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Regulatory affairs

This Regulatory affairs section features Regulatory affairs companies, inc pharmacovigilance.

Hanover Communications

Healthcare is evolving rapidly. To stand out from the crowd requires a potent combination of rich insight, innovative ideas and flawless execution. We are an uncommon health communications agency with a deep understanding of today’s complex healthcare environment.

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Havas Life Medicom

We are a fully integrated agency that is 100% dedicated to creating standout communications in healthcare. Our success starts by strategically aligning promotion, medical education and PR across the product lifecycle, using creativity and innovation to craft persuasive stories. Our experts in strategic consultancy, cause and corporate campaigning, work with our clients to put their story at the centre of the healthcare agenda and help people around the world own their healthcare conversations.

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McCann Health Medical Communications

We are the medical communications experts within McCann Health. Communicating science to bring meaning and positive change to people’s lives.

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Sciterion

Sciterion is an award winning specialist healthcare communications consultancy within the Havas Health network of companies. We exist to make a positive contribution to patient care. Real world experience of patients is at the heart of our programmes; Sciterion are experts at rigorous insight generation and multi-stakeholder co-creation. Through a deep understanding of health behaviour, we align key stakeholder touchpoints to deliver intelligent, highly impactful and clinically relevant programmes. Our industry- leading standards of medical and scientific excellence, coupled with robust behavioural knowledge, advances clinical practice and optimises real world patient outcomes.

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Syneos Health®

Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Learn more about how we are Shortening the distance from lab to life® at syneoshealth.com.

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CACTUS

Founded in 2002, Cactus Communications is a fully integrated, global scholarly communications company with offices in Japan, South Korea, India, China, the United States, and Singapore. Employing a global workforce of over 500 and a strong global network of medical writing experts in pharmaceuticals sciences, CACTUS helps pharmaceutical and medical device companies in the successful dissemination of technically rigorous and compliant scientific documents. CACTUS believes in helping its customers scale the farthest reach of their vision by equipping them with therapeutic expertise and integrated software to translate scientific evidence into commercial success. Please visit www.cactusglobal.com for more details.

Clinigen

Clinigen Global Access Programs specializes in the consultancy, development, management and implementation of access programs across the product lifecycle for biotechnology and pharmaceutical companies.

Complete Regulatory

Complete Regulatory is a specialist medical writing group

Compliance Hub Ltd

The most trusted and established compliance agency providing creative solutions for pharmaceutical and healthcare industries. Specialists in ABPI, ABHI and EFPIA codes of practice - provides training, audit and consultancy services.

Consumation Ltd

Consumation produce highly usable documents, instructions, leaflets and forms. There’s more to a great leaflet than meets the eye. Our experts know the trade secrets of layout, typography and plain language and avoiding jargon – and they’re well versed in the research evidence on patients’ information preferences. Our in-house designers specialise in world-class information layout and typography. Trust them to find an innovative solution! You’ll be surprised at the range of stuff we’ve done: consent sheets, educational and professional materials, research papers, forms and newsletters. Oh, and we’ve worked on a few hundred other instruction leaflets.

DDI LLC

DDi is a prominent Technology partner to the Life Sciences industry. DDi has built its solution competency with a unique blend of functional and domain expertise to serve the technology needs of global clients.

Decideum

Decideum has over 20 years experience in providing nuanced, effective and results-driven HTA and market access support to pharmaceutical clients in the UK and EU.

Freyr Solutions

Freyr is a Global Regulatory Solutions and Services company, focusing on the entire Regulatory value-chain ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions to post approval maintenance, Labeling, Artwork Change Management for Pharmaceutical, Generics, Medical Device, biotechnology, Biosimilar, Consumer Healthcare, Cosmetic companies across the globe.

Global ConSeptS - Consultancy

Global ConSeptS - Consultancy is an independent technical consultancy company that was established in 2008. The company specialises in aseptic processing and Quality by Design projects  specific to the global bio-pharmaceutical industry. Our approach is pragmatic and to-the-point. You are our customer and we want you to get the best technical solution rather than a theoretical proposal. Although today Global ConSeptS is a one-man company, we want you to be best served. That is why we closely work together with other competent consultancy companies to provide you the best quality for your projects and assure you on-time delivery.

Highbridge Pharma

We are a key player in the regulatory/NPD services sector consisting of well-seasoned professionals with in-depth exposure to practically all aspects of medicinal product development with a primary focus on activities in Europe, North America and Asia Pacific.

LCGC TRUCAL AND SERVICES LLP ( MASS CALIBRATION LABORATORY)

LCGC TRUCAL IS A MASS CALIBRATION LAB, BASED OUT OF INDIA, AN ISO/IEC/17025 ACCREDITED LABORATORY. ISO 9001:2008 CERTIFIED. SUPPLIES NEW WEIGHT BOXES, RECALIBRATES THE EXISTING WEIGHTS. E2,F1,F2, M1. CLASSES

MD Events

MD Events are experts in the planning and delivery of meetings and events worldwide. We have a wealth of experience in highly-regulated industries, such as pharmaceutical and healthcare, financial services, banking and insurance. This, combined with our professional, enthusiastic and dedicated team, keeps our clients returning time and again.

Pharma Design Limited

Strategic and Regulatory advice Market Access and Price Analyses Clinical trials planning Pharmacovigilance Regulatory support during clinical development & Risk Management Ongoing liaison with regulatory authorities throughout Europe Interim medical directors Establishment of European subsidiaries, headquarters, management teams

Pharmaceutical Development Services Ltd

Pharmaceutical Development Services Limited (PDS) is a pharmaceutical and regulatory consultancy serving the pharmaceutical, biopharmaceutical, medical device and cosmetic industries. The role of PDS is to tell you the current standards for your development regulatory submissions, and what you need to do to meet them. We explain why you need to do what needs to be done, and help you to generate data which will successfully meet the requirements.

PharmaLex - Confidence beyond Compliance

PharmaLex is one of the largest global specialized providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology & Risk Management worldwide.

Pure Drug Safety Limited

We are a leading global pharmacovigilance provider offering detailed responsive solutions through strategic thinking to help 'Pharma make sense of Drug Safety'.

Spectrum Regulatory Solutions

We’ve built our reputation for quality, reliable and responsive EU regulatory affairs consulting with major healthcare companies worldwide. We serve the following industry segments: pharmaceutical, biologics, medical devices, drug device combinations, nutraceuticals, functional foods and veterinary. The results speak for themselves: at least 70% of our business comes from repeat client work and referrals.

TRAC Services Limited

TRAC Services are a regulatory affairs consultancy who help pharmaceutical companies meet the regulatory requirements needed to market and sell their products within Europe.

vector pharma

vector pharma specialises in the provision of close strategic regulatory support to innovative small to medium-size development-phase pharma companies seeking product approval within the EU. vector pharma works very closely with clients on a limited number of projects. Before taking on a contract we will discuss your requirements in detail. If we consider that a project is not appropriate for our resources or expertise we will tell you so.

Weinberg Group

The Weinberg Group is the global leader in regulatory and compliance services. We have provided biotech, medical device and pharmaceutical consulting services for over 30 years.

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