Regulatory Services
Regulatory Affairs is pivotal in supporting the commercialisation of product through compliance with country, regional and global regulations.
REGULATORY AFFAIRS
Regulatory Compliance From Development to Market
We help ensure your organization is prepared for pre-market market placement, and post-market regulatory activities, covering the statutory and regulatory requirements issued by recognized government authorities.
- Medical devices and medical equipment
- Pharmaceuticals
- Cosmetics
- Agricultural seeds and fertilizer
- Milk and dairy products
Regulatory Risk Assessment
We perform regulatory risk assessment through disciplined stages to help your organization through its product life-cycle. Organizations operate in increasingly complex regulatory environments where new legislation, evolving standards, and changing stakeholder expectations can significantly impact products and services. A disciplined regulatory risk assessment enables organizations to make informed decisions, maintain compliance, and build confidence with regulators, customers, and investors.
Here is what we action for you
- Identify applicable regulations and regulators
- Assess compliance requirements for the product
- Evaluate risk
- Analyze and Prioritize Risks
- Develop mitigation measures
- Implement Controls and Evidence Compliance
Benefits of a Disciplined Regulatory Risk Assessment
By following a structured regulatory risk assessment process, organizations can:
- Identify regulatory obligations early in the product lifecycle.
- Reduce the likelihood of regulatory breaches and enforcement actions
- Prioritize compliance resources based on risk.
- Demonstrate due diligence and effective governance.
- Improve decision-making through evidence-based risk analysis.
- Enhance customer, regulator, and stakeholder confidence.
- Support successful product launches and market expansion.
- Build resilience in an evolving regulatory environment.
Stay Ahead of Changing Regulations
From pre-market approval to post-market surveillance, we help you meet regulatory requirements with confidence at every stage.
Frequently Asked Questions
Here are some of the questions we’re asked most often about regulatory compliance and market authorization.
Medical devices and equipment, biotechnology, pharmaceuticals, cosmetics, agricultural seeds and fertilizer, and milk and dairy products.
Yes including software as a medical device, combination products, artificial intelligence, hazardous substances, and packaging waste.
We compile and submit product listings, dossier applications, and import permit applications on your behalf, and lead internal audits to keep you compliance-ready.
We support on-going market surveillance and reporting, so your organization retains its market authorization and stays ahead of regulatory change.
• Regulatory risk assessment
• Define, implement and maintain regulatory requirements for business
• Provide regulatory product assessment for Research and Development
• Define Product Risk Classification
• Define applicable Clinical Trial Regulatory Affairs requirements
• Compile and submit applications for Product listings to regulatory bodies
• Compile and submit dossier applications to regulatory bodies
• Manage and submit applications for Import Permit
• Lead, perform and manage internal statutory compliance audits
• Manage product complaints and vigilance reporting
• Deliver on optimization of RA processes and systems
• Deliver on staff Training and Education
• Perform special projects directed by your business to include digital capabilities
Practical regulatory support from pre-market to post market.
