Your strategic partners in growth.
Taking a drug development programme from the lab bench, through clinical development, and finally to the patient, takes years of expertise, effort and expense. At Bionical Emas, we recognize every client’s program presents unique regulatory challenges.
The Bionical Emas team is your ideal strategic, regulatory, consultancy partner. Providing a range of services, from ad-hoc, specific regulatory, technical or therapeutic advice, to comprehensive, full-service provisions.
Preparing for scientific engagement with a health authority or technical assessment body can be a daunting and complex task. The experienced Bionical Emas team support clients every step of the way, providing a regulatory roadmap, that supports their program and strategic plans. The experienced Bioincal Emas team, ensures clients interactions with health authorities or technical assessment bodies are maximised to the full.
In addition to the functional consulting services, Bionical Emas enable clients to maintain strategic control of non-operational services, in order to achieve company goals and objectives in clinical outsourcing in a cost-effective way:
- RFP/Tendering Process: Ensuring our clients maximise the tendering process
- Sponsor Oversight: Acting as an effective representative, where our clients need to engage with larger CROs
- Governance/KPI Risk Management: Providing functional or management oversight whilst optimising operations through KPIs. Identify the associated risks and mitigating provisions
- Project Management Office: Focused on broader process, program or business goals. PMO responsibilities may involve program scope changes to leverage opportunities, optimizing shared best practice to ensure consistent project execution
Your development program may require a course correction or require input on next steps. We can provide timely input via due diligence, at any part of the process.
Scientific advice is the provision of advice to a company by a regional or national Regulatory Authority, on the appropriate tests and studies required in the development of a medicine or on the quality of a medicine. Timely engagement with a relevant authority can increase the probability of a positive outcome for your registration.
The non clinical (or pre-clinical) development phase primarily aims to identify which therapy has the greatest probability of success, assess its safety, and build solid scientific foundations before transition to the clinical development.
The non clinical development of a medicine is complex and regulatory-driven, with each programme requiring a customised approach, suited to support the follow-on clinical program. At Bionical Emas, we can advise on the right approach and ensure your non clinical package meets the immediate and/or long-term needs.
Roadmaps are designed to inform our clients of what they need to know, before business-critical decisions are made. A Roadmap will provide the client with an applicable suite of potential regulatory procedures. We’ll outline the key considerations of each, to enable you to decide which procedures are appropriate for your eventual Submission Strategy.
With a Roadmap in place, or if a client has reasonable idea of a pathway, we can develop a Regulatory Submission Strategy, which can cover national, regional or global markets. The Strategy will give the client a clear perception of data requirements, timings and the sequence of regulatory activities.
Bionical Emas are experienced in all aspects of the Data Management process from Protocol input to Database lock. We can advise sponsors on the technology, processes and procedures required to provide high quality data at the end of the clinical trial.
- Data management process training
- Data management training for non-data Managers
- Data management SOP writing
- Evaluation and implementation of Electronic Data Capture (EDC) tools
- Data management specific audits
We recognize the importance of strategic analysis and decision-making in drug and medical device development, and there are a number of different regulatory pathways to choose from. Our customised solutions are adapted to your product development stage help to successfully and proactively tackle the challenges.
We guide you throughout the complex regulatory landscape and complement your own resources, from product development strategy to market authorization and reimbursement.
At Bionical Emas we know that a large proportion of drug discovery and early phase development are managed by Small to Medium Entities (SMEs). We specialize in bringing our expertise and experience to SMEs, tailored to fit your business priorities from ongoing strategic support to one-off consulting engagements.
We can facilitate your engagement with Agency-associated Innovation Networks, who are uniquely placed to enable drug development, at an appropriate pace and scale; driving the adoption and transition of innovative ideas and technologies to healthcare populations.
Our Early Access Programs provide access to potentially lifesaving treatments for patients who are often in desperate need. For the company developing the treatment, this presents an opportunity to positively impact patient lives but can also present risks that need to be carefully managed throughout the planning and implementation phases. Our team of experts can navigate through the various challenges associated with providing access to investigational treatments, from Phase II to late stage development. This includes global expertise in the complex regulatory EAP landscape and guiding our clients on how an EAP can complement the wider regulatory strategy. In addition, we understand the importance to commercial launch of collecting real world data and generating evidence from EAPs that can support applications to regional regulatory and reimbursement bodies.
Joint input from health technology assessment bodies and health authorities can significantly reduce the lag-time between regulatory and pricing and reimbursement approvals. The Bionical Emas team are expertly placed provide advice and facilitate regulatory and pricing/reimbursement drug approval, including the integration of value-based payer evidence requirements into clinical development programs.
Bionical Emas have a long history of providing global pharmacovigilance services. We can advise on the systems and processes required for a company looking to set up pharmacovigilance, from the initial Phase I study right through to a global post-marketing pharmacovigilance system;
- Global, national or regional regulatory requirements for pharmacovigilance
- Requirements for national and regional Qualified Persons for Pharmacovigilance (QPPVs)
- Provision of companywide pharmacovigilance training
- Assistance with preparing the Pharmacovigilance System Master File (PSMF) prior to Marketing Authorisation Application in the EU
- Guidance on global SOP requirements for pharmacovigilance, including assistance with preparing SOPs
Our Quality Assurance Team’s core capabilities and expertise are in the provision of expert, independent Quality Management System (QMS) and establishing Good Clinical Practice (GCP). Auditing and consulting worldwide, they help our clients fulfil their QA needs and allow complete independence of the activities that take place during clinical development;
- Quality Management Systems / Standard Operating Procedure (SOP) Development
- CAPA Management
- Inspection readiness and support
- Risk management and GxP Audit Programs
- One-off audits (for-cause, directed or routine audits)
- From kick-off meeting to SIV in five days – a severe COVID-19 pneumonia case-study Explore
- Effective Pharmacovigilance & Regulatory EU and Australian Due Diligence, leading to operational and consultative support Explore
- Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy Explore
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