OUr Services
Regulatory Affairs
We help companies understand, plan, and implement the regulatory and quality requirements needed to operate safely and compliantly. Our work is structured to fit your company’s own practices, and we support you through each stage of the regulatory and quality process.
We usually begin by addressing your immediate questions or concerns. From there, we help you build a long-term approach that aligns with the relevant regulations, standards, and market expectations. Our goal is to help you integrate compliance into your daily operations in a practical way.
Regulatory Affairs
Strategic regulatory support across all classes of medical devices and related technologies.
We support companies across all classes of medical devices, IVDs, complementary medicines, and related technologies. Our role is to help you identify what is required, understand how to meet those requirements, and ensure that your documentation and systems are correctly maintained.
We help you determine which regulations and standards apply to your product, both locally and internationally. This includes product classification, market-specific requirements, and identifying the regulatory frameworks relevant to your intended markets.
We assist in drafting, structuring, and compiling complete technical files. We also create strategic management plans for files and regulatory systems and provide ongoing support as products evolve or new requirements arise.
Strategic Regulatory Planning & Scoping
- Identify which regulations and standards apply based on product classification, intended use, and target market.
- Determine applicable SAHPRA, international, and market-specific regulatory frameworks.
- Establish clear regulatory pathways before submission to prevent costly rework.
- Develop structured regulatory strategies aligned with product lifecycle stages.
- Create realistic timelines for licensing, certification, and technical documentation readiness.
Project Management & Mentoring for Sustainable Compliance
- Manage full regulatory projects for companies lacking internal regulatory capacity.
- Coordinate communication with SAHPRA, notified bodies, and conformity assessment authorities.
- Compile and structure submission dossiers and technical files.
- Provide mentoring to executives and regulatory teams for long-term internal capability.
- Ensure sustainable regulatory compliance beyond initial approvals.
End-to-End Advisory & Process Implementation
- Provide expert interpretation of regulatory requirements and procedural obligations.
- Assist with drafting and compiling compliant technical documentation.
- Define and implement regulatory procedures within existing Quality Management Systems.
- Develop practical internal workflows aligned with ISO 13485 and SAHPRA expectations.
- Reduce administrative burden by translating regulatory requirements into actionable company processes.
Regulatory Affairs FAQ
Regulatory Affairs ensures that medical devices, IVDs, and related healthcare technologies meet all applicable legal, safety, and quality requirements before and after market entry. It includes classification, documentation preparation, licensing, and communication with regulatory authorities.
Regulatory planning identifies applicable standards, risk classifications, and market-specific requirements before submission. This prevents unnecessary delays, rejected applications, and costly corrections later in the process.
The correct pathway depends on product type, intended use, risk class, and target market. A structured scoping exercise determines which regulations and conformity assessment requirements apply to your product.
Yes. Full project management support includes compiling documentation, structuring technical files, and coordinating communication with SAHPRA or other regulatory bodies.
Yes. Mentoring helps your internal team understand regulatory requirements, implement procedures correctly, and maintain compliance independently while still having access to ongoing expert support.
Contact Us with your questions
Clarity Before Compliance Becomes a Problem. Book your first hour free consultation and understand exactly where you stand.