Sample
Projects
Following is a partial list of our successfully
completed projects and the types of companies who engaged us.
Quality System Implementation
- Finished pharmaceutical manufacturers
- Bulk drug/active pharmaceutical ingredient
(API) manufacturers
- Medical device developers and manufacturers
(e.g., surgical devices, imaging systems, cardiac monitoring systems,
instrumentation)
- IVD and investigational product developers and
manufacturers (e.g., kits and reagents)
- Software medical device developers and
manufacturers
- Sunscreen/OTC manufacturers
- Contract testing laboratories
Compliance Audits
- Medical device and IVD manufacturers (Quality
Systems compliance, design control processes, ERES)
- Finished pharmaceutical and bulk drug/active
pharmaceutical ingredient (API) manufacturers (Good Manufacturing Practices,
ERES)
- Software manufacturers (Design control
processes, validation practices, ERES)
- Contract testing laboratories (Good Laboratory
Practices, laboratory GMPs, software validation, ERES)
Software Validation, ERES, and Software Quality
Services
- Automated building management (environmental
monitoring) systems
- Chemistry analyzer software
- Blood Bank software
- Radiation treatment planning software
- Document management and control software
- Complaint, defect tracking and CAPA software
- Data acquisition systems (including clinical
data and HPLC testing)
- "Vanilla" and customized Commercial
Off-the-Shelf (COTS) software
Clinical Services (Audits, Protocol Review and
Medical Summaries)
- Biological products (examples: monoclonal
antibodies, activated lymphocytes, bioadhesives)
- Medical devices (examples: gamma-detecting
probe, blood filtration system, ovulation indicator)
- Topical pharmaceuticals (examples: anti-fungal
treatment, acne treatment)
- Oral pharmaceuticals (examples: anti-MS
therapeutic, Parkinson's disease therapeutic)
FDA Submissions
- Radiolabeled monoclonal antibody [IND]
- Generic topical tretinoin [ANDAs / CMC
Sections]
- Ocular diagnostic solution [505(b)(2)]
- Active pharmaceutical ingredients [US DMFs]
- Chemical medical device [US and EC DMFs]
- Blood bank software [510(k)]
- Gamma-detecting probe [510(k)]
- Brachytherapy accessory device [510(k)]
- Valve suction irrigator [510(k)]
- Patient support for charged-particle radiation
therapy system [510(k)]
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