Regulatory isn’t just about preparing dossiers – its about making sure that they are compliant in the first place, prepared and submitted in a timely manner, and then followed up on with the individual Authority to ensure that your dossiers is reviewed and approved as quickly as possible. We keep on saying – time is money !
Amacol will also advise on regulatory strategy. Where first ? Sometimes the less regulated markets look like quick wins, but the pricing in these markets and influence the pricing you may be given in the more important (and highly regulated) markets. A number of factors need to be considered when choosing your strategy, and Amacol has the experience to make sure you make the correct choice.
Amacol reduces the time to submission and approval by being more hands-on :
• Compliance check of existing dossier to flag any potential challenges at an early stage
• Assistance in compilation of site applications (if required by Authority)
• Assistance in compilation of product dossier. Includes reformatting of Module 1 for target markets.
• Co-ordination of submission appointment with distributor regulatory manager
• Follow-up with Authorities, assistance in responding to deficiency letters
• Variations and renewals
Dossier review, API source, stability, alcohol, bovine, manufacturing site approvals, MA status, etc.
Should you prioritize based on ease to market (regulatory), the size of the market or the expected pricing ? We bring it all together to help you choose the right regulatory strategy.