Services and Scope
Pre Submission Consultation
Classification Application
When the same product gets classified different across different regulatory authorities, it is best to seek a response from the FDA before making a submission. This ensures a correct regulatory pathway is followed.
Due Diligence and Gap Analysis
Due Diligence and Gap Analysis
Whether it is a MA Transfer or a takeover, we work with your team to provide all the required due diligence needed to ensure that transactions are safe.
Providing a Gap Analysis for your Dossiers, in line with the expectations of the HA, before actually proceeding with a regulatory submission.
Dossier Preparation
Each regulatory authority has their own expectation on how they want to receive submissions. Whether a bookmarked document for Philippines or a pre-defined folder structure for Myanmar, or maybe a translated Normative Document for Uzbekistan, a eCTD for Thailand, we help clients in meeting the regulatory expectation.
MA/ Registration Filing
Maintaining local license and compliance, filing on your behalf as a local applicant, we not only ensure that your registrations are in safe hands but also ensure that your intellectual property is well protected. Whether it be Drug or Medical Device - Food or Cosmetics, we handle them all.
MA Holding
Post registration, till you want, we offer to keep your MA on our license / provide FDA Agent Services. This not only ensures that you remain in complete control of your MA without actually having to set up locally, and also prevents a commercial distributor dispute spilling over your MAs.
QPPV and Pharmacovigilance
Depending on the regulatory requirement, we act as a QPPV until you decide otherwise. This not only ensures compliance to local regulations but also saves excessive cost towards your operations. Collecting cases and reporting ADE are also supported.
Life Cycle Management
Post approval changes, variations - major or minor, we undertake all of these. Ensuring your MAs remain up-to-date and renewals are filed on time, we let you focus on your other objectives while we handle the regulatory goals.
Delivering.
The Right Solution.
Offering Pre to Post MA handling, and management, we ensure that regulatory requirements are met and our clients Intellectual property is always secured.
Meeting Expectations.
Whether it is a Takeover Due Diligence or a Gap Analysis for HA submission, we work each step with your team to ensure that products gets to the market.
MA/Registration Services
With boots on ground across West, CIS and APAC, we provide local MA services. While you remain the owner of your intellectual property and registrations, we act as a local legal applicants and FDA agents.