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Top 10 Compliance Consulting/Service Companies - 2020


As pharmaceutical companies are known to operate in one of the most dynamic business environments, they face the incredibly challenging task of complying with strict rules and regulations across all aspects of their business. Various pharma companies worldwide are altering their compliance practices to conform to regulatory measures for identifying quality issues before they impact production. Since compliance is an integral part of ensuring patient safety, any violation of regulatory methods or non-compliance of standards could tarnish a company’s reputation, which has a detrimental impact on revenue as well.

With rising cyber-attacks and unethical practices, companies are becoming increasingly cautious about regulatory compliance. More and more pharmaceutical organizations are looking at how groundbreaking technologies like RPA and ML in pharma can automate and improve their regulatory compliance activities to deliver better productivity. With a significant reduction in the possibility of human errors, RPA can assist the pharmaceutical industry in meeting stringent standards and complex regulations. Effectual RPA integration can also reduce production and compliance costs, generating a higher ROI for pharma organizations.

Staying abreast of all the latest developments, Pharma Tech Outlook has shortlisted the most promising compliance solution and service providers. A distinguished panel comprising prominent CEOs, CIOs, VCs, analysts, and the editorial board of Pharma Tech Outlook has compiled a list of solution providers and consulting companies at the forefront of deploying advanced pharma compliance solutions to safeguard effective manufacturing of pharmaceutical products.

We present to you- “Top 10 Compliance Consulting/Service Companies—2020”

    Top Compliance Consulting/Service Companies

  • Analytical Lab Group (ALG) provides FDA-regulated and EPA-focused contract testing laboratory services across the U.S. Under an aptly suited tagline — Helping Protect Life® — ALG has amplified its efforts in conjunction with key pharma organizations to take the helm of the ongoing fight against COVID-19 and save lives. ALG is functioning at 100% capacity, providing clients with cutting-edge lab testing services. Today, ALG is one of the few labs in the U.S. conducting tests on the novel SARS-CoV-2 virus. Alongside, the company is testing with the human coronavirus 229E strain and analyzing its reaction to various disinfectant and sanitizers. This technical and scientific expertise, combined with a motivated workforce, is making ALG one of the best-suited companies to augment the laboratory processes amid the COVID-19 pandemic

  • North Carolina-based NuEra Health Alliance—which specializes in marketing promotion and operations for the pharmaceutical, biotech, and medical device industries— can lower operating costs without sacrificing compliance or risk and find they have the ability to respond to competitive and governmental requests quickly, if and when needed. A boutique consulting firm, NuEra, can help organizations build more flexible and proactive processes and teams that work together better and can more quickly scale up or scale down depending on the circumstances. The organization has a proven track record of helping life sciences companies drive efficiency and reduce the workload on staff that is often overwhelmed with large volumes of material

  • With over 27 years of experience, PharmaBioServ provides world-class global consulting services to the Life Sciences Industry. As a life sciences industry leader in regulatory compliance, validation, advanced therapy products, and other regulated industry support services, PharmaBioServ understands that to start the manufacturing of drugs in any place is not a short, simple process. The company’s services are in accordance with the latest FDA, EMA, ANVISA, and other international agency regulations and guidelines. All PharmaBioServ’s services are founded on a philosophy of excellence through its personalized, hands-on experience and trained resources

  • Pinnaql is helping the pharma and life science industry meet their compliance needs through expert consulting services

  • APCER Life Sciences

    APCER Life Sciences

    APCER Life Sciences provides comprehensive drug safety/pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally. We bring medicinal / scientific expertise through our healthcare professionals & physicians and address full pharmacovigilance requirements for North America, UK & Europe markets. Our clients benefit from our vast experience in regulatory submissions across 100+ countries and consultative approach towards audit /inspection readiness

  • Chamow & Associates

    Chamow & Associates

    Chamow & Associates is a leading provider of consulting services to the biopharmaceutical industry. Established by Dr. Steven Chamow in 2008, Chamow & Associates provides expert advice and guidance on the phases – preclinical to commercial – and costs of biopharmaceutical product development. Our expert team focuses exclusively on CMC—chemistry, manufacturing and controls —and specifically on biotherapeutics, with a focus on monoclonal antibodies. Our services include the key areas of CMC: technical design for production of drug substance and drug product, formulation and delivery of drug product, quality control and quality assurance, regulatory compliance and filing, and coordination of CMC activities between ourselves, clients and vendors

  • Freyr


    Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions. Freyr is a trusted partner, providing end-to-end Regulatory services across 8 of the Forbes* Global Top 10 Healthcare / Life Sciences, Mid-market $1+ Billion Bio Pharma, and Several Small-Medium, Fast Growing Life Sciences companies, CROs and Standards agencies

  • IPS-Integrated Project Services

    IPS-Integrated Project Services

    IPS-Integrated Project Services, LLC is a global leader in developing innovative solutions for the consulting, architecture, engineering, project controls, construction management, and CQV of technically complex facilities worldwide. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations

  • Labtopia


    Labtopia is a technical services company providing staffing, consulting, training and informatics. Labtopia Staffing is a full-service staffing firm providing flexible solutions to manage your scientific, technical & managerial staffing needs. Labtoptia Informatix experts aid laboratories with design, selection, implementation and support of software for effective lab operations. Labtopia Solutions provides our clients tailored quality system advisory services to help businesses meet regulatory requirements and enhance performance. Labtopia Training offers our clients fully customizable technical and soft skills curricula proven to both improve and empower staff

  • Vigilare


    Vigilare International is a full service safety services organization providing pharmaceutical, biotechnology, and medical device companies with a full range of product safety services. Vigilare International has 45 years of combined leadership experience; this assures clients that projects are managed effectively and efficiently. Angela Pitwood, Vice President, provides oversight for all programs. Angela has overseen processing for hundreds of thousands of events for hundreds of drugs. Her prior strategic experience in development and oversight of large pharmacovigilance programs is a strong assurance that all client projects are developed and managed to the highest level of industry standards