experience. expertise. execution.
PakLab’s tradition of constant evolution to meet market demands and to update processes to fit new capabilities allows us to provide services that define our brand as the choice CMO for mid-size and large companies. We welcome over 30 audits a year and will be happy to entertain your validation team.
PakLab is an FDA compliant facility. Our processes, standard operating procedures and test methods are designed according to good manufacturing practices, GMP training is conducted on a regular basis to ensure all work is carried out according to current procedures. OTC product validation work is performed in-house by industry experts. Challenge testing, assay analysis and method validation is also performed in-house to ensure product quality during each step of the process, from material receipt to finished good shipments.
PakLab offers testing in-house:
Customer audits are always welcome. We understand every brand is unique. Each of our suppliers is reviewed by our quality team to ensure every material that goes into your product meets your expectations. Even if a product requires a specialty material only available from a specific supplier, we will gladly qualify them as part of the Paklab supplier base.
PakLab is proud to have earned a variety of certifications:
- Gluten-Free Certified
- MRP System
- OTC Certified
- SOPs for GMP Compliant
- TGA Certified
- USP Grade Water Systems
- In-House Metrics & Analytics
- ISO 9001
- ISO 22716
- AIB Certified
- ASI Certified
- ATF Registered for Denatured Alcohol
- FDA Registered
- GTC Certified