Life Sciences Division
When it comes to connecting Medical Device, Pharmaceutical and Biotechnology clients with the most talented resources in the market, look no further than American Contract Group. With over 30 years’ experience within the technical contracting industry, ACG brings a new dynamic to client/contractor relationship building.
Having the correct technical talent in place is imperative, but what is equally important is that of culture matching. By providing resources that not only match the clients technical needs, we additionally focus on providing those that fit the clients internal culture, so that projects run smoothly, which creates an open forum of communication for all involved.
In the event that your organization is launching a new product, enhancing existing product, remediating, receives a warning letter, and or is in consent decree; American Contract Group will have the necessary resources to address these situations within Quality, Validation, and Regulatory areas.
Here are the core capabilities of our Life Sciences Division in terms of skill set and resource background:
Remediation, Engineering, Investigations; Gap Assessment, Risk Management, Design Control, CAPA, NCR, Complaint Handling and MDR’s, Internal and External Auditing.
Process, Equipment, Cleaning, CSV, Packaging, and Test Method Validation Writing and Executing of IQ, OQ, and PQ Protocols, Quality Oversight, Project/Program Management
Submissions, Pre-Market and Post Market Approval, CMC, CE Marking, NDA/IND, 510K, Country/Product Registrations, and Global/International Filing.
