Bioquest is synonymous with proven solutions and unparalleled quality, guaranteeing the successful execution of regulatory services globally. Our seasoned regulatory affairs specialists guide you through the comprehensive drug development and regulatory submission journey to achieve your regulatory objectives.
Bioquest provides an extensive array of Regulatory Services, encompassing..
- Provides regulatory assessment and support.
- Evaluates and assesses regulatory impact of proposed product changes.
- Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development teams.
- Provides project team representation and direction in managing information from/to other departments regarding regulatory submissions.
- Support product development teams by interpreting and strategically applying regulations, guidances and available research/information.
- Plans, prepares and submits varied regulatory filings and correspondence to FDA and other appropriate Health Authorities. Keeps to internal and federal timelines and ensures content, quality, accuracy and format of submissions comply with applicable laws, regulations and corporate standards.
- Critically reviews all types of documents for regulatory submission, including product labeling and promotional and advertising material.
- Conducts regulatory intelligence as required for in-licensing candidates and products in development.
- Ensures that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current regulatory requirements.
- Maintains awareness of all current, pertinent regulations, guidelines, policies, procedures and practices. Analyzes changes and updates and advises and provides recommendations.
- Enhances implementation of eCTD system by restructuring document format with new submissions.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
- Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
