CMC GMP Facility Design
Delivering the full spectrum of Facility Design services
Alira Health CMC Team will work closely with you to design solutions tailored to your business needs and goals. Leveraging years of industry experience, we can:
- Facilitate design validation efforts for manufacturing, segregation, ancillary spaces, and critical equipment
- Assist and critique process flows, including process flow diagrams
- Identify and recommend waste systems and storage needs
- Oversee design elements for validation and regulatory compliance
Why choose Alira Health for GMP Facility Design?
Your dedicated Alira Health team can help design GMP facilities to support your project from concept through build and validation. As our partner, you can count on:
- Knowledgeable industry experts who deliver scalable, actionable insights
- In-depth experience with phase-appropriate facility requirements based on global regulatory agency interactions
- Compliance-focused guidance to support evaluation and facility planning and design for all spaces, utilities, storage, and personnel, process and waste flows
Look for our clinical development experts Chris Rao and Kenny Carberry as delegates onsite at MassMedic Regulatory Roundup.
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.
The EU Pharmaceutical Package: Impact on Orphan Medicinal Products
This article reviews the proposed changes in the EU Pharma Package for data protection related to orphan medicinal products (OMPs).
The EU Pharmaceutical Package: Regulatory Protection Changes
Our regulatory experts present a more detailed analysis of the proposed changes introduced to Regulatory Data Protection (RDP).
Medical Device Regulation: A Checklist for Preparation
This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
Access and reimbursement pathways for digital health solutions and IVD devices
Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular(...)