Customized Assessment
Regulatory compliance is crucial for market access, but requirements vary by jurisdiction; developing a strategy ensures access and prepares you for regulatory changes.
Market Access & Regulatory Strategy Support
Manage your Regulatory Changes with Confidence with our Customized Market Access Solutions
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Regulatory
ExpertiseNavigate the diverse chemical control regulations across different jurisdictions with our strategic approach to maximize ROI on compliance efforts.
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Tailored
SolutionsLeverage our global compliance expertise to receive strategic advice tailored to your specific markets.
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Comprehensive
SupportAssess your market access strategy and create a sustainable regulatory approach for your product portfolio.
Understanding Market Access Requirements
Master the complexities of market access to ensure compliance for your product portfolio.
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Market Access Overview
- Market access is the authorization to sell a product or service in a specific market or jurisdiction, influenced by both trade laws and regulatory requirements.
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Scope
- Developing a regulatory compliance strategy involves asking key questions about target markets, product use, technical specifications, sales volume, necessary documentation, and understanding overlapping global requirements.
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Proper Documentation
- It is critical to ensure that you have proper documentation such as Safety Data Sheets, conformity letters, compliance certifications, product labeling, and registrations in place to maintain access.
Our Tailored Market Access Solutions
Personalized Guidance
We assist in evaluating substances and products, preparing for manufacturing or sales in new markets, and handling regulatory submissions and documentation.
Continual Support
We compare requirements across jurisdictions, identify efficiencies in compliance efforts, and continuously monitor global chemical control and emerging regulations to maintain market access.
Meet Our Market Access Experts
Dedicated professionals guiding your compliance journey.
Claire Mathis |MPH, CPPS|
Service Manager: Product Stewardship & Compliance
Springfield, VA, USA
Jenna O’Flaherty |MChem|
Senior Consultant: UK Services
Belfast, UK
Frequently Asked Questions
Market access refers to the license to do business, or in other words, sell a product or service, in a particular market or jurisdiction. Often the market or jurisdiction is a country or state, but it can be further broken down by city, as well as even perhaps a private company with retail stores where you hope to sell your product. All of these ‘markets’ have their own set of rules for doing business.
Market access is a function of both trade law and other regulatory schemes with which you must comply, so considering both trade and compliance is critical to market access and often these two concepts are intertwined when assessing market access. H2 Compliance focuses on the regulatory compliance aspect of market access.
There are several key questions to ask yourself when assessing your market access and developing a regulatory compliance strategy:
- What current and future markets am I targeting?
- What is the product’s intended use?
- Are there technical specifications or regulatory specifications for the product I intend to sell?
- How much of the product do I intend to sell into a given market or jurisdiction?
- What kind of documentation and data will I need to collect to demonstrate compliance with local regulations?
- If expanding globally, what overlapping requirements exist that would make it easier for me to gain compliance in another new market?
Answering these key questions will help you identify what regulations apply to the product you intend to sell and how to comply with them. Identifying the applicable regulations and best strategy for moving forward is not always straightforward, but taking the time to ask these questions from the outset before jumping into a new market will set your business up for success.
If this process feels complicated, H2 Compliance experts can help you navigate to new markets globally. Contact us at info@h2compliance.com.
Missed or neglected compliance steps are one of the most common barriers to market access. Without proof of compliance, selling products into your intended market may become impossible.
Ensuring you have proper documentation well before your product is imported, manufactured, or sold in a new market is a critical step in gaining access. This documentation may take many different forms, including:
- Safety Data Sheets (SDS)
- Letters of conformity
- Compliance certification statements (with proper assessments to back up the certifications)
- Product labelling
- Registrations and/or notifications
Revisiting your initial market access assessment, regulatory strategy, and documentation regularly, as well as tracking regulatory developments in your given market(s) with help you maintain long-term access.