Regulatory Affairs | Our Services - QbD Group

Regulatory Affairs Services

Your regulatory expert in East Africa

Get your product to market with confidence through expert Regulatory Affairs support. From strategy to product approval, we offer tailored services to navigate complex requirements and meet global standards.

Whether it’s compiling technical files, managing dossiers, or coordinating with regulatory bodies, we handle the details so you can focus on innovation. Keep your business compliant and competitive with Labmark by your side.

Discover our regulatory services

Expertise

Dedicated professionals with an in-depth understanding of regulatory requirements and industry challenges.

Tailor-made

Every project is unique, and so is our approach. We customize strategies to suit your goals, market, and timelines.

Always up to date

Regulatory landscapes evolve fast. We ensure you’re ahead of the curve with the latest insights and updates.

Field experience

Consultants with extensive field experience, including electronic submissions.

Market trends & challenges

The regulatory landscape is constantly evolving, making compliance more complex and critical than ever. Tightened regional regulations demand precision and attention to detail, with stricter requirements for technical documentation, labeling, and product lifecycle management. Keeping pace with these changes is essential for avoiding delays and maintaining market access.

Emerging technologies and innovative products, such as combination therapies and medical devices, add further layers of complexity to regulatory processes. Navigating these intricacies requires specialized expertise and a proactive approach to ensure timely approvals.

Globalization also increases regulatory challenges, with companies needing to manage compliance across multiple markets. A strategic, unified approach to regulatory affairs is vital for staying competitive while meeting diverse requirements.

Regulatory Affairs experts provide the insight and support you need to navigate these challenges effectively, ensuring compliance and empowering you to bring products to market without delays.

Explore our services

Regulatory Affairs Our Services - QbD Group-1

Our offerings for Regulatory Affairs

Early Development

We can maximize your success by leveraging our expertise in regulatory consultations and strategic planning for First-in-Human trials.

Scientific Advice

Seeking scientific advice or protocol assistance during drug development offers numerous benefits. Our regulatory experts can help you to interact with the required...

Submissions

Irrespective of the type of your regulatory procedure your applications for marketing authorization must be accompanied correctly by the required documentation.

eCTD Publishing

The skills needed to confidently compile electronic submissions can take years of training, industry immersion and regulatory study. Let us be your guide for electronic...

Regulatory Intelligence

Regulations and standards may change every now and then, and manufacturers must be aware of those changes. Our consultants keep you on track at all times.

RA Strategy for MD & IVD

Our tailored and strategic approach will help guide your organization through the complexities of regulatory frameworks, ensuring a smooth journey from development to...

RA Design & Development

Embark on your journey by conceptualizing your IVD or MD. We will assist you in navigating the intricate landscape of design and development, ensuring that your product...

Technical Documentation

We can support the writing and compilation of IVDR/MDR-compliant technical documentation in line with your notified body’s specific expectations.

Notified Body Submissions

Navigating the submission process can be daunting, but you don't have to do it alone. Our experts can prepare and submit your application to the notified body, ensuring...

Post-Market Surveillance

Post-Market Surveillance (PMS) is a vital component of maintaining product safety and efficacy once your IVD is on the market. We will assist you in developing a...

Why Labmark?

At Labmark, we don’t just understand regulatory challenges—we solve them. With over a decade of experience and a team of +50 experts, we offer end-to-end support for your Regulatory Affairs needs.

What sets us apart?

Specialized expertise: Deep knowledge of regional and global regulatory frameworks.
Tailored strategies: Customized approaches that fit your product and market.
Global reach: Localized insights with international scalability.
Proactive updates: Always ahead of regulatory changes to keep you compliant.

Partner with Labmark to simplify compliance and accelerate your journey to market success.

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