Regulatory Affairs Services in Kenya
The Pharmacy and Poisons Board (PPB) is the Kenyan government authority responsible for the oversight of the manufacture, regulation, and trade of medicines and poisons. It enforces the Pharmacy and Poisons Act to ensure public access to safe, efficacious, and high-quality medications. In 2010, the PPB adopted the more stringent Common Technical Document (CTD) format, recognized by the World Health Organization (WHO), which requires detailed safety, efficacy, and quality data. As a member of the East African Community (EAC), Kenya is advancing global regulatory harmonization and serving as a model for other EAC members. However, implementing the CTD format has led to fewer product registrations, as many local manufacturers cannot provide the required documentation. Consequently, the Kenyan market now has more unregistered products that don’t comply with Good Manufacturing Practice (GMP), placing additional burdens on the PPB. All of this reinforces the need for strong Regulatory Services in Kenya, especially for Regulatory services in PPB.
Why choose DDReg’s Regulatory Affairs Consulting in Kenya?
DDReg, a leading global provider of Pharmaceutical Regulatory Affairs Services in Kenya, offers full-spectrum regulatory strategy consulting in Kenya across every stage of product development and registration. We stay uptodate with evolving Kenyan and WHO standards to ensure high-quality, compliant, and timely submissions. With a focus on regulatory affairs consulting in Kenya, we implement robust safety and riskmitigation protocols. Our team of experts collaborates across functions to streamline product launches, regulatory filings, and market authorizations.
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- Regulatory Labelling
- eCTD Publishing and Submission
Our Regulatory Affairs Consulting Services in Kenya 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...
