Alira Health

Alira Health

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

News June 18, 2024
Alira Health Partners with Scottsdale Research Institute for Psilocybin Clinical Trials Funded by the State of Arizona
Alira Health, a global advisory and clinical research firm, announced today its collaboration with the Scottsdale Research Institute (SRI) to provide comprehensive regulatory and clinical(...)
Clinical Trials Regulatory
Case Studies May 8, 2024
Mid-Size Medtech Company with a Borderline Product Defines Strategy for EU Launch
Medtech company sought support in developing a regulatory strategy for the EU launch of their product with an aggressive timeline to launch.
Medical Devices MedTech Regulatory
Events April 30, 2024
The MedTech Forum 2024
We are thrilled to announce that we will exhibit and speak at The MedTech Forum 2024.
MedTech Regulatory
Articles April 17, 2024
The Challenges for Medtech in a Complex Regulatory Landscape in 2024
Learn more about what manufacturers in the US and Europe should consider when developing their regulatory strategies and prioritizing their target markets from regulatory affairs expert Mercè Guerra.
Medical Devices MedTech Regulatory
Events February 21, 2024
XXII Conferenza Nazionale Sulla Farmaceutica
Meet Giovanni Firenze, Partner Consulting Italy, onsite in Catania and learn more about the impact of the new AIFA reform.
Italy Regulatory
Events September 28, 2023
Regulatory Roundup
Look for our clinical development experts Chris Rao and Kenny Carberry as delegates onsite at MassMedic Regulatory Roundup.
MedTech Regulatory
Reports September 22, 2023
Impact of the New EU HTA Regulation on Access to Innovative Medicines in Europe
In this interview, Alira Health Partner Chus Castillo gives updates on HTA Regulation, related challenges, and potential effect on access to innovative medicines.
Biotech Healthcare Technology Regulatory Spain
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.