Omedik

Regulatory Science: Driving Your Product's Success

Transforming Regulatory Affairs into Scientific Excellence:

At OmeDik, we specialize in converting regulatory affairs into a scientific approach, essential for both the short- and long-term commercialization of your pharmaceutical and medical device products. Our comprehensive solutions provide scientific and commercial support, guiding you through the regulatory landscape and MINSA policy environment in Costa Rica.

Rusted Expertise, Certified Results

Complete Support for Medical Devices in Costa Rica

Our expertise covers the intricacies of Costa Rica and Central American regulatory affairs. We ensure your medical devices meet all regulatory standards, paving a smooth and efficient path to market.

Validator

Industry-leading validation software trusted by regulatory agencies worldwide, ensuring all submissions are technically and legal in compliance for a Marketing Application

TrackOmeDik

A versatile system for tracking product information and managing regulatory activities throughout the pharmaceutical product lifecycle. It provides instant access to information and generates management reports on-the-fly

Business OmeDik (The Automator):

Facilitates business process automation by handling rule- alerts for your product alerting critical dates such as renewals, post-approval applications, tender deadlines, and princes increase ensuring you never miss an important milestone

TVT® (Text Verification Tool®)

Ensuring precise text verification for your submissions.

DocOmeDik

An advanced electronic submission management and regulatory content management system, enabling easy compilation, publishing, importing, and reviewing of regulatory submissions. It supports eCTD, (V)NeeS, HTML, PDF, and paper formats, streamlining the submission process.

Regulatory Science

What Can We Do for You?

Delivering End-To-End Scientific and Regulatory Support and Solutions, we work closely with you to navigate the regulatory strategy and policy environment of MINSA in the region with a comprehensive tool to help navigate.

OmeDik Gap Analysis

We look out for relevant issues, trends, developments, and changes, and help you understand your product's resulting policy, standard, and legislation challenges to adapt your quality and specifications to the region.

Early Updates & Warnings

This service is designed to alert you to potential changes in any regulations, policies, or legislation that might pose high risks to your product within 48 hours. Our updates allow you to prepare for these changes, turn them into opportunities, and/or avoid losses.

Product Compliance

For a product to enter a market, it should comply with the regulations and conditions of the respective authorities.

The path to regulatory approval for biologics can be complex. Rely on our biologics experts to help you navigate it efficiently. With the growing innovation in immunotherapy and genomics, the number of biologics approved by MINSA has increased significantly.

The challenges related to the development and manufacturing of biologics are substantial. It's crucial to select a regulatory partner experienced in navigating this complex landscape to ensure a smooth path to approval. OmeDik Regulatory Services offers a comprehensive suite of regulatory resources to support the development, registration, and approval of biologic products.

We have implemented a digital system with cloud storage that allows direct access to your evaluation, meeting the highest standards, including those of the FDA.

We have successfully achieved regulatory approval for over 15 bioequivalent medicines in Costa Rica and are ready to assist you in obtaining your product registration. Our expertise in navigating the regulatory landscape ensures that your bioequivalent medicines meet all requirements for successful market entry

With more than 50 approved molecules, we have extensive experience in the regulatory processes for generic drugs. Our expertise in obtaining regulatory approvals ensures that your generic drug products meet all requirements for successful registration and market entry. Trust our proven track record to navigate the complex regulatory landscape and achieve compliance efficiently

Our expertise extends to the regulatory approval of medical devices across all categories (I, II, III, and IV). We have successfully navigated approvals for products from United Kingdom, Israel, Germany, Argentina, Mexico, South Korea, USA, and Canada. We ensure that your medical devices comply with stringent regulatory standards, including ISO classifications and specific requirements.

Trust us to guide your medical device through the complex regulatory processes to achieve market entry and maintain compliance with international standards

We assist you in obtaining the necessary registrations for food supplements and special regimen foods, ensuring compliance with regulatory standards. With extensive experience in products made in the USA, United Kingdom, Spain, Italy, Canada, Germany, South Korea, and other countries, we help you successfully introduce these products in Costa Rica

In Costa Rica, preparing a comprehensive regulatory dossier is crucial. Will your Chemistry, Manufacturing, and Controls (CMC) documentation meet complex regulatory compliance standards? OmeDik Regulatory Sciences has the qualified scientific and medical writing expertise to ensure your CMC documentation is complete and tells the right story.

We partner with you to develop your regulatory strategy and to prepare, review, and submit CMC documentation for all phases of development. We ensure that your drug product meets the regulatory compliance and quality standards of MINSA and regional health authorities.