Regulatory Assistance
Quality Control Services
Microbiology
Coldstream Laboratories Inc. has a full-service microbiology laboratory onsite. Microbiology testing services include bacterial endotoxin, sterility, and microbial limits.
Stability / Process Testing
Stability
Coldstream Laboratories Inc. offers complete Drug Product and API stability testing programs. We recognize that successful stability program implementation is dependent on client-focused communications and review of regulatory requirements. All storage conditions are validated. We have immense analytical experience with GMP/ ICH compliance programs. Our services include, but are not limited to:
Validated Stability Chamber Conditions:
- -20°
- 2-8 °C
- 25°C/ 60% RH
- 40°C/ 75% RH
- Photostability Chamber
Protocols:
- Long-term Stability
- Accelerated Stability
- Photostability
In Process and Release Testing
QC Release Testing for raw materials and finished products
Regulatory Assistance
Coldstream Laboratories provides all of the necessary regulatory assistance to support your project. We can help facilitate your submission and guarantee that your project is developed and registered in a timely and cost-efficient manner.
Our experienced Quality & Regulatory Affairs team can assist you with:
- Preparing for FDA-sponsor meetings
- Submitting marketed and investigational drug substance and drug products
- Writing CMC documents and review services
- Understanding expectations in working with regulatory authorities
- Identifying your unique options in developing regulatory strategies
24 Hour Document Availability
All CLI customers have 24-hour-a-day access to project documents in CMC or IMPD Indexed format as they are completed through a secure web interface.