ERA is able to contribute at any stage of product development, from discovery, through process development, non-clinical and clinical aspects, to regulatory approval and beyond. One of our recognised specialities is the design of a regulatory strategy, to cover part or all of the development process. Thus, our services include the following: Regulatory due diligence exercises for in- or out-licensing, interactions with regulatory agencies, such as pre-IND, pre-BLA and scientific advice procedures, clinical trial applications, marketing authorisation applications, including eCTD submissions, post-approval amendments or variations, advice on process development, including validation, input on characterisation and control, consulting on non-clinical and clinical strategy, facility inspections and support for establishment licensing.
Femeda is a UK based company focused on developing a range technically ground breaking medical devices for female urinary incontinence. 698 million women worldwide are affected by incontinence, yet many existing products focus on managing and treating the symptoms of urinary incontinence, rather than the underlying cause.
Femeda is focused on the launch of Pelviva™, a unique patented disposable medical device for the treatment of female incontinence. Pelviva™, uses reactive pulse technology to strengthen weak pelvic floor muscles to prevent leaks and control urge incontinence. Pelviva™ has been shown to clinically improve bladder control in 84% of women after 12 weeks of treatment.
Fusion Antibodies is a CMO that offers a range of services covering all stages of therapeutic and diagnostic antibody development from target discovery to delivery of lead optimized commercial candidates suitable for cGMP scale up.
Fusion provides contract services include...
- Antibody Humanization services
- Antibody Engineering Services
- Antibody sequencing Services
- Protein Expression & Purification Services
- Monoclonal Antibody services BLAST & Standard
- cGMP Services
IAG - Image Analysis Group
IA-Group is a strategic partner to bio-pharmacutical companies. We bring extensive therapeutic knowledge and regulatory expertise in strategic use of clinical imaging to enhance understanding of the mode of action, to increase the efficiency of clinical decisions and to accelerate drug development.
IA’s operations team leverage our global footprint and the next-generation cloud based proprietry platform Dynamika to de-risk trial execution and to ensure data quality and integrity. Our venture arm pioneer unique targeted investment and risk-sharing models to enable our clients to reach the next value inflection point faster. We fuse decades of theraputic insight and agile culture to meet today's speed and high standard of therapeutic innovation.
Strategic pharmaceutical and pre-clinical consulting services. Critical due diligence, rationalisation and evaluation of IP portfolios, academic research and early-stage/preclinical projects - ultimately looking to de-risk and increase commercial attractiveness and licensing potential.
Advising and supporting academic institutions and start-up companies on out-sourcing strategies - looking for cost-effective solutions and accelerating the speed of progression and completion of projects.
Oversight and management of outsourced CMC and preclinical projects.
Undertaking due diligences on behalf of organisations in- and out-licencing development drug candidates.
Exploring innovative business models and opportunities for funding between academia and the out-sourcing network, looking to create collaborative win-win partnerships to progress projects.
Attending conferences and exhibitions on behalf of clients, evaluating new product opportunities and service providers.
Illetrop provides hands-on senior executive support to biotechnology companies. Based in Scotland but operating internationally, Illetrop represents a number of companies from the UK, Asia and mainland Europe.
Intract Pharma Limited is an oral drug delivery licensing and product development company offering a range of proprietary formulation technologies to deliver novel and optimised therapeutics targeted to patient needs. The company is a spin-out of University College London, and is centred around over 15 years of research and innovation from the laboratory of Professor Abdul Basit. Intract's range of formulation technologies includes Phloral™ for colon targeted delivery, and ProRelease™, a versatile microparticulate delivery system.
Isogenica is at the forefront of synthetic biology, pursuing a mission to provide the fastest, most efficient engine for therapeutic antibody discovery. Isogenica is developing LlamdA™ (single domain VHH) and Alexandria™ (human Fab) therapeutic antibodies based on its proprietary fully synthetic antibody libraries and leveraging its CIS Display and Colibra™ technologies to accelerate the discovery and development process.
J A Kemp
We are one of the largest UK and European Patent and Trade Mark Attorney firms, with offices in London, Oxford, Cambridge and Munich.
The breadth and depth of our technical knowledge relevant to patents is outstanding, with over 50 science and technology graduates in the firm including over 30 PhDs. No area of science or technology is outside our scope.
Karma Oncology is a specialist oncology clinical development company headquartered in Scotland with offices in Ireland, Netherlands and USA. We offer a complete range of development services from clinical development planning, protocol design and authoring, strategic country/site selection, regulatory submissions, through to clinical trial execution and reporting.
With Karma, experience makes the difference - Our team has successfully completed programs in a broad range of solid tumour and hematologic indications utilizing an array of different therapeutic approaches including immunotherapy and autologous cell therapy and CAR-T cell therapy.
Karma is flexible - We can provide selected individual services, and extend to full-service global CRO capabilities as the program needs expand. Our size allows us to be flexible, innovative and responsive to individual sponsor requirements and to adhere strictly to specified development timelines.
Karma is different - Our Project Managers have extensive oncology experience, our monitors are professional, mature 'career' CRAs - not trainees - and we have the lowest staff turnover in the industry (<5%). Many of our staff come from a nursing or medical background, and for international studies we use CRAs native to their country.