ProStructive Associates' staff has experience in a broad range of pharmaceutical and biotech manufacturing projects, including oral solid dosage, sterile liquids, radiopharmaceuticals, creams and ointments, and vaccines, and we are experienced with Canadian, American and European regulatory environments. With this background, we ensure that projects will meet regulatory requirements and we provide specific expertise in the areas of:
- GMP Impact Assessment
- Qualification and Validation
- Enhanced Design Review
- Development of SOPs
