Regulatory Support Services for Pharmaceutical Development

Pharmaceutical Development or Technology Transfer projects must meet ever increasing regulatory requirements in a complex market landscape.

At Aenova, our regulatory experts and our development and MS&T scientists develop and execute detailed strategies for your product, providing a clear path forward through all critical milestones to help you achieve a successful outcome with regulators.

To streamline approval times, our approach ensures that development efforts are focused on generating complete and relevant datasets required for approval to prevent costly delays caused by missing or inadequate data.

We help minimize post-authorization CMC changes by managing the level of detail in the registration dossier and leveraging the flexibility offered by ICH Q8, Q10, or Q12 guidelines. Additionally, we support updating outdated dossiers through GAP analysis, dossier updates, variation strategies and filing to prepare for new marketing authorization applications.

Comprehensive Regulatory Services

We support your pharmaceutical regulatory strategy with a full range of services, including:

Product Development

• Support of development projects to ensure that all regional regulatory requirements are considered
• Determine the most appropriate application type for a market authorization application with respect to clinical data requirement and time-to market (e.g. full / mixed / hybrid / well-established use / generic dossier)
• Analyse opportunities for study waivers (BCS-classification, use of in-vitro systems) and writing of biowaiver justifications
• Support development strategy (size and number of batches, stability designs, setting of specifications)
• Alert on new and relevant upcoming regulatory requirements
• Compile regulatory expert statements (e.g. module 2.3)
• Provide appropriate IMPDs and conclusive registration documentation in eCTD format ready for filing
• Professional management of corresponding regulatory procedures (such as: filing, tracking, responses to deficiency letters)

Clinical Studies

• Review of study protocols and study reports
• Compilation of IMPDs in eCTD format
• Managing of clinical trial applications

Product Life Cycle Management

• Categorize post approval CMC changes, describe data requirements and associated authority review times on a regional basis
• Prepare post-approval change management protocols in close interchange with production site, analytical site, Q.P. and MAH
• Compile corresponding variation documentation ready for regulatory submission (description of changes, justifications, expert statements, eCTD sequence)
• Manage regulatory variation procedures

Technology Transfer

• Determine the most efficient regulatory variation strategy and define related data requirements
• Provide corresponding justifications and expert statements
• Compile variation documentation parallel to transfer activities
• Manage regulatory variation procedures

Global Reach, Local Expertise

At Aenova, we provide pharmaceutical regulatory support to ensure compliance, efficiency, and market success. With extensive expertise in global regulatory requirements, we assist pharmaceutical companies in navigating complex approval processes, from early-stage development to market authorization.

Our end-to-end solutions include method development, validation, stability testing, and regulatory documentation, all designed to meet stringent international standards. We work closely with clients to tailor our approach, ensuring seamless integration with their development and manufacturing processes.

Additional Development & Technology Services

At Aenova, we provide a wide range of development and technology services for pharmaceutical companies.

Drug Product Development

Clinical Trial Supply Management

Regulatory Support

Analytical Development

Contact Us

Looking for expert regulatory support to navigate complex compliance requirements with confidence? Aenova provides industry-leading solutions to ensure the highest standards of safety, efficacy, and regulatory compliance.

Get in touch with our team today for expert guidance and consultation on your regulatory needs.

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