Regulatory Affairs

REGULATORY AFFAIRS

Pre Submission Consultation
This is a great chance to get feedback from the FDA before you submit your premarket application. It can save you time and help steer your product development or submission prep in the right direction.

Classification Application
When a product is classified differently by various regulatory bodies, it’s wise to reach out to the FDA for clarification before you submit. This way, you can ensure you’re following the correct regulatory path.

Due Diligence and Gap Analysis
Whether it’s a market authorization transfer or an acquisition, we collaborate with your team to conduct thorough due diligence, ensuring that all transactions are secure. We also provide a Gap Analysis for your Dossiers, aligning them with the expectations of the health authorities before you move forward with any regulatory submissions.

pharmacist

Dossier Preparation
Every regulatory authority has its own requirements for submissions. Whether it’s a bookmarked document for the Philippines, a specific folder structure for Myanmar, a translated Normative Document for Uzbekistan, or an eCTD for Thailand, we’re here to help our clients meet those regulatory expectations.

Registration Filing
We take care of your local licensing and compliance needs by filing on your behalf as a local applicant. With us, your registrations are in good hands, and your intellectual property is well protected. Whether it’s for drugs, medical devices, food, or cosmetics, we’ve got you covered.

MA Holding
After registration, we can keep your Marketing Authorization (MA) under our license or provide FDA Agent Services for as long as you need. This way, you maintain full control of your MA without the hassle of setting up locally, and it helps avoid any disputes with commercial distributors regarding your MAs.

QPPV and Pharmacovigilance
We can serve as your Qualified Person for Pharmacovigilance (QPPV) based on regulatory requirements until you decide to make a change. This not only keeps you compliant with local regulations but also helps you save on operational costs. We also support case collection and reporting of Adverse Drug Events (ADE).

Life Cycle Management
We handle all post-approval changes and variations, whether they’re major or minor. By ensuring your MAs are up-to-date and that renewals are filed on time, we allow you to focus on your other goals while we take care of the regulatory aspects.

Lab Testing
Our testing services are all about making sure that pharmaceutical products are top-notch in quality, safety, and effectiveness. We offer a variety of analytical tests to confirm the identity, purity, and strength of drugs, along with checks for microbial contamination and stability.

CLIENT REVIEWS

Here's what our customers has to say!