Fast-tracking generic submissions

Are you in need of a combined generic drug bioequivalence testing and submission service? In the fast-paced world of registering generic products, time is of the essence for running the bioequivalence (BE) study, performing the bioanalysis, and writing the marketing authorisation application dossier (eCTD).  Our specialized clinical trial unit, provided by Clinical Trial Consultants AB,… Fortsätt läsa Fast-tracking generic submissions

IRIS roll-out for life-cycle management

Are you ready for the IRIS roll-out for Product Lifecycle Management Procedures? IRIS will become the new submission management system and communication portal at EMA. The first roll-out is live since 23 January 2024, including submission management of variations, Art.61(3) notifications and MAH transfers for a subset of centrally authorised products. EMA will no longer use… Fortsätt läsa IRIS roll-out for life-cycle management

Let’s finish your UFOs

Any UFOs (=UnFinished Objects) on your desktop? Such as regulatory reports and summaries that you never seem to have time for. Consider our regulatory/medical writing services. Let’s finish your UFOs More NEWS & POSTS

Veterinary product information v.9

Have you updated your veterinary product information to QRD v. 9 yet? The EU Veterinary Medicinal Products Regulation (2019/6) entered into force on January 28, 2022, replacing the former directive. The regulation introduced a new version of the QRD template, requiring structural updates to the SmPC, package leaflets and labelling. All existing veterinary products will… Fortsätt läsa Veterinary product information v.9

Struggling with IRIS?

Are you struggling with IRIS and other regulatory systems? At RegFile we regularly make scientific and regulatory submissions via IRIS. We can guide and support you through all steps needed for your submission to reach the agency in good shape. We also offer support with the compilation of background materials, enhanced by subject matter experts… Fortsätt läsa Struggling with IRIS?

Scientific advice in Europe – where to go?

Both national and central scientific advice are important mechanisms to gain feedback from competent authorities during drug development. Your choice of adviser is highly dependent on your type of product, the stage of development, your budget and how much time you have at disposal. Today we are sharing a shortlist that might be helpful when… Fortsätt läsa Scientific advice in Europe – where to go?

”This medicine is great!”

Why can’t I just say that? Pharmaceuticals aren´t chocolate and when it comes to its promotion, ethics is key.The pharma industry has a set of ethical rules, complementing the national legislation on marketing. The rules cover a range of areas such as promotional materials, interaction with health care professionals, patient organisation collaboration, transfer of value… Fortsätt läsa ”This medicine is great!”

Orphan drug designation

To achieve orphan designation, it takes more than just proving your drug is intended to treat a rare disease. Besides prevalence data, in EU you will need to show potential for a significant benefit compared to any existing treatments including non-pharmacological methods such as surgery. So US ODD may be the first step. Together with… Fortsätt läsa Orphan drug designation

Need help with your Investigator’s Brochure?

Do you have all your data but no one to put it in writing in time for submission? A medical writer may be just what you need! Give us call.   #regfile #medicalwriting #investigatorsbrochure #ib /*! elementor – v3.12.2 – 23-04-2023 */ .elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=”.svg”]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}

eCTD publishing

CTD (Common Technical Document) describes the organisation of the regulatory documents supporting the authorisation of medicinal products.     The eCTD (electronic CTD) is a harmonised technical solution to implementing the CTD electronically. It consists of PDF documents, arranged in a set structure with defined folder and document names. eCTD is to be used when… Fortsätt läsa eCTD publishing