PLG provides development and regulatory strategy for your promising compound

Do you have a promising compound ready for development and want a smooth regulatory pathway to bring it to the market? We ensure sound strategy, solid studies, a steady dossier, and swift approval. 

We discuss developmental and regulatory possibilities with you and present the results in a regulatory strategy plan. Discussions and interaction are essential, so we support when and how to approach health authorities. 

Your drug or drug-device combination is promising, technologically innovative, and intended for a specific population. Because it’s unique, it deserves an intelligent approach. We explore opportunities in regulations and guidance and alternative marketing authorization pathways for you. 

Not only do we provide you with strategic advice, but we also execute the plan. We prepare all documentation, including meeting packages, clinical trial applications (IMPDs) via CTIS, INDs, target product profiles, requests for specific procedures, and worldwide application dossiers (EU, US, MOW). When needed, we help to select and manage CROs. Lastly, we run the regulatory procedures with – or for – you. 

Our services cover all regulatory requirements up to submission

  • All relevant aspects in a sound regulatory strategy: we integrate development plans, regulatory intelligence, and health authority requirements into a sound strategy, ensuring that requirements in the complex regulatory framework will be met. That includes scientific advice, ODD, PIP, (pre)-clinical development plans, and more.
  • All regulatory and scientific interactions with health authorities: We support you with all regulatory health authority meetings (scientific advice, pre-IND, EOP, pre-submission), whether they are of a scientific or regulatory nature, with a national or a central agency.
  • Medical writing and multi-format publishing for submission readiness: which document must you file: (e)CTA? eIND? IMPD? eCTD for new NDA/BLA/MAA? We make sure you are submission-ready! We write (protocols, IMPDs, clinical study applications, CSRs, Modules 1-5), review, hyperlink, QC, compile, and submit in line with regulatory guidelines. 

Discover more about our services here. 

We can also support your development plans:

We can select CROs for you, check study and experimental protocols, and even help design the non-clinical and clinical studies. Obviously, we also review and/or write study reports. Moreover, we can manage the projects for you. 

  • We can prepare Product Information, including labeling and packaging artwork, TPP, SPC, CCDS, and PIL (Patient Information Leaflet). Our efficient labeling experts with writing and organizational skills will help you to turn your target product profile into compliant product information ready for submission.
  • PLG offers you an integrated approach ensuring quality, compliance, and efficiency. We free up your time and workload by offering strategic advice, project management, and hands-on support while ensuring the highest quality, regulatory compliance, and efficiency. Our help will allow you to provide optimal patient care as swiftly as possible.: 

 

Discover more about our CMC and quality, non-clinical and toxicology, and clinical studies services. 

Allow PLG’s experience to work to your advantage.

The right people in the right place 

The PLG team comprises dedicated consultants with experience in many therapeutic areas, many types and classes of drugs and devices, and a wide range of procedures and applications. 

We can ensure the best match with each consultant having a unique mix of scientific background, regulatory skills, subject matter expertise, and required competencies. 

We are passionate about our job, bringing enthusiasm and dedication to professional excellence. 

Case Study: Broad coverage and a global approach can lead to a smooth development and approval

Client profile:  

Small-to-medium size enterprise based in Germany working in the therapeutic area of oncology. The company was developing a new chemical entity (NCE) to cover the European and US markets.  

Challenges:  

The client requested initial support for the NCE for scientific advice (SA) with national authorities and orphan drug and pediatric development. 

A subsequent request concerned developing product information (PI) for the EU and the US, incorporating outcomes of internal discussions, new data, and responses to EMA (European Medicines Agency) questions during a centralized procedure (CP) and from the FDA in preparation for NDA submission. 

Solution and Benefits:  

We provided SA meeting request documentation and briefing books and prepared Orphan Drug Designations and Pediatric Investigational Plans for the EU and US. This enabled the client to align and accelerate development for both regions. 

Subsequently, we led the multi-discipline labeling team and ensured the drafting, updating, and revising of the production information during the CP. Along the way, we drafted D120 and D180 responses, updated eCTD modules (quality overall summary, non-clinical and clinical overviews, and summaries), wrote justifications for clarification meetings, and checked PI translations. For the US, we provided USPI (including an annotated version) and patient information for the stand-alone and co-packaged product. This involved incorporating internal discussions, making additional clinical data available, and determining the outcome of FDA pre-NDA and Day 70 meetings/advice. Our support has contributed substantially to the product’s market approval in the EU.  

Our experts covered different developmental stages and the US and the EU markets, resulting in a “one-stop shop” for the client. This allowed for continuity harmonization among the data and the ultimate PIs for both regions and provided a cost-effective and timely solution for the client. 

Case Study: Covering device and drug aspects allows for an integrated and efficient approach to bringing drug-device combinations to the market.

Client profile:  

A start-up company based in the EU, developing a drug-device combination. The company aims for a multi-purpose approach by repurposing an alternative formulation and administration pathway.  

Challenges:  

The client requires support for regulatory and clinical strategic advice and hands-on support for clinical trial applications and investigational new drug applications. In addition, medical writing of clinical reports and evaluation of device-related documentation is requested. 

Solution and Benefits:  

We provided the regulatory strategy and clinical development plan and led discussions. We have prepared, submitted, and led scientific advice with national EU countries, EMA, and type B meetings with the FDA. This has resulted in successful meetings and advice, allowing the company to efficiently direct resources to appropriate clinical trials and present its case to external parties, leading to substantial investment. We have delivered CTR-compliant investigational medicinal product (IMP) dossiers and investigator’s brochure, MDR-compliant investigational medical device IMD) dossiers, and risk management file, resulting in successful CTA submissions and approvals via the CTIS system. With three clinical study reports already produced and PLG remaining highly involved in further development, preparations for the eCTD for global marketing authorization applications have started.