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Life Sciences Compliance

Connecting Your Business to the Resources That You Need

Charter Global offers Regulatory Compliance consulting services, all designed to help your company be compliant with the FDA. Whether you’re looking for a small tweak or complete overhaul, we have you covered. Our services are flexible so you can get precisely what you need.

Charter Global delivers quality, compliance and regulatory services with a focus on FDA regulations relating to pharmaceutical, medical device, biotech, and nutraceutical. We develop comprehensive regulatory solutions for the life sciences industries. With our proven knowledge and experience to identify risks and gaps, we can implement solutions that achieve compliance and enhanced business operations. The Charter Global team strives to deliver quality beyond compliance. Whether it is the writing of a simple SOP, responding to a 483, moving your product globally or staffing and managing global projects, Charter Global leverages our expertise in regulatory compliance to offer comprehensive solutions. Simplifying Regulatory Compliance!

We recognize that each company is unique. One-size-fits-all approaches will never help your business reach its full potential. We deliver custom solutions, tailored to you – your industry, your culture, and your one-of-a-kind challenges.

  • Expert Analysis – Identifying your critical and non-critical deficiencies
  • Strategic Planning – Crafting a plan to take you there
  • Risk Management – Minimizing your compliance risks

REGULATORY COMPLIANCE AND AFFAIRS

The challenges facing today’s biopharmaceutical and medical device companies are greater than ever. For companies to take promising therapies from the laboratory to the market, they must protect those therapies from regulatory and reputational risks. Keeping up with all the new policies added every year by governing bodies like the FDA, ICH, or EU can be overwhelming. It’s common to feel like you’re drowning, struggling to keep up with the latest regulations. You may worry about the fines, penalties, and even severe legal actions that one small infraction could impose. We understand your concerns.

With Charter Global as your trusted partner, our consultants will integrate seamlessly into your organization and deliver effective services while reducing compliance cost. Our services range from writing SOP’s to staffing and managing long term global projects. We want to reduce your stress and simplify your job.

  • IT Compliance
  • Global Compliance
  • Audits
  • Assessments
  • Remediation
  • Computer System Validation (CSV)
  • Compliance Training

QCSS SOLUTIONS FOR LIFE SCIENCES

Quality and Compliance Shared Services (QCSS) has the flexibility that allows you to have FDA compliance within your budget. With the QCSS solution you have the flexibility to select the level of support of a Quality / Compliance / Regulatory Manager. Do you need just 10%, 50%, 75% or more of a resource? With QCSS we can deliver exactly to your resource needs.

VENDOR MANAGEMENT

The risks posed by third party relationships (vendors, suppliers, agents, distributors, resellers, etc.) are huge – and often unaddressed. Regulations continue to increase as businesses become more global, and more and more companies are looking to address these risks.

Charter Global vendor management solutions help clients to control costs, drive service excellence and mitigate risks to gain increased value from their vendors throughout the deal life cycle.

Let your “vendor headache” become our team’s challenge.

LEARNING SERVICES

Infinite positive rewards are created by improving your teaching and learning experience. Charter Global professionals are committed to making the experience engaging, collaborative, and more effective for everyone through our improved learning methodology.

Organizations across the globe share the same goals and face similar challenges as you do every day. Whether it’s improving learning outcomes, increasing engagement and collaboration, achieving greater efficiency, or expanding learning opportunities, the Charter Global team has helped organizations just like yours meet their demands and achieve their goals faster and easier than ever before.

Services Provided:

  • eLearning
  • Course Development
  • Instructional Design
  • Live Course Delivery

SKILLS GUARANTEED

All of our employees are suitably trained and qualified, with many years of professional experience. Many of them have already worked as consultants in various countries – a key factor for success given the global nature of the life science industry. Our employees undergo continual development to ensure that our services and solutions comply with recognized quality standards. We apply the latest, most effective methods to meet your requirements and to ensure that your experience as one of our partner clients is both positive and rewarding.

Benefits:

  • Range of experience with multiple FDA areas of expertise
  • Dedication to create programs that ensure self-sufficiency
  • History of meeting and exceeding client expectations

Let us help Simplify your Compliance!

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