Regulatory Affairs

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.

Consultancy

• Advice on regulatory requirements and strategy;

• Regulatory compliance;

• Access to National Agencies / Notified Bodies;

• Evaluation of data;

• Licensing opportunities;

• Client in-house Support.

Document Preparation

• 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;

• Translations.

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.

Technical Training

• Training courses in Regulatory Affairs;

• Training courses on specific products/ groups of products for Marketing and Sales Forces.