Quality and Compliance

We bring a systems approach to GxP Quality operations.

We view Quality Systems as a proactive technical platform designed to minimize errors, reduce risk and improve product quality – rather than just a reactive policing program in place to detect wrong-doing.

We typically operate in teams – which includes close cooperation with cross-functional CMC expertise for GMP projects — as well as integrated GCP, GLP, GDP and/or GCP Quality Systems expertise. We have experience with products and their related Quality Systems requirements from early development through commercial stages across US, Canadian, European and various Asian GxP expectations.

GxP Quality Systems Management examples

  • Quality Systems leadership – our senior Quality experts can serve as your Quality Unit Management – up to and including the head of Quality (Learn more about outsourcing QA with RMC)
  • Development of customized Quality Systems master and enhancement plans
  • Quality consultation, strategy development and gap analyses
  • Supplier Quality Agreement negotiation on behalf of clients
  • Quality project management of GxP contract service providers

GxP Quality Assurance and Quality Control execution examples

  • Outsource Quality Assurance – our Quality experts can serve as your functional QA team (Learn more about outsourcing QA with RMC)
  • Planning and execution of Quality Assurance/Quality Control review projects
  • CAPA system development and/or tracking execution
  • Standard Operating Procedure (SOP) and change control system development and implementation
  • Training program development and providing on-site or distance training courses
  • Implementation and evaluation of Quality Control (GMP laboratory) systems
  • Identification, set-up and/or management of contract GMP manufacturers and laboratories
  • Development, evaluation and/or execution of stability programs
  • Validation services for GMP/GLP methods and equipment

GxP Regulatory and Compliance

  • Technical writing and/or review of communications with and submissions to regulatory agencies, including INDs/IMPDs/CTAs, NDAs/BLAs/MAAs, DMFs, and annual reports
  • Internal and external GxP Quality Systems audits according to US and EU regulatory requirements and/or unique client requirements (Learn more about RMC’s auditing programs)
  • Remediation Programs (e.g. for actions required from warning letters, partner audits, internal audits, etc.)
  • Mock inspections in preparation for regulatory, certification, or accreditation inspections

Outsourcing Quality Assurance with RMC

We have a number of highly experienced and effective Quality Assurance personnel available to help with:

  • Serving as sponsor’s Quality personnel for API and product manufacturing, control and release activities
  • Vendor, contractor and internal quality audits (see GxP Material and Service Supplier Audits)
  • Preparation and data verification of global regulatory submissions
  • Quality System design, creation and implementation and/or execution (policies and SOPs)

How are we unique?

  • We bring a systems approach to Quality operations, viewing Quality as a technical platform rather than just – reactive policing program in place to detect wrong-doing
  • Our staff are pragmatic and solutions-driven; we don’t just identify issues, we help resolve them
  • We operate in teams, offering both cross-functional CMC expertise as well as back-up staff to provide knowledgeable, reliable and cost-effective QA service

Why are we effective?

  • Global Pharmaceutical industry experience from development through commercial stages
  • Experience with US, European as well as Japanese and various Asian GMPs and integrated GxP expectations
  • RMC’s team of CMC professionals gives you seamless access to a wide knowledge base

Why consider QA outsourcing?

  • The ultimate approach to ensure independent quality oversight
  • Immediate access to experienced experts, with little or no learning curve required
  • Offers staffing flexibility without the expense and commitment of recruiting permanent hires
  • A way to easily expand staff capacity to address short-term surges – and just as quickly ramp down when the workload diminishes
  • Allows your internal staff to focus on core competencies or critical areas

Due Diligence Evaluations

  • Intellectual Property
  • Chemistry, Manufacturing, and Controls (CMC)
  • Facility Purchases
  • Commercial Launch Projections & Preparations
  • Quality / Compliance
  • Current Stage Evaluation & Relevancy
  • Master Planning & Resources
  • Commercial Preparation & System Integration

GxP Material and Service Supplier Audits

  • As directed by our clients, we execute internal and external GxP quality systems audits according to distinct local regulatory requirements including US, Canadian and/or EU requirements – or any other unique client requirements
  • GMP related audits include: drug product and API manufacturers; component, raw material and excipient suppliers; testing laboratories; labeling/packaging suppliers
  • GCP related audits include: CROs for study management, data management, safety management and Pharmacovigilance; clinical and bioanalytical labs; investigator sites
  • GLP related audits include: bioanalytical labs; full GLP non-clinical testing sites; GLP test article manufacturing sites
  • GDP related audits include: wholesalers; distributors; third-party logistics (3PL) providers
  • GVP related audits include: pharmacovigilance related service providers, including medical information service providers and call centers
  • Regulatory related: submission preparation service providers
  • We also conduct global mock inspections in preparation for GxP, CLIA, device, ISO or other related regulatory, certification, or accreditation inspections
  • Due to a variety of cost-optimization options and techniques, RMC expert GxP quality systems audits can be more cost-effective than audits conducted by internal personnel (see example case study for Cost Effective GMP API and Supply Chain Audits)
  • All RMC audits (inspections) are conducted on behalf of clients according to a written agreement with the client and, if requested, RMC’s approved Quality Manual and written procedures which are modeled to meet the requirements of ISO 17020 First Edition 1998-11-15 General criteria for the operation of various types of bodies performing inspection

Bioanalytical Oversight Services

  • Provide quality and compliance oversight for internal and external bioanalytical testing programs for clinical and non-clinical samples
  • Manage contract service providers in developing and validating bioanalytical methods per current guidelines (e.g., 2001 FDA Guidance to Industry Bioanalytical Method Validation, etc.)

QA Training Presentations and Videos

  • GMP Topic Specific Training
  • Customized QA or QC Training Videos