Regulatory Affairs Services Provider in South Africa
Regulatory Affairs Services in South Africa are crucial for ensuring that pharmaceutical products meet the necessary safety, efficacy, and quality standards. The South African Health Products Regulatory Authority (SAHPRA), under the Department of Health, serves as the national regulatory body overseeing all activities related to the registration, monitoring, evaluation, and inspection of medicinal products, including drugs, biologics ,medical devices, and in vitro diagnostics.
SAHPRA works in collaboration with various committees and organizations to streamline the regulatory processes. These partnerships include the International Pharmaceutical Regulators Programme (IPRP), which promotes regulatory cooperation among members, and the African Medicines Regulatory Harmonization (AMRH) initiative, which enhances the unified regulation of medicinal products across Africa. These efforts aim to ensure the availability of safe and efficacious medicines to the public in an efficient manner.
Why choose DDReg as your Trusted South Africa Regulatory Consultant?
As a leading Regulatory Affairs Services Provider in South Africa, DDReg offers comprehensive support across all regulatory phases, delivering customized strategies tailored to meet the evolving regulatory requirements. Our SAHPRA Regulatory Affairs Consulting services are designed to assist you in navigating South Africa’s drug registration and approval process, ensuring high-quality and timely submissions for market authorization.
We focus on delivering reliable safety measures, risk mitigation, and seamless product launch facilitation. Our expertise in SAHPRA regulatory affairs ensures that your regulatory filings meet all necessary compliance standards and result in successful market entry and approvals. From initial product submission to post-approval management, we are your dedicated South Africa regulatory consultant for all your pharmaceutical needs.
Our Regulatory Consulting Services In South Africa Portfolio Covers
- SAHPRA Regulatory Support
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- • API/DMF
- Marketing Authorization Holder Services/li>
- eCTD Publishing and Submission Services
- Regulatory Labeling Services
Our Regulatory Affairs Consulting Services in South Africa portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
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...
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...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
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...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
