C3 Consulting Inc. clients are in the life science industries—pharmaceuticals, biologics, and medical devices. They range from Fortune 500 global conglomerates with operations in many countries to private equity firms to small, family-owned enterprises with novel new healthcare products. Clients reach out for our expert counsel on various topics ranging from quality systems to regulatory strategy or assistance in new product development. Sometimes C3 Consulting Inc, is called upon by companies planning for the next audit, inspection or expanding distribution to new countries requiring regulatory submissions. Other times, clients seek C3 Consulting Inc. assistance when remediation is required.  In all scenarios, C3 Consulting Inc. delivers results that inspire confidence, generate sustainable compliance strategies and loyalty from our clients.

A Sampling of Projects that C3 Consulting has Engaged In:

Vaccine Manufacturer: Based on consent decree, consulting activities focused on validation and qualification project for the laboratories, warehouse and segments of manufacturing based on construction of new facilities.

Parenteral manufacturer for CNS drug (both injectable and tablet form): C3 Consulting created and implemented the core quality systems (both GMP and GCP) for combination product (drug/device) during the early stages of Phase III clinicals as to prepare for the NDA submission.

Major manufacturer of parenterals for anesthesia, cardiology, electrolytes, pain and nutritional: Remediation project for the company under consent decree. C3 Consulting reviewed adverse events, complaints and CAPA systems and records as related to the company’s investigations. Performed remediation’s and corrective actions with cross functional groups as related to gaps. C3 Consulting was responsible for the initiation phase of recalls and field alerts.

Specialty Vaccine Manufacturer: based on series of 483s received by the manufacturer, the C3 team performed a gap analysis of the chemistry, biology, and microbiology labs along with the vivarium. Worked with cross functional groups in the laboratories to correct major issues with:

  • test method validation process,
  • qualification of instruments,
  • process for animal safety testing,
  • and facility gaps in the vivarium.

Plasma manufacturer (albumin and clotting factors): Remediation project for the company under consent decree. Implementation of the quality systems within the manufacturing and the laboratories as related to the new Validation Master Plan.

Medical Device Manufacturer for International Blood Banking Software: The C3 team created and implemented the quality systems per Part 820 and ISO 13485. C3 Consulting functioned as their Quality and Regulatory Management until the systems were implemented and 510k submitted.

Medical Device Manufacturer of Class II and III Dental Devices: C3 Consulting brought in to implement system and processes for risk management and design control. during this time also achieved approval for sell of the various dental products in Japan and South America-Brazil.

Drug Substance manufacturer for oncology products and excipients: Improvement project in relation to the company’s current quality systems. Implemented a comprehensive risk management program, process for root cause analysis and supplier management program.

Contract Medical Device Manufacturer for International Products: Class I and II devices: C3 Consulting implemented the quality systems and lead the organization in obtaining ISO 13485 certification.

Contract manufacturer for Biologics: The C3 Team assisted client in solving issues with manufacturing problems in relation to the production of an injectable biological product. Additionally, created new processes for the training of production personnel in relation to the high number of nonconformances in the product formulation and filling/packaging process.