Regulinx has experience of a wide range of drug formulations and product characteristics, so that we can provide support to your drug development and formulation issues. Where a particular expertise might be required, we will put you in contact with a member of our wider network, in order to achieve your goals.
The means to get your product approved for marketing and the timings around regulatory submissions, variations and approvals are critical. Regulinx has achieved approvals and negotiated stratagies with EU agencies in timely and efficient ways and can give you the extra ability to get resolution of difficult situations. This can be accomplished as an extra resource or by working alongside in-house staff, achieving the results you need without taking up senior management time.
As PIPs are an intregral part of New Chemical Entity submissions or their line extensions and can arise from some variations, Regulinx has the experience to assist you with constructing the documentation to achieve the best and most realistic outcome. This includes formulation requirements, clinical trial options and setting timelines against development objectives and patient populations.
For products manufactured outside of the EU, Regulinx has set up efficient client import, batch testing and release operations using contract facilities across Europe. This is used as a prelude to obtaining a manufacturer’s licence by the client. Regulinx has close collaborations with QPs who cover a wide range of product types and volumes. Let us discuss this option: submissions can proceed while a European organisation is established, reducing costs and business overheads at a critical time for small companies. With a potential to shorten the time to launch, patients could benefit from new treatments earlier.
Regulinx can support you in a range of due diligence activities from product acquisition to contract facilities. Outcome reports will provide the data you need to make the right decision in these situations.
Regulinx works with independent specialist and expert PV QPs. This is an introductory service to provide a full solution to SME’s and remove the uncertainty of approaching unknown organisations and companies. Once the introduction is made, Regulinx will not stay as an intermediary between you, as that is neither efficient nor cost effective.
Introducing a product into the market invovles integrating many functions to achieve a successful launch. Getting the target Marketing Authorisation and label is critical to the Company and product profile, alongside engagement with key opinion leaders and the right pricing policy. This should be a process which runs throughout the development. The regulatory team at Regulinx has been integral to the launch of NCEs as well as day 1 sales of generic products and can lead the co-ordination of the launch team or assist by suggesting potential strategies to position your product in the target markets. As a further service, our experienced graphics studion can design and produce marketing materials.
Regulinx specialises in supporting SMEs prior to the establishment of a full function organisation: setting up an EU based subsidiary for a non-EU company (to act as the EU applicant), obtaining scientific advice, creating a contract EU batch import, testing and release pathway, API certification, artwork design and mock-ups, readability testing and obtaining a wholesale dealer licence (including appropriate SOPs and warehouse facilities).