Embark on your biosimilars journey with confidence and let Asphalion guide you through every step of the way. Our extensive expertise in Chemistry, Manufacturing, and Controls (CMC) ensures that your biosimilars not only meet regulatory requirements but also stand out in the market. Here’s how we can facilitate your biosimilars journey from development to post-approval activities and beyond:
Early CMC Development:
- Regulatory Strategy Development: Tailored regulatory strategies considering regional requirements (US, EU, Canada, Japan, Australia).
- Quality by Design (QbD) Implementation: Incorporating QbD principles into product development for enhanced quality and efficiency.
- Manufacturing Process Characterization: Development, optimization, scale-up, and validation of manufacturing processes ensuring reproducibility and scalability.
- Risk Management: Implementing risk management strategies to identify, analyze, and mitigate risks associated with biosimilar development and manufacturing.
- Analytical Method Development: Support in developing robust and reliable analytical methods suitable for biosimilar analysis.
Clinical Development:
- Regulatory Pathways: Guidance on regulatory pathways and requirements for high regulated markets.
- Manufacturing Scale-Up: Assistance in scaling up manufacturing processes from laboratory to commercial scale.
- GMP Compliance: Support in ensuring compliance with Good Manufacturing Practice (GMP) and other relevant regulatory guidelines.
Marketing Authorization:
- Regulatory Submissions: Preparation of CMC sections for regulatory submissions (MAAs, BLAs) and support in electronic submissions.
- Analytical Comparability: Guidance on designing and conducting analytical comparability exercises pre- and post-manufacturing changes.
- CMC Change Control: Preparation, assessment, and management of CMC change controls.
Post-Approval Activities:
- Post-Approval Changes: Strategy, writing, and submission of post-approval changes including variations and supplements.
- Analytical Comparability Exercises: Guidance on conducting analytical comparability exercises related to proposed post-approval changes.
General CMC Support:
- Gap Analysis and Due Diligence: Assessments and due diligence to identify gaps and ensure compliance.
- Scientific Advice and Pre-Submission Meetings: Assistance in scientific advice meetings and pre-submission meetings with regulatory authorities.
- Project Management: Comprehensive project management to ensure timelines and deliverables are met.
- Tailored Training: Customized training sessions and workshops on biosimilar CMC regulatory topics.
Partner with Asphalion and unlock the full potential of your biosimilars. Let’s pave the way for innovation and accessibility in healthcare together. Contact us today to learn more!
Have a look at the complete solutions we can provide you with: Asphalion CMC solutions for Biosimilars
Contact us for further information or queries: [email protected]
