Post Market Regulatory Affairs Support
We are specialists in delivering consulting services to provide expertise in post market and life cycle regulatory activities including:
- Licence variations via mutual recognition, decentralised and centralised procedures
- Line extension submissions
- PIL testing
- NTA to CTD conversions
- Regulatory strategy and portfolio analysis to deliver streamlined procedures through grouped variations etc.
We have assembled a regulatory team with broad industry knowledge enabling the company to offer a wide range of outsourced regulatory options to small pharmaceutical companies through to multinationals. Examples of our work include:
- Provided full post market regulatory control of UK national product lines for UK and international generics companies
- Helped a top 50 pharmaceutical company to relocate their operations by providing a full service outsourced regulatory department
- Providing ongoing overflow UK and EU regulatory services to many international pharmaceutical companies
- Gave EU regulatory strategy advice to multiple non-EU organisations
- Carried out international manufacturing site transfers by providing a dedicated outsourced team to a top 10 pharmceutical company.
Regulatory Strategy & Legal Basis
The regulatory strategy is the foundation on which a company builds a path through the regulatory landscape, and is an intrinsic part of the planning for the licensing of medicines. Within any successful regulatory strategy, the potential legal basis for a future market authorisation application will be evaluated against the available procedural routes, commercial objectives and available internal and external data. It is essential that companies and their stakeholders identify the most appropriate legal basis for their product and agree a cohesive regulatory strategy to ensure success in applying for a market authorisation. We guide our clients through this process to meet their commercial needs.
The Brexit process is a significant topic that has the potential to cause a major change to regulatory strategy. We have assembled a Brexit Package of services to help clients to carry out a gap analysis and portfolio review leading to a bespoke Brexit Plan to help identify any necessary actions to ensure their business continuity. We provide an ongoing assessment of the Brexit process in our news section.
Outsourced Regulatory Department
Diamond has been a trusted resource for a variety of companies of all sizes looking to make improvements or changes to their regulatory operations. Our clients have turned to us to provide outsourced solutions to :
- Overcome a significant workload increase
- Place regulatory life cycle management in safe hands whilst internal reorganisations take place
- Keep internal headcount to a minimum in small generics pharmaceutical companies
- Support non-EU pharmaceutical companies entering the EU market
- Increase workflow efficiency.
We specialise in building bespoke regulatory teams to provide a reliable regulatory workflow with appropriately qualified staff available for each task. The outsourced model can be run in either dedicated FTE or task-based contracts. In one case, we were responsible for ensuring that the client’s entire EU product portfolio remained in compliance whilst also growing the product range by preparing and managing new submissions.
Overflow Regulatory Department
The work flow in regulatory groups can undergo periods of extreme pressure as unexpected projects, changes to legislation, or structural reorganisations and potentially Brexit, create a surge in work load. Recruiting skilled staff to meet these demands is not straightforward.
We understand this pressure. Over the years we have provided overflow regulatory department coverage to a range of clients from small virtual generics companies through to top-10 global pharmaceutical companies.
Integrated Services and Pharmaceutical Management Consulting
We can provide management consulting services to pharmaceutical companies entering the EU market by pooling the knowledge of our diverse teams into an integrated service. In one example we provided a global programme management team for a generics pharmaceutical company carrying out the following tasks:
- Assembly of external subject matter experts (Technical CMC Ops, Non-clinical, Clinical)
- Programme gap analysis and regulatory-clinical development plans
- Bespoke programme management platform, data room access and management
- Outsourced CMO/CRO management and integration of independent consultants to provide technical oversight
- Operational management
- Regulatory, Pharmacovigilance and Compliance and Quality leadership
- Dossier writing and MAA submission