Top 10 Pharmaceutical Compliance Consulting/Services Companies - 2019
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Top 10 Pharmaceutical Compliance Consulting/Services Companies - 2019

The pharmaceutical industry is experiencing a period of heightened regulatory scrutiny globally. This scrutiny is occurring in several areas, including sales and marketing practices, government drug price reporting, the privacy of a patient, customer health information, clinical operations, post-marketing drug safety reporting, and in quality control activities around manufacturing operations. Moreover, the greatest dilemma that most pharmaceutical organizations are facing is the complex balancing act of driving business innovation and achieving goals while simultaneously mitigating compliance risk.

This need to balance is driving a powerful reaction among them to form an alliance with an experienced regulatory compliance provider to help them identify root causes, develop corrective and preventive action plans, and mitigate associated risks quickly and effectively-without taxing the company's internal resources. Being the cynosure of public and federal agencies, pharmaceutical companies need to make sure that they have defined and robust compliance practices in place. Identifying, analyzing, and mitigating compliance risks are essential in developing an effective compliance program and ensuring the future sustainability of the industry.

In fact, digital technologies can make it possible for compliance providers help pharmaceutical companies to move away from mechanical tasks, keep up with the growing amounts of data, and transform compliance into a value-creating organization that anticipates what can go wrong and prevent it from happening. Notably, the adoption of digital technologies such as machine learning, AI, Big Data, RPA, and NLP can help compliance maintain its position as a strategic partner to the business.

Besides, holistic compliance services untangle intricacies in patent, product, and supplier management functions and enable pharmaceutical companies to pass stringent tests of regulatory bodies. These services also help companies embrace new-age technologies like cloud, big data, and analytics while proactively mitigating risks. It allows companies to manage their processes easily and subsequently enhance their workflows. Hence, the pharmaceutical industry is diligently identifying areas across the regulatory value chain that can potentially be centralized and harmonized to achieve compliance faster using cost-effective methodologies.

Understanding the changing times, Pharma Tech Outlook has compiled a list of Top 10 Compliance Service Providers to guide companies associated with the pharmaceutical sector in harnessing the power of technology to leverage digital capabilities in compliance and address myriad of regulatory requirements, reduce risks, and increase efficiencies, while simultaneously broaden treatment options and help improve patient health.

In this edition, we are glad to feature APCER Life Sciences, Freyr Solutions, Integrated Project Services (IPS) and Proclinical Consulting who work together with their clients on the strategic planning of regulatory needs by providing tailored end-to-end quality, compliance and regulatory solutions and services to achieve a successful outcome.

With several innovative technological capabilities and success stories up its sleeves, these Organizations are constantly proving its mettle in the field of compliance for pharmaceutical companies. We hope this issue of the Pharma Tech Outlook helps you build the partnership your firm needs to address their compliance needs better within the silos of individual operations or business functions.

We present to you Pharma Tech Outlook' "Top 10 Compliance Service Providers - 2019."

Top Pharmaceutical Compliance Consulting/Services Companies

APCER Life Sciences; the services and consulting firm, is committed to helping pharma organizations (pharmaceutical, biologics, vaccines, devices, OTC and consumer healthcare product lines) to deliver compliant products that meet the industry’s regulatory requirements. To meet the growing requirement of robust pharmacovigilance services, APCER has streamlined and well-documented processes in place that they have broadly characterized in few areas. Additionally, APCER has requisite technology platforms (industry-leading MedInfo system) to process the information; while they also work on clients' systems to integrate with their processes for the effective resolution of queries

www.apcerls.com

Compliance & risk drives business advantages for customers by providing superior regulatory intelligence, feedback and activities through C2P, the software platform for knowledge management, consultancy, market access, managed services and other solutions. The business is known in the engineering, consumer products and distribution, industrial goods and life sciences industries as the end to end international regulatory services supplier. Founded in 2002, Irish-owned Compliance & Risks assists manufacturers, retailers and their logistics partners in monitoring and managing specifications, standards and regulations for a smoother, stronger and better world

