Pearl BioPharm Solutions
Our Services
Commissioning, Qualification, & Validation (CQV)
- Providing comprehensive, systematic, collaborative engineering and quality driven commissioning services for pharmaceutical, biopharmaceutical, medical devices and other regulated industries.
- Qualification of facility, utility, equipment, systems and computer systems providing assurance that the systems perform per design requirements and specifications, helping with both science and risk-based approaches.
- Supporting all aspects of process validation to assure that systems, processes and methods meet pre-determined requirements.
Technical Services
Providing consulting services for all aspects of technical services from new product introduction, development, scale-up, and technology transfer in support of clinical and commercial products across several dosage forms for
- Sterile Fill Finish
- Cell and Gene Therapy
- Drug and Drug-Device Combination
- Liquid Oral Dosage Forms
Quality & Compliance
We are available remote or on-site assistance to discuss and consult with your Quality teams to support all aspects of Quality and Compliance from
- Training
- Good Documentation
- Investigations
- Quality Risk Management
- Gap Assessments against Regulatory (FDA, EU GMP, ICH guidelines).
Special Projects
- We provide support for complex problems and strategic initiative which requires in depth analysis, collaboration, decision making within defined procedures and practices.
- We are available to consult with you or your staff and provide necessary cGMP solutions.
- We are available for remote or on-site assistance.