Marketing Authorisation Regulatory Support

The pathway to getting a product onto the market can be a long and frustrating journey, and the challenges continue even after the product is placed on the market. We can help with the challenges of placing your product on the market and maintaining marketing compliance worldwide. 

Our regulatory affairs team understands that you need a partner who thoroughly understands the product and the regulatory process. We will work with you and your team through the product lifecycle. Our high rate of repeat business and long term client relationships reflect our expertise and commitment.

Comprehensive regulatory intelligence system 
The support we offer you is made possible through an international global network of experts.  We are experienced at interpreting regulations and guidelines. By sharing knowledge across projects, we maximise efficiency to offer you high quality solutions. 

Full strategic and operational support
Our regulatory experts will work with your in-house teams, from R&D to manufacturing, labelling, sales or marketing, to help make your goals a reality. Our frequent interactions with national, and regional regulatory agencies provides invaluable insights for your clinical development. 

Risk management experts
Our specialist risk management team support Marketing Authorisation Applications by preparing and updating risk management plans (RMP). The multidisciplinary team consists of safety physicians, medical writers and regulatory. We also interact with other experts as necessary such as epidemiology, pre-clinical/pharmacology, and late phase/outcomes research teams.

The recent update to GvP Module V means that the new EU RMP template became mandatory from 30 September 2017. We offer services to transfer existing RMPs into the new template format.

Post-approval & post-marketing support
Our regulatory affairs team collaborate with medical writers to prepare high quality documents such as PSURs and RMPs. We also offer services to prepare safety evaluations, PRAC requests, and benefit-risk evaluations.

Regulatory experts partnering with you
We can support you with the authoring, publishing and submission of:

  • Marketing Autorisation via National Procedures, Decentralised (DCP) and Mutual Recognition (MRP) Procedures
  • Centralised Procedures
  • New Drug Applications (NDA)
  • Active Substance Master Flies / Drug Master Flies (ASMF / DMF)
  • Paediatric Investigation Plans (PIPs)
  • Paediatric Use Marketing Authorisations (PUMAs)
  • Variations and Renewals
  • PSURs
  • Provision of QPPV services
  • Risk Management Plans (RMP) preparation to support MAA phase, or during the post-marketing phase.

The team also has extensive experience in orphan products and supporting SMEs.