Answer: Clients need to provide detailed product information, safety and efficacy data, manufacturing processes, and compliance with standards set by the Ministry of Health (Kemenkes) and BPOM. We assist in preparing and submitting these documents to ensure compliance.

Answer: We simplify the regulatory process by providing expert guidance, managing documentation, and liaising with regulatory bodies, saving our clients time and effort while ensuring compliance.

Answer: Clients may encounter challenges such as complex documentation requirements, strict regulatory standards, and lengthy approval times. Our expertise helps navigate these challenges efficiently.

Answer: The duration can vary based on product complexity and regulatory requirements. We strive to expedite the process by efficiently managing documentation and communications with regulatory authorities.

Answer: We have a broad of experience in regulatory affairs for medical devices and cosmetics, for more than 5 years, enabling us to provide expert guidance and support throughout the compliance process, ensuring smooth and efficient approvals.

Answer: Clients can start by contacting us through our contact number or email or website. Our team will provide an initial consultation to understand their needs and develop a tailored plan to meet regulatory requirements.

Answer: We primarily serve the medical device and cosmetics industries, helping manufacturers, distributors, and importers navigate regulatory compliance in Indonesia.