www.complianceandrisks.com

Freyr is a leading niche, full-service global regulatory solutions and services company established in 2007. The company offers full-spectrum, end-to-end regulatory services that span across strategy to submissions and lifecycle maintenance. Freyr is ISO 9001 and ISO 27001 certified. It enables large, medium and small size global Life Sciences organizations to meet their regulatory goals around the world. With a global presence across over 120 countries, Freyr has specialized Centers of Excellence (CoEs) focusing on the entire regulatory value-chain. The CoEs comprise those for regulatory affairs, compliance, audit and validation, regulatory strategy, regulatory intelligence, regulatory labeling, regulatory medical writing, publishing & submissions, and artwork pack management

www.freyrsolutions.com

Among the 10 Compliance Solution Providers, IPS-Integrated Project Services (IPS) serves as an enabler of Pharmaceutical Manufacturing and Compliance. The company develops innovative business solutions for the biotechnology and pharmaceutical industries through operational expertise and industry-leading knowledge. As a full-service consulting firm, IPS hones capabilities across technical consulting, architecture, engineering, construction management, commissioning, qualification, validation, QMS development, and overall operational readiness support. It assists with the product manufacturing life cycle for biopharmaceutical organizations as they traverse through multiple stages of compliance and regulatory processes

ipsdb.com

Headquartered in Washington, DC, Guidehouse has more than 1,800 professionals in over twenty locations. It is a Veritas Capital portfolio company and is led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets and agenda-setting issues driving national and global economies. Guidehouse is providing one of the best of management, technology, and risk consulting services to the public and commercial sectors. They help clients solve their toughest challenges through the co-creation of scalable, innovative solutions to prepare for future growth and success. The company serve healthcare, energy, environment, aerospace & defense and many more sectors

guidehouse.com

Headquartered in London, Proclinical Consulting is a privately held company that fuels the growth of the global life sciences industry. The company supports biopharmaceutical and medtech companies throughout the product development lifecycle, providing advisory and operational expertise to develop, register, and launch products through the provision of strategic scientific and commercial advice by engaging with payers and regulators globally. Proclinical Consulting forms long-term partnerships with individuals, teams, and whole organizations, helping them thrive and do great things in the industry. By blending deep industry expertise with a flexible approach, Proclinical Consulting functions as an extension of clients’ teams to achieve successful outcomes

www.proclinical.com

ASI DATAMYTE

ASI DATAMYTE

For more than four decades, the main emphasis of ASI DATAMYTE (ASI) has been the design and international delivery of quality management systems related to hardware and software. This focus has provided them with the experience and knowledge to create a complete place in the manufacturing sector. ASI is the international standard for creative solutions to quality assurance. The ability of ASI to implement solutions globally is a key reason why customers continue to partner with us. Anything they do takes into consideration cross-plant usability and regional deployment throughout the whole lifecycle of the brand

ProPharma Group

ProPharma Group

To overcome their diverse problems, ProPharma Group works with life science firms. As an element of the user's team, they are concerned not only with the quality of a company's products through the lifecycle of production but also with the security of items and the patients using them. The team at ProPharma has a wide range of experience to broaden the capability and resources of clients and pulls on their vast knowledge base to customize custom solutions relevant to specific project requirements

TrialScope

TrialScope

TrialScope simplifies the importance of openness in clinical trials. Their validated approaches have been effectively and thoroughly evaluated in the most extreme environments and are overseeing reports for partners who are responsible for more than 35% of clinical trials reported on clinicaltrials.gov funded by the industry. The business-driven alternatives and skills of the company facilitate advertisers to enhance performance, minimize compliance hazards, and eventually optimize efficiencies with life-cycle management tools, expertise, and processes for clinical content. TrialScope technologies are offered in a private cloud via a validation-ready SaaS platform

Trinity Consultants

Trinity Consultants

Trinity designs and executes strategic strategies that meet the ecological and related business goals of clients effectively, while at the same time supporting their staff and investors. Trinity will be one of the leading suppliers of intelligent ecological and market technologies. By providing unprecedented value to consumers, they can maximize customer satisfaction. Long-term consumer agreements will be vital to reaching your business goals. The core values of Trinity embody quality assurance, competence, and consistency. That idea guides their corporate decision-making and guarantees consistently high-caliber assistance is provided to their customers