CDMO Selection and Outsourcing Support
Our technical experts help you develop and execute your clinical CMC strategy
Partner with our experienced CMC team to find, evaluate, and select a CDMO that fits your needs. We create tailored evaluation criteria focused on your product and strategic business priorities.
- Identify, evaluate, and select CDMOs based on the product profile and your company’s priorities
- Review and help negotiate master services agreements
- Provide technical oversight of the CDMO and advocate on behalf of the client to deliver clinical product on time
- Provide Quality oversight of all GMP operations
- Provide Regulatory/CMC strategy and advice captured and delivered in a dossier for FDA or EMA
We also support and oversee the following processes:
- Cell line, process, and formulation development
- Development and validation of analytical methods for in-process, release, and stability testing
- Design specifications for release of bulk drug substance and products
- GMP Drug Substance and Drug Product manufacturing
- Clinical packaging, labeling, and distribution
- Project Management
- Commercial manufacturing
Why choose Alira Health for CDMO selection and oversight?
As our client, you can rely on our dedicated, knowledgeable team to lead and support your outsourcing activities. You’ll benefit from our:
- Strong technical management at all stages from preclinical process development through manufacturing
- Commitment to client advocacy with vendors that drives holistic solutions tailored to your business needs and goals
- Full spectrum development support from product decision through clinical trials, process validation, and commercial manufacturing
- Packaging, labeling, and shipping support and management
CMC Outsourcing News
The 2024 Global Medtech Contract Manufacturing Report: Executive Summary
Alira Health Releases The 2024 Global Medtech Contract Manufacturing Report
Alira Health announced the release of the 2024 Global Medtech Contract Manufacturing Report. This report offers a comprehensive analysis of trends in the global medtech contract manufacturing(...)
The 2024 Global Medtech Contract Manufacturing Report
Discover the trends in the world of medical device CDMOs and their meaning for the industry in 2024 and beyond.
Medtech CDMO: Market and M&A Global Trends in 2024
This webinar replay investigates the current state of the global medtech CDMO industry and highlight Europe as a promising frontier for consolidation.
Alira Health’s CDD Supports Alcami Acquisition of Pacific Pharmaceutical Services
We are pleased to have been an advisor on Alcami’s acquisition of Pacific Pharmaceutical Services (PPS). Alira Health advised Alcami, a leading Contract Development Manufacturing(...)
Connect with our Drug Delivery Systems and CDMO experts Aude Ouensanga, Giulia Valsecchi, and Michal Raciborski on site at Pharmapack Europe.
MD&M West 2024
Join our Coffee Talk session “Global Medtech CDMOs: Update on Supply Chain Drivers and M&A Trends” on Tuesday, February 6 at MD&M West.