QA Outsourcing

In today’s competitive business environment, life-science companies run lean, particularly in terms of personnel. The quality assurance (QA) function creates complexity for pharmaceutical companies because need and cost vary depending on both the quality & regulatory lifecycle.

Regulatory Affairs

An early-stage pharmaceutical manufacturer needs strategic regulatory affairs (RA) leadership as the new drug is registered and filed with regulatory agencies. Once the RA strategy and filings are in place, the company’s regulatory needs often transition. Priorities become ensuring the product is kept up-to-date with the regulatory expectations, new requirements, and changes in the manufacturing process. The quality function typically sees a similar pattern of heavy strategic needs followed by maintenance needs.

regulatory compliance

For a small- or mid-market company, this shift can create challenges for appropriate in-house staffing, particularly if the company has one or a limited number of products. It can mean an expensive hire early in the company’s lifecycle, followed by a period when the executive is too much horsepower for the maintenance needs of the company.

Quality Assurance

Outsourcing quality assurance can provide a better match to changing strategic needs through the company lifecycle. These are common options to consider:
  • Sole practitioner
  • Enterprise consulting firm
  • Dedicated QA consulting firm


Sole Practitioner Consultant


With corporate downsizing, many executives with quality and regulatory expertise are establishing small consulting practices. With their long and accomplished resumes, they easily attract pharmaceutical clients. Sometimes, the clients are former employers and colleagues, who value their expertise but can’t afford to have on the full-time payroll.
This arrangement enables the pharmaceutical company to hire RA/QA staffers as needed, while using the outsourced QA/RA executive on an as-needed basis for large strategy projects.

Subject Matter Expert


Problems can arise with this model when the pharmaceutical company changes scope or scale beyond the consultant’s capabilities. Additionally, when the sole practitioner finds a full-time job and decides a steady paycheck with benefits is better than pharmaceutical consulting.
So, while using the sole practitioner model, the pharmaceutical company may be best served by maintaining a rolodex of multiple subject-matter experts.

Enterprise Consulting Firm


Enterprise consulting firms offer services in more than one functional area, typically operations and financial areas. These firms can be ideal for early- and mid-market pharmaceutical companies because they represent one-stop shopping in multiple areas. Often these firms are large and can attract talent, which the life science company can access as needed.
Problems can arise with this model when the consulting firm lacks a deep stable of RA and QA talent, but rather brings in executives as needed. This arrangement can mean delays in getting help and also can mean a higher price tag when the firm adds a markup.
Therefore, the pharmaceutical company may be best served by validating the talent they receive, and by communicating their QA/RA needs well in advance to their enterprise consultants.

Quality Assurance & Regulatory Affairs Consulting Firm


The focused Quality Assurance & Regulatory Affairs consulting firm is a blended solution. Because quality and regulation is their only business, these firms generally provide good talent at a fair price. They can offer a variety of QA consultant or RA consultant options and should be able to scale or change direction quickly.
Problems can arise in identifying and vetting the QA RA firm because there are few large players with a national reputation. The pharmaceutical company may be best served by establishing a due diligence process that matches their needs to the consulting firm’s strengths.
The following cases illustrate several approaches that provide QA RA expertise while saving money.

Outsourced QA RA Insights

One established pharmaceutical company evaluated its product lifecycle and decided to implement a series of changes surrounding the API. Retiring the old API, transitioning to the new API, and the related activities were simply beyond the bandwidth of the quality and regulatory team in place.
The pharmaceutical company recognized there would be economies of scale by using the same team of outside experts over the course of multiple projects. Additionally, the pharmaceutical company found that having local experts also saved on travel costs. This allowed the consulting firm to become part of the team, adding value to ad hoc meetings and integrating into their quality and regulatory functions without being on the payroll.

New Product Development

A Fortune-500 company was planning a new drug/device product development using disruptive technology. Recognizing that risk management and speed-to-market would be crucial for early adoption and success, the company decided to create a new subsidiary to develop and launch the product.
The seasoned QA and RA management stay with the Fortune 500 enterprise instead of joining the subsidiary, whereas some of the early- and mid-careerists were attracted to the startup venture. The subsidiary realized they had staff to implement but lacked QA RA leadership and deep expertise.

Quality Management System

The QA RA consulting firm was brought in to complete product development, direct regulatory filings and compliance activities, and to set up a quality-management system (QMS). The subsidiary had originally planned to adopt the QMS of the parent company but the consulting firm pointed out the need to right-size the legacy QMS for the new start-up subsidiary.
With ongoing outsourced QA RA expertise and their implementation staff, the subsidiary was able to launch the product, comply with all regulations, and implement their QMS systems without hiring expensive executives. Additionally, some of their staff used the consulting firm as their mentors and used this opportunity to step up. Over time, there were some internal promotions within the QA/RA team because the subsidiary had created a culture of promoting from within.

Benefits For Early-Stage Companies


Example one

A biotech startup was in a Phase II clinical trial and struggling with its cash-burn rate. They had a four-person quality team in place in anticipation of future needs.
Their QA/RA consulting firm recommended managing work more efficiently, scaling back to two analyst-level personnel and augmenting with occasional consultation by outsourced quality experts. This model was possible because the quality systems were already in place but didn’t need such heavy staffing.
By transferring expenses away from the quality function, they were able to deploy additional resources to the scientific and product development area, their greatest need.

Example two

Another early-stage company engaged a consulting firm because the owners were not familiar with the regulations surrounding their medical device. The team had a business plan in place, a solid IP platform, and a distribution plan, but the company lacked a regulatory pathway.
A consulting firm provided the company with an overview of the RA and QA requirements. Because the leadership team was bootstrapping the company, they decided to purchase off-the-shelf quality documents and asked the consultants to fill the gaps.
The consulting firm began a steady process of backfilling where the firm needed help, such as matching the purchased standard operating procedures with the business needs and remediating the product development in accordance with the developing QMS. As the launch date for the new product approached, the consulting firm helped the company implement corrective and preventive actions and a complaint system, along with an internal audit plan.
The consulting firm performed all this QA RA oversight and backfilled the firm’s gaps while working within a fixed monthly fee, helping the firm’s cash flow requirements. The product has since launched and is a commercial success.
As the company continues to grow and scale, the consulting firm continues to provide ongoing support as the outsourced QA RA manager, working hand-in-hand to augment the firm’s capabilities, while keeping their expenses to a manageable level.


Outsourcing quality and regulatory expertise can bring needed experience while saving costs. As companies grow and scale, they need flexible models for meeting their evolving compliance needs, and outsourcing can provide value.


regulatory compliance


Complete article published in BioPharm International.


About RCA’s Pharmaceutical Consulting Services 


Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.


Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 


Client Solutions


Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:


  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans


Regulatory Affairs


Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.


As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.


  • New Product Support
  • Product Lifecycle
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  • Combination Products


Compliance Assurance


The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.


  • Assessments
  • Audits
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  • Preparation and Training
  • Inspection Readiness
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Quality Assurance


Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.


  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics


Remediation Services 


Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.


Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.


  • Regulatory Action
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About Regulatory Compliance Associates


pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.


Commitment to Quality


Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.


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