obtaining market approval, it is critical to manage post-approval variations and maintain accurate documentation for continued compliance.
- Post-Approval Changes: We assist with the preparation of documentation related to changes in the product, manufacturing process, or labelling that require regulatory approval.
Periodic Documentation Reviews: Ongoing support for maintaining up-to-date documentation to ensure continuous compliance with evolving regulatory requirements.