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Regulatory Affairs Consulting


The Use of Regulatory Affairs Consulting Firms is on the Rise

Spending on regulatory outsourcing is increasing. A recent survey reports that 68 percent of pharmaceutical companies use regulatory affairs consulting firms to perform 10 to 20 percent of their regulatory affairs tasks. In 2010, only five percent of regulatory affairs functions were outsourced. Regulatory compliance is vital to company earnings and growth, but regulatory maintenance is time-consuming; it can divert staff from concentrating on other important strategies like reimbursement and R&D. The use of validation consultants is also growing rapidly.

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Drivers behind the Growth of Regulatory Affairs Consulting and Validation Consultants

Outsourcing to regulatory affairs consulting companies and validation consultants has become more prevalent for many reasons. The most obvious reason is time. In today's ever-changing health care landscape, life science companies are struggling to do more with less. Submitting regulatory documentation that is accurate and meets submission criteria is a laborious job. Even routine lifecycle maintenance activities, such as label changes and renewals, require significant time and effort. Enlisting the services of a regulatory affairs consulting firm allows regulated companies to focus on their core competencies and strategies rather than tactical activities like document management.

Validation is another important driver. Virtually everything that touches the quality system, from the analytical methods used to ensure quality control to the software systems companies rely on to accelerate compliance, must be validated by a validation consultant. Validation is not only a regulatory necessity but also a useful tool for assessing and maximizing the value of your design and business processes.

Validation of a pharmaceutical manufacturing process is an essential in order to comply with good manufacturing practices (GMP) contained within the Code of Federal Regulations (21 CFR) established by the FDA. Validation consultants, who are often employed by regulatory affairs consulting companies, can help a regulated company establish its validation master plan and other important validation-related tools.

One final driver is globalization. As more companies look to emerging markets to increase their profits and growth, there is an increased need for a broader level of local, ground-level expertise, which a global regulatory affairs consulting company can provide.

Regulatory Affairs Consulting Companies and Validation Consultants: What They Do

A validation consultant or regulatory affairs consulting expert performs many critical tasks. For example, he or she can help a regulated company:

  • Create and Implement a Validation Master Plan (VMP)
    Inadequate validation is a leading cause of FDA 483 warnings. Many companies struggle with validation because they view it as a one-time project, rather than an ongoing process; others find it difficult to distinguish what needs to be validated from what doesn't. A validation consultant can help you constructing a validation master plan (VMP) that drives you to make these critical decisions. A good VMP can even help you detect and resolve problems in advance.

    A VMP outlines the areas and systems to be validated based on risk and provides a written and standardized plan for achieving continuous compliance. Regulatory affairs consulting experts know it is often the first document inspectors ask to see during an audit. A comprehensive VMP assures regulators that the systems and processes you have in place will continue to meet the requirements of 21 CFR 820.75; a poorly written or nonexistent VMP invites further regulatory scrutiny.

  • Perform Process Validation
    The purpose of process validation is to ensure that varied inputs lead to consistent, high-quality outputs. It consists of three stages: process design, process qualification and continued process validation. When done correctly, by an experienced validation consultant, process validation significantly reduces rework, operating costs and even potential recalls.

  • Improve Submission Timelines
    In today's competitive global marketplace, success boils down to data submission and regulatory approval. Regulatory affairs consulting firms teach companies to identify and resolve hurdles in their current regulatory process so that they can get their products to market faster.

  • Perform Product Design Validation
    Many companies incorrectly assume design validation is user testing—or confuse it with design verification. Understanding the difference is key to compliance success. Successful product design requires the orchestration of multiple complex systems and processes, including design control, compliance management, risk analysis/assessment and design and process validation. Few companies have the time or expertise to address all of these areas, so they outsource to a validation consultant.

  • Improve Efficiency and Productivity
    In this era of health care reform, many life science companies are balancing heavier workloads and struggling product pipelines. The margin for error, particularly when it comes to submissions, is extremely narrow. Efficiency and productivity are preponderant. Regulatory affairs consulting firms can help an overwhelmed in-house regulatory affairs team, improving the company's overall efficiency and productivity.

  • Perform Software Validation
    Any software that touches the quality process must be validated to meet "3Q" criteria: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The process of identifying, creating and executing the 3Qs can be the most problematic and time-consuming aspect of software validation, and can significantly delay the transition from a paper-based to an electronic QMS. Hiring a validation consultant to handle the 3Qs is a real time saver.

  • Manage the Impact of Globalization
    Regulatory policies are undergoing a massive harmonization effort, but the process is taking longer than expected. In the meantime, companies are struggling to stay on top of a myriad of ever-changing rules and regulations from a growing array of regulatory bodies. Regulatory affairs consulting firms teach companies how to implement processes and best practices that make it easier to stay current. Also, they advise companies that are hoping to expand into international and emerging markets about local regulations and guidelines.

  • Perform Equipment Validation
    Formulating an equipment validation protocol is a daunting task, which is why it is often outsourced to an external validation consultant. There are many elements to qualify, including documentation, equipment/component design, instrument calibration, utility supply, environmental regulations, safety codes, SOPs, and instrumentation. An efficient equipment validation protocol will accelerate the launch of a new product; it should include Test Method Validation (TMV) and Operational Method Validation (OMV).

MasterControl QCC Regulatory Affairs Consulting /Validation Services Help You Stay Compliant

Maintaining compliance, particularly when it comes to submissions and validation, is both challenging and tedious. Forming an alliance with an experienced, well-respected team of validation consultants and/or regulatory affairs consulting experts can save you time and effort and give you a competitive edge.

QCC experts will analyze your existing systems based on risk, and then help you create a comprehensive VMP, encompassing all of the systems and processes that require validation. They will also help you develop the testing protocols and SOPs and improve the quality and value of your system as required by the FDA and international GMP regulations. You will enjoy the business and operational benefits of compliance without the added stress and disruptions.

QCC is comprised of a highly experienced international team of QMS experts, regulatory affairs consulting professionals, auditors, certifiers, process engineers, validation consultants, and educators who not only know the life sciences and manufacturing industries inside and out but also understand your business and the unique demands of regulated companies like yours. Our experts provide guidance in seven core regulatory, compliance, and quality disciplines:

  • Quality Management Systems
  • Regulatory Acceptance/Compliance
  • Quality Process Training
  • Supply Chain Management
  • Validation Services
  • Certification/Accreditation Assistance
  • New Product Acceptance

For More Information on MasterControl's Regulatory Affairs Consulting Services

If you want to outsource some of your regulatory affairs tasks or need design, equipment or process validation assistance, contact us today at +1 (866) 747-8767.