Compliance

Safety Reporting: Regulations for combination product safety reporting were expected in 2012. During the transition period, combination product manufactures will need to exhibit reasonable diligence in complying with applicable predicate rules for drugs, biologics and medical devices. Chimera assists manufactures in developing policies and procedures for diligent compliance with predicate rules for drugs, biologics and medical devices and will assist manufacturers and marketers of combination products in restructuring their vigilance systems to comply with new safety reporting regulations. Chimera also conducts audits of safety reporting systems to assure appropriate ongoing compliance and diligence in properly reporting safety issues for combination products.

Quality Systems: Quality system requirements for combination products changed in 2012. Compliance is based on proper utilization of both the CGMP and QSR predicate rules. On the basis of its experience, Chimera assists manufactures in designing quality systems and developing policies and procedures to enable compliance with predicate rules that evidence a properly designed quality system for development and manufacture of combination products. Chimera is especially adept in assisting manufacturers with identifying needs, planning and implementing device design controls (including product design validation/human factors studies) in a pharmaceutical development and manufacturing environment. Chimera also conducts audits of quality systems of manufacturers, vendors and contractors to assure ongoing compliance with regulatory requirements and combination product quality assurance Chimera can assist in planning and implementing remediation of quality system deficiencies.

Inspections: Chimera assists manufacturers in preparing for FDA inspections through mock-auditing and gap assessments and Chimera can assist manufacturing operations and site quality assurance functions, either behind the scenes or in a liaison role, during FDA inspections.