Our Services

With The Reg Solution as your local regulatory partner, you gain access to deep industry knowledge, expert compliance support, and a commitment to helping your business thrive in ASEAN markets. We are dedicated to being more than just a service provider – we’re your trusted ally in achieving regulatory excellence.

Pre-Market  Regulatory Services

Our pre-market services ensure that your products are strategically positioned and fully compliant with local regulations from the start. With our deep knowledge of regulatory requirements in Singapore and ASEAN countries, we help you lay a solid foundation for successful product launches.

Product Registration and Notification

  • Pharmaceutical Drugs RegistrationWe provide comprehensive services, including pre-submission consultation, dossier preparation, submission management, and post-approval maintenance. Our expertise encompasses the local regulations, ensuring that your pharmaceutical products meet all safety, efficacy, and quality standards. Partner with us to streamline your drug registration process and bring your innovations to market efficiently.
  • Cosmetic product notificationWe specialize in ensuring that your cosmetic products meet all necessary legal requirements for market entry and compliance. We offer comprehensive services, including product formulation assessment, safety evaluations, and the preparation of necessary documentation for cosmetic product notifications. We assist clients in navigating complex regulatory frameworks, ensuring that your products adhere to local guidelines. From labeling compliance to ingredient restrictions, we provide the support you need to confidently bring your cosmetic innovations to market.
  • Health Supplements RegistrationOur team navigates the complex landscape of health supplement regulations to ensure your products meet all necessary compliance standards. We provide comprehensive services, including regulatory strategy development, document preparation, submission management, and post-market surveillance. Our in-depth knowledge of local regulations allows us to facilitate a smooth registration process, minimizing time to market while ensuring your health supplement is safe and effective.
  • Medical Device RegistrationWe assist medical device companies with regulatory strategy development, pre-market submissions, compliance assessments, clinical evaluation support, and liaison with regulatory bodies. With a deep understanding of regional regulations, we ensure that your products meet all necessary requirements for a successful market entry.
  • Traditional and Chinese Medicine RegistrationWith a deep understanding of the unique regulatory requirements for traditional and Chinese medicines, we offer comprehensive support, including product evaluation, safety and efficacy assessments, preparation of registration documents, and communication with regulatory authorities. We ensure that your products meet the necessary standards for quality and safety, facilitating a smooth registration process.

Post-Market  Regulatory Services

Post-market services are essential for maintaining compliance and ensuring your products continue to meet regulatory standards after approval. We offer tailored services to support you throughout the product lifecycle.

Licence Holding

For overseas clients without a local entity, we serve as the legal licence holder, ensuring compliance and adherence to local regulations, while enabling you to focus on your core business.

Lifecycle Management

  • Product Renewals and VariationsWe assist businesses with post-market product renewals and variations to ensure your products stay compliant with evolving regulatory requirements. We provide comprehensive support in preparing and submitting renewal applications, managing variations due to changes in formulation, packaging, or labeling, and addressing regulatory inquiries from health authorities.
  • Change NotificationsOur team is committed to ensuring compliance with regulatory requirements following changes to your medical devices. Our services include assessment of significant changes, preparation of required documentation, submission coordination, and ongoing support to maintain market access. Stay compliant and mitigate risks associated with post-market changes with our comprehensive regulatory guidance.
  • Marketing Authorization transferWhether you're transferring marketing authorisation due to mergers, acquisitions, or restructuring, we simplify the process, handling all necessary documentation and liaising with regulatory authorities. Trust us to ensure a seamless transition while safeguarding your product's approval status, in-depth market knowledge, and tailored support that aligns with your business objectives.
  • Market Recall ManagementWe understand that product recalls can pose significant challenges for businesses in the regulatory landscape. Should any product recalls be necessary, we handle the recall process swiftly and professionally, liaising with authorities and managing all communication with timely and compliant execution.
  • Regulatory Operations SupportOur expert team assists with various critical processes, including Certificate of a Pharmaceutical Products (CPP) applications, Free Sales Certificate (FSC) applications, Import and Export Permit applications, and strategic guidance tailored to your specific needs. We ensure that your products meet all regulatory requirements, facilitating smooth market entry and compliance with local laws. From initial document preparation to final submission and follow-up with regulatory authorities, we are committed to streamlining your operations and enhancing your organization's success.

Regulatory Affairs Consulting

Our consulting services are designed to empower your team with the regulatory knowledge and resources needed to thrive in the ASEAN region.
  • Regulatory Advisory and StrategyWe provide comprehensive regulatory affairs consulting services designed to guide you through every stage of your product lifecycle. Our expert team offers tailored solutions that include submission strategies, regulatory pathway assessments, and post-market surveillance compliance. With a deep understanding of local regulatory frameworks, we ensure you remain compliant while focusing on innovation and growth.
  • Artwork and Marketing Material ReviewWe provide meticulous review of artwork and marketing materials to ensure compliance with industry regulations. Our experienced team is dedicated to helping you navigate the complex landscape of regulatory requirements, ensuring that all promotional content—whether labels, advertisements, or packaging meets the latest legal and industry standards. We conduct thorough evaluations to identify potential compliance issues, provide actionable feedback, and help you streamline your approval processes, ultimately minimizing risk and enhancing brand integrity.
  • Daily Regulatory Support with Subscription PlansWe provide unparalleled daily regulatory support to ensure your business remains compliant and informed. With our subscription plan, you gain access to continuous guidance, timely updates on regulatory changes, and tailored support for your specific needs. Our services include document preparation, regulatory submissions and strategy development to facilitate your product approvals and market access. Choose our subscription plan for peace of mind and focus on what you do best—growing your business.