Regulatory Affairs
Empowering Innovation with Regulatory Expertise
As the regulatory environment becomes increasingly complex, our global Regulatory Affairs services team offers a portfolio of integrated solutions for every stage, from clinical development to registration and lifecycle management, to help biopharma companies accelerate life-changing therapies to patients worldwide.
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Offering a full range of regulatory compliance solutions
Clinical
- Agency meetings
- US and China IND authoring, submission and maintenance
- EU IMPD authoring and submission
- Gap analysis
- Expedited programs
- Device evaluations
Development
- Scientific advice and Agency meetings
- Orphan drug designations
- PIPs/PSPs
- Pre-submission meetings
- Global development plans
- Regulatory accelerated pathways
Application
- NDA / BLA / MAA / 505(b)1 authoring and submission (including non-clinical, clinical)
- Health authority questions and commitments
- ANDA submission and maintenance
- 510K authoring and submissions
Regulatory Operations
- Global publishing to 175 markets
- RIM data entry
- QC and data management
- IDMPs
- RIM transfer and remediation
- Labelling, PIL testing
- US Agent Services
Regulatory
- Regulatory strategy
- Labelling creation
- Labelling variations and artwork
- Safety variations
- Global MAA expansion
- Medical device assessment
Chemistry, Manufacturing & Control (CMC)
- CMC strategy and Module 2.3/3 authoring
- Variations, site transfers
- Annual reports and renewals
- MAT changes
- Administrative amendments
- Line extensions
Partnering with purpose
We tailor our regulatory affairs services to your product and specific requirements by implementing custom processes and technologies, drawing on diverse therapeutic expertise and accessing commercial insights – all to facilitate the design and execution of more efficient studies and improve the likelihood of your regulatory and commercial success.
We partner with purpose, supporting you with:
A Dedicated Regulatory Affairs Team
We are a team of over 300 regulatory experts spread across the globe providing you with “follow-the-sun” support across all stages of the product lifecycle, from proof of concept, pre-approval and license application, to post-approval, lifecycle maintenance and market exit.
Expert Guidance and Support
We provide strategic advice addressing regulatory concerns, interpreting regulatory guidelines and ensuring compliance with applicable regulations.
Documentation Review and Preparation
Our team prepares comprehensive responses that address regulatory questions thoroughly and provides supporting evidence when necessary.
Communication with Regulatory Authorities
We maintain open lines of communication and foster positive relationships with regulatory agencies to facilitate dialogue and issue resolution.
Compliance Monitoring and Risk Management
We monitor regulatory compliance and proactively identify any potential issues or areas of concern. Our team assesses regulatory risks and develops mitigation strategies to minimize the impact on regulatory approval timelines.
Transparency and Proactive Problem Solving
We conduct post-response evaluations to identify lessons learned and opportunities for improvement in a process to enhance efficiency, effectiveness and compliance
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