Regulatory Affairs Services in Indonesia
The Indonesian authorities responsible for regulating drugs, biologicals, and medical devices are the Ministry of Health (MoH) and the Indonesia National Agency of Drug and Food Control (BPOM). The BPOM oversees the authorization of drugs and biologicals, while the MoH regulates medical devices. Indonesian-based organizations can apply for marketing authorizations for medicinal products. The requirements for drug development and testing are different for generic versus new products. The BPOM accepts clinical and non-clinical trial results for new drug products that have been conducted overseas as part of the marketing authorization procedure in Indonesia, which is conducted online via the Risk-Based Approach Online Single Submission (RBA OSS) system. It is imperative for applicants to be registered in the RBA OSS system before they can be granted marketing authorization. This also applies to medical devices that are required to obtain a Medical Devices Manufacturing Certificate for local manufacturers or a Medical Devices Distribution Certification for importers.
Why choose DDReg as a Regulatory Consultant in Indonesia?
As a leading regulatory service provider in Indonesia, DDReg offers comprehensive regulatory services that support the development of tailored strategies during all regulatory phases. We remain aligned with the most current regulatory requirements to ensure high-quality and timely submissions. Our solutions include robust safety measures, proactive risk mitigation, and seamless collaboration with subject matter experts to facilitate efficient product launches, regulatory filings, and market authorizations.
Our Regulatory Consulting Services In Indonesia Portfolio Covers
- BPOM Regulatory Affairs Consulting
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API -DMFx
- MA Holding Services
- Regulatory Certification Services
Our Regulatory Affairs Consulting Services in Indonesia portfolio covers:
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
04
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
05
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
06
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
07
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
10
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
