Do you have an innovative product? Are you a Small or Medium Enterprise needing assistance to fully capitalise your product’s potential?
The pressure on companies to raise capital and fully maximise the potential of new drug candidates is ever growing. The cost of development is ever rising and the battleground for finance is becoming increasingly competitive. With pressure from all nations to reduce healthcare budgets, it has never been more important for companies to keep costs to a minimum and maximise value of their new products.
Regulatory Agency Initiatives
Regulatory agencies are increasingly looking to support the development of innovative medicines and have established schemes to do so. The agencies are promoting that companies seek to liaise with them as early as possible in the development programme ensuring that neither time or money are wasted during the development of potential new drugs.
Whether you are still at the bench progressing towards your first clinical trial or have already begun your clinical development programme Real Regulatory can support you in maximising the potential of your product enabling you to progress its development to your full capabilities.
We can assist you with the development and writing of documentation essential to the compilation of a Clinical Trial Application and progression towards agency approval to conduct a clinical trial, including the Investigational Medicinal Product Dossier (non-clinical, clinical, CMC and benefit/risk sections), Investigator Brochure and study Protocol.
We can advise and assist you with regulatory agency interactions enabling you to avail of the regulatory agency initiatives which have been established to support drug development.
We can support you across a range of agency interactions including:
- SME classification with the EMA allowing any company granted such status to avail of incentives offered to SMEs by the EMA
- scientific advice meetings to discuss your proposed development programmes across all aspects
- early interaction with national agencies and the EMA to participate in schemes to facilitate early access to new medicines, such as the Early Access to Medicines Scheme conducted by the MHRA or the Priority Medicines (PRIME) scheme conducted by the EMA
- orphan medicinal product designation applications. Increasingly additional sources of funding and grants are being made available by organisations to products with orphan designation
Real Regulatory are ideally positioned to provide specialist expertise supplemented with the support from our panel of product development experts, to aid you in maximising the potential of your product.See our Frequently Asked Questions (FAQs)