Regulatory: Pharma

CMC Regulatory Affairs and Quality Management

Rely on an experienced quality and regulatory support team

Alira Health CMC fully understands the complex regulatory challenges of drug development and provides in-depth guidance across all quality processes and CMC regulatory affairs. We can:
  • Design quality management systems, including the creation of SOPs and execution of vendor audits
  • Lead and participate in global regulatory interactions
  • Create and recommend regulatory strategies
  • Generate responses to agency requests, comments, and questions
  • Author and maintain global regulatory dossiers
  • Generate and maintain Quality Agreements
  • Engage authors to prepare pre-IND briefing package and CMC section of IND/IMPD/BLA

Why choose Alira Health for your CMC Regulatory Affairs?

Our global team has significant industry experience providing guidance to meet evolving global CMC regulatory guidelines. Our dedicated team provides:

  • Strong, in-depth knowledge of quality processes and compliance across all stages of biotherapeutic development
  • Excellence in drafting and negotiating quality agreements
  • High volume experience in global regulatory submissions and documentation, including generation and modification

Related CMC Regulatory News

Publications January 19, 2023
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
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Publications January 11, 2023
Regulatory Strategy for Registering Rare Disease Products in the EU: What You Need to Know
Given that the regulation is likely to change considerably, drug developers may need to revisit their development strategy. In the meantime, building a strategy around these evergreen(...)
EU Rare Disease Regulatory
Publications December 21, 2022
2022 Recap: Your Favorite Alira Health Publications
In 2022, the Alira Health team of scientists, strategists, economists, clinicians, and biostatisticians shared actionable insights, industry thought leadership, and leading-edge guidance(...)
Clinical Digital Health Market Access MedTech Pharma Regulatory
Multimedia December 17, 2022
Webinar Replay: Partnering with Patients to Streamline Trial Operations: Protocol to Regulatory Submission in 60 days
Learn how patients and patient advocacy organizations can be directly enabled as powerful partners to facilitate all stages of DCT deployment, from protocol design, recruitment, engagement(...)
Clinical Trials Patient Centric Regulatory
Publications November 22, 2022
External Control Arms: The Way to Go?
The growing implementation of Single Arm Trials (SATs) with External Control Arms (ECAs) has been the subject of heated debate across Europe.
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Events October 7, 2022
Debate Sobre los IPT en Oncología
We are pleased to announce our next event, “Debate Sobre los IPT en Oncología,” focusing on price and reimbursement (P&R) of vital oncology and oncohematology therapies.
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Events October 6, 2022
The MedTech Conference 2022
We are pleased to share that we will be joining the MedTech Conference 2022 as sponsors and speakers! This year’s edition will have more than 100 sessions focusing on today’s hot topics.
M&A MedTech Regulatory
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