Professional Specialties
Regulatory Submissions:
IND * IDE * 510(k) * PMA * NDA * ANDA * BLA * Intercenter Combination Products

Regulatory Compliance:
Closed loop corrective action program * Internal/supplier auditing to GMP/ISO standards * Customer complaint systems * Adverse events strategic planning * FDA action resolution * HACCP planning and microbiological control strategies * Warning letter corrective action planning * State drug/device manufacturing license inspection preparation

Quality Systems:
Device/drug quality programs establishment * ISO 9000 series compliance/technical files * Laboratory standards development * Standard operating procedures * Training programs (GMP/ISO)

Validation:
Facilities design, development, and review * FDA reviews * IQ/OQ/PQ – protocols, data generation and reports * Process validations – synthesis, propagation, formulation, sterilization and aseptic processing * Utilities specification development and validation – water systems (WFI), HVAC, pure steam, high purity gases, product piping, CIP and SIP systems * Equipment procurement (new and used) and validation

Product Development:
Prototype evaluation, engineering studies, bench testing * Market evaluation and analysis * Competitive benchmarking * Clinical utility models * Product pricing strategy development * Technical sales training materials.

Analytical Laboratory Support:
Chemistry and microbiology procedures * Method validation protocols * Packaging integrity studies * Environmental monitoring/testing