Frequently Ask Question

Answer: Registration requires comprehensive product information, including technical specifications, safety and efficacy data, labelling, Good Manufacturing Practice (GMP) certification, and compliance with standards set by BPOM (for cosmetics and food & beverages) and Kemenkes (for medical devices). We manage all documentation to ensure full compliance.

Answer: We handle the entire process—documentation review, compliance assessments, and communication with BPOM, Kemenkes, and BPJPH. This minimizes complexity and ensures faster approvals for medical devices, cosmetics, food & beverages, and related certifications.

Answer:

Medical Devices           : Typically, 3-4 months

Cosmetics                      : Around 3-6 months depend on complexity of the product

Food & Beverages       : Typically, 4-8 months depend on complexity of the product

Halal Certification      : Depend on Manufacturer Location and readiness, can be up to a year, but may be process in parallel for certain categories

Timelines vary depending on product classification and complexity. We help expedite the process by ensuring all documentation is complete and accurate from the start.

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With over 9 years of experience in regulatory affairs, we help clients avoid common pitfalls, stay aligned with regulations, and achieve faster market entry.

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Clients can contact us via WhatsApp or through our website for an initial consultation. We conduct a compliance assessment and design a tailored regulatory approach based on product specifications.

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We specialize in:

• Medical Devices
• IDAK
• CDAKB
• Cosmetics
• PSB (Importer Recommendation / as Notification Applicant)
• Food & Beverages
• SMKPO
• Halal Certification
• BPOM Standard Certificate
• PKRT (Household Health Supplies)

Answer: Halal Certification, issued by BPJPH, confirms that a product complies with Islamic dietary laws. It is mandatory for most food, beverage, and cosmetic products in Indonesia. Certification ensures consumer trust and legal compliance.

Answer: The process includes:

• Preparing and submitting documents to BPJPH
• Auditing by an LPH (Halal Inspection Body)
• Review and approval by BPJPH

INSIGHTOF manages each stage to ensure smooth coordination and faster approval.

Answer: Yes, Halal Certification can run alongside BPOM registration for food, beverages, and cosmetics. This helps save time and speeds up market entry.

Answer: Common errors include incomplete documentation, incorrect product classification, and neglecting Halal requirements. Our pre-assessment services identify and resolve these risks early.

Answer: Importation requires:

• SKI (Import Certificate)
• LS (Surveyor Report)
• Valid BPOM product registration

  We assist in preparing and submitting all documents to ensure smooth importation.

Answer: Yes. We review and adjust product labels, nutrition facts, and claims to comply with BPOM regulations, ensuring approval without unnecessary delays.

Answer: IDAK certification ensures that medical devices meet legal distribution standards, protecting both distributors and consumers by ensuring only compliant products reach the market.

Answer: We provide expert review, preparation, and submission of regulatory documentation, ensuring each document meets BPOM and Kemenkes standards.

Answer: The process includes:

• Warehouse verification
• Facility inspection
• Submission of required certifications

  We manage each step to secure timely approval.

Answer: Medical devices must be stored and distributed under Good Distribution Practices, including controlled temperatures, secure warehouses, and documented procedures.

Answer: CDAKB certification requires a quality management system, proper storage, accurate record-keeping, trained staff, and successful facility inspections.

Answer: As a CRO, we assume legal responsibility for product registration, compliance, and importation on behalf of clients who do not have a local entity in Indonesia.

Answer: We manage BPOM registration, importation requirements, and ongoing compliance, enabling clients to legally distribute cosmetics without a local subsidiary.

Answer:

SMKPO (Sertifikat Mutu Cara Produksi Obat) certifies that pharmaceutical manufacturing facilities comply with Good Manufacturing Practices (GMP). We assist with documentation, facility readiness, and guidance throughout the BPOM certification process.

Answer: Yes. While our current focus is on Medical Devices, Cosmetics, Food & Beverages, and Halal Certification, we continue to assess opportunities to expand as regulations evolve and client needs grow.