Quality and Compliance

We bring a systems approach to Quality operations, viewing Quality as a technical platform designed to eliminate mistakes and improve product quality, rather than just a reactive policing program in place to detect wrong-doing.

We typically operate in teams, providing you with cross-functional CMC expertise for GMP projects, as well as GLP and GCP Quality Systems (Quality Assurance) expertise. We have experience with products from development through commercial stages and are knowledgeable with US, Canadian, European and various Asian GxP regulatio

GxP Quality Systems and Management

  • Outsource senior quality systems leadership – we can serve as your Quality Unit Management (Learn more about outsourcing QA with RMC)
  • Development of customized Corporate Quality Systems Master Plans
  • Quality consultation, strategy development and gap analyses
  • Integration of quality and technology
  • Compliance enhancement programs
  • CAPA system development and/or tracking execution
  • Supplier Quality Agreement negotiation on behalf of clients
  • Quality project management of GxP contract service providers

GxP Quality Assurance and Quality Control

  • Outsource Quality Assurance – we can serve as your functional QA team (Learn more about outsourcing QA with RMC)
  • Planning and execution of Quality Assurance/Quality Control review projects
  • 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 GxP manufacturers and laboratories
  • Development, evaluation and/or execution of stability programs
  • Validation services for GxP 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
  • velopment, evaluation and/or execution of stability programs
  • Validation services for GxP methods and equipment

Outsourcing Quality Assurance with RMC

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

  • Drug API and product manufacturing, control and release sponsor responsibilities
  • 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 (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?

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

Why consider QA outsourcing?

  • The ultimate approach to ensure independent quality oversight
  • Immediate access to experienced experts, with 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
  • 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/distribution/logistics 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
  • 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 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.)

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.)