Customers across
5 continents

Global Reach

In our quest to expand access to high-quality generic medicines at affordable prices, we continue to increase our reach to newer markets and geographies. With a growing number of accreditations, the International Business of SAVA Healthcare Limited offers clients a portfolio of Pharmaceuticals, Herbals and Animal Health products.

Our core business regions are:

  • Canada
  • Ukraine and the CIS
  • Asia
  • Africa, especially FWA

Regulatory Affairs

Our Regulatory Affairs team keeps track of the ever-changing legislations in all the regions in which the company intends to market its products. We are capable of all types of regulatory submissions (Dossiers / ANDA / ANDS / CTD / e CTD) for any of the semi-regulated to highly regulated markets ensuring fast turnaround in business.

Accreditations

Products

Our human pharmaceuticals include:

Nasal Sprays

Dry Powder Inhalers

Oral Solids

Topicals

Services

Dossier development as per CTD / ACTD requirements.

Artwork / product labeling development as per country’s requirement.

Accurate and specific Analytical and Chemical, Manufacturing and control (CMC) data support.

Indian FDA documents support, required for product registration.

GMP audit assistance.

Interactions with regulatory authorities as and when required.

Regulatory compliance gap analysis and solution.

On time product registration renewal.