Dossier Licensing & Product Supply
We support dossier registration in regulated markets including Europe, United Kingdom
(MHRA), United States (USFDA), Canada, South Africa, and Australia (TGA).
We also handle registrations in emerging markets such as Latin America, Southeast Asia,
Africa, GCC, and CIS countries.
Once approval is secured, we coordinate manufacturing and supply of commercial batches.
Supply Of Chemicals & Active Pharmaceuticals​
We have long-term associations with reliable manufacturers of chemicals and APIs.
This ensures consistent quality and competitive pricing for our customers.
Contract Manufacturing
- Support for site transfer and technology transfer projects.
- Execution of validation batches and generation of stability data.
- Commercial manufacturing and supply at cost-effective terms.
Contract R&D and Product Development
- Formulation development based on client specifications.
- Support and guidance for bioequivalence (BE) studies.
- Preparation and compilation of registration dossiers in ACTD, CTD, and eCTD
formats.
Patent Strategy & Non-Infringing Formulations
Our regulatory and IP teams work together to develop non-infringing formulations and
evaluate market opportunities for products under patent landscape review.
Regulatory Affairs
Our Regulatory Affairs team has over 15 years of experience across global markets.
We are well-versed in guidelines of USFDA, MHRA (UK), EMA (EU), TGA (Australia),
Health Canada, MCC, GCC, CIS, and Southeast Asian authorities.
Our team manages:
- Compilation of ACTD, CTD, and eCTD dossiers.
- Communication and query responses with regulatory authorities.
- Coordination to ensure timely approvals and marketing authorizations.
Intellectual Property Management Cell
Our IP Management Cell is staffed with experienced professionals in pharmaceutical sciences
and patent regulations.
We provide:
- Patentability assessments.
- National and international patent filing support.
- Strategic input for product portfolio planning and regulatory filing pathways.