Regulatory Affairs in healthcare industries is vital in making safe and effective healthcare products available worldwide.
The Regulatory Affairs department integrates highly qualified and motivated professionals, who have the know-how on the various areas of Regulatory Affairs and seek perfection and total satisfaction on every single activity requested by our clients.
• Advice on regulatory requirements and strategy;
• Regulatory compliance;
• Access to National Agencies / Notified Bodies;
• Evaluation of data;
• Licensing opportunities;
• Client in-house Support.
• National / European Marketing Authorizations Applications;
• Complete preparation of Marketing Authorization Applications Dossiers for Human
Medicines in accordance with Common Technical Dossier format:
Module 1, Module 2, Module 3, Module 4 and Module 5 (eCTD/Nees format);
• Integrated Summaries, Safety Updates;
• Variations, SPC, PIL, Labelling, Agency Responses;
• Quality Overall Summary (Module 2.3.);
• Readability Testing;
• Mock-up revision;
• Review of documentation of Health Products;
Interaction with Regulatory Agencies
• Submission of Applications for National / European Marketing Authorizations;
• Submission/Registration of Health Products;
• Follow up to approval using National, Mutual Recognition, Decentralized or Centralized Procedures;
• Appeals and Hearings;
• Client/Agency meetings.
• Training courses in Regulatory Affairs;
• Training courses on specific products/ groups of products for Marketing and Sales Forces.