Regulatory Affairs Service Provider in Colombia
The Colombia National Food and Drug Surveillance Institute (INVIMA), known as Instituto Nacional de Vigilancia de Medicamentos y Alimentos, was established in 1992 under the Ministry of Health. It plays a key role in regulating drugs, medical devices, and biologics within the country. INVIMA conducts periodic inspections often triggered by anonymous complaints or authoritative directions, to ensure regulatory compliance.
Due to a detailed evaluation process, INVIMA regulatory affairs processes often take longer to grant new product marketing authorization.Innovator products generally undergo longer review times compared to generics or drugs listed in the Official Pharmacopeia. Similarly, biologics and biosimilars may also face longer timelines unless an abbreviated route is applicable, depending on the molecule’s profile. This can accelerate the process of obtaining product registration in Colombia.
Why choose DDReg’s Regulatory Affairs Services in Colombia?
DDReg offers strategic and compliant regulatory affairs services in Colombia, customized to each phase of the product lifecycle. We continuously monitor regulatory changes and apply proactive compliance strategies to ensure timely and high-quality submissions.
Our team provides full-spectrum regulatory support for product registration in Colombia, including collaboration with local stakeholders and regulatory experts. We focus on risk mitigation, submission accuracy, and seamless execution to help clients achieve faster market access. With DDReg as your Colombia regulatory affairs consultant, you gain a trusted partner for regulatory navigation, product approval, and lifecycle management under INVIMA regulations.
Our Regulatory Consulting Services In Colombia Portfolio Covers
- INVIMA Regulatory Consulting Services
- 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 Certification
- eCTD Regulatory Publishing and Submission
- Regulatory Labeling
Our Regulatory Affairs Consulting Services in Colombia 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...
