ASA-SANTHILL’s interest is on consulting relating to product development strategy, regulatory requirements, post approval services and manufacturing outsourcing. Anthill staff has the knowledge and experience to understand and proffer solution to different regulatory scenarios. We can assist our client at all stages of product development, from conception to registration and post registration.

We have also been involved in a number of turn-key projects in Pharmaceuticals and Food manufacturing.

Our wealth of experience and expertise cut across a wide range of pharmaceuticals, devices, cosmetics and food products. Till date we have handled marketing authorization of around 300 products, including, oncology, anti-diabetic, anti-hypertensive, analgesics, anti-ulcer, fertility drugs and diagnostic device among others. We also have staff with vast experience in the food products regulation that are committed to making sure that project in food get the needed attention all the time.

Areas covered by ASA-ANTHILL’s regulatory affairs consulting include:

Project management
• Regulatory project planning
• Monitoring of project progress
• Project status report

Regulatory affairs
• Development of a regulatory strategy
• Interpretation of guidelines & regulatory requirements
• West coast regulatory intelligence
• Process validation
• Agency Interactions
• Requirements for setting up a manufacturing facility
• Post registration regulatory requirements

Manufacturing outsourcing
• Sourcing for local, or foreign manufacturing facility for clients wishing to go into toll manufacture
• Raw and packaging material outsourcing

Post Registration Consulting Service
One of the primary objectives of ASA-ANTHILL as a consulting firm is to give our clients product idea life. We can support a client’s project at any stage with the view to successful marketing authorization. Once approval has been obtained, a marketing authorization requires continuous monitoring, in order to ensure that the conditions of the approval are being met. Moreover there may be post approval variation to the marketing authorization, or the need to improve on the quality of authorized product, or introduction of other variants.

ASA-SANTHILL’s post-approval services include:
– Development of strategies for post-approval variations to the marketing authorization.
– Monitoring of post-approval commitments and responses to on-going questions.
– Post-approval agency interactions.
– Compilation and submission of responses to on-going commitments, and variation dossiers
– Post-Product Registration/Market Intelligence services
– Periodic, independent and unbiased market research to determine product progress in the market and the leading brands.
– Quarterly Market analysis for all the registered brands of company’s Product.
– Product advice based on market research findings
– Liaise with Regulatory Agency for regulatory updates and advise on strategy for way forward