As a global regulatory and technical specialist that provides end-to-end regulatory and compliances services
Find Out MoreAs a global regulatory and technical specialist that provides end-to-end regulatory and compliances services across lifecycle management from product development (R&D, Pre-clinical, Clinical Trials) to registration and post approval compliance. In the past 12 years, we have a proven track record of successfully navigating the evolving regulatory environment across a wide range of innovative therapeutics for quality, speedy, cost-effective approvals (biological, clinical, herbal/nutraceutical, device/diagnostics, cosmetics, veterinary, etc.)
Our regulatory intelligence professionals have access to relevant regulatory agencies and have the expertise to summarize and assess global regulatory intelligence to ensure submissions are compliant with evolving regional and local requirements, reducing the impact of re-work on budgets and timelines.
Our clients are provided with reliable and accurate global regulatory information to gain competitive advantage and minimize regulatory risks. We help clients with timely and informed decisions
Our technical and medical writing team is uniquely qualified to help clients to collate, organize, write, edit, and create an extensive range of medical and scientific regulatory documentation required to support product development & Life Cycle Management. Our Team has the expertise and experience to support dossier submissions across the globe in various formats (eCTD, CTD, NeeS, national, ASEAN etc.)
We provides end to end services on the labelling requirement that includes Art work and Due Diligence of existing labels for regulatory compliance. We provide complete support in preparation of new labels for Clinical trials, Medical devices, Food & Dietary Supplements & finished formulations labels, in accordance with the Global & regional requirements.
The effective supervision, compilation and submission of electronic dossiers is a complex process. The submissions team at Abba Pharma Ltd is equipped with comprehensive knowledge of the evolving global Regulatory guidelines and has experience with review and gap analysis of regulatory documents, medical and technical writing, along with the relevant software knowledge in publishing and submissions leading to quality, speedy approvals of regulatory compliant dossiers.
The initial approvals secured for market access is invaluable to the Biopharmaceutical Company and its investors. Maintaining post approval regulatory compliances is critical to retain the product in the market with a competitive label claim throughout its life cycle and has value for in and out licensing opportunities.