|Public / Private
|390 Amwell Road Suite 507 Hillsborough NJ 08844 USA
|Dr Peter Kennerley MB ChB, DA (UK), FFPM CEO
In November 2016 Emas Pharma became part of Bionical, bringing full service Clinical Research services to the Bionical group of companies.
Bionical has a strong clinical heritage and has grown rapidly over recent years through organic growth and the acquisition of complementary businesses that share similar visions and values.
Bionical offers end-to-end solutions to product development and commercialization.
- AE database entry and tracking
- ICSR / SUSAR reporting
- Literature review
- Aggregate report (DSUR / PSUR) preparation and submission
- PSMF preparation
- EU QPPV
- EudraVigilance and XEVMPD registration
- Signal detection
- Review of regulatory documents e.g. RMP, CCDS, IB, Protocol etc.
- Protocol Development
- Global Clinical Trial Authorisation (CTA) submissions
- FDA IND submissions
- Global EC/IRB submissions
- Management of regulatory and ethics approvals (including annual updates, end of trial notifications)
- Legal Representative services (EU & ROW)
- IP Management (formulation, import licence, depot management)
- Global clinical project management
- Study feasibility
- Study site selection and qualification
- Clinical monitoring using a global network of experienced CRAs
- Phase I unit monitoring and management
- Risk based & remote monitoring
- Support and management of investigator led studies
- Trial Master File management (including eTMF)
- Data Management (including EDC provision)
- Global CTAs (ie. EU CTAs, INDs, Australian CTNs etc)
- Marketing Applications (MAAs, NDAs, ,BLAs)
- Orphan Drug Development
- Paediatric planning including waivers
- Regulatory strategic advice including accessing Agency development support (eg Scientific meetings with regulatory Agencies) and early access schemes for products addressing an unmet medical need (e.g. EU PRIME, Innovation Task Force, Adaptive Pathways etc)
- Health economic value propositions
- Regulatory maintenance including label extensions and lifecycle support
- Pre-approval access programs including compassionate use programs, Named Patient Programs and Early Access to Medicines Schemes
- Medical devices development
- Micro, Small, medium-sized Enterprise (SME) qualification
- GxP inspection support
- Other service: Novel food, and Cosmetic development
Medical and scientific service:
- Medical monitoring support- 24×7 hrs.
- Medical review of ICSRs, along with review of regulatory documents
- Medical/Scientific review of promotional and educational material including medical final sign-off
- Advice on ABPI/ European Code Compliance
- ABPI complaint support and handling
- Medical Information Services
- Maintenance of knowledge base/literature review
- SOP/WIs preparation
- ABPI Code advice/training
- Broad therapy area knowledge/expertise
- QMS Development
- SOP Development
- Gap Analysis
- Inspection Readiness and Support
- Audits: Internal, Investigator Site and Vendor
Emas Pharma was established in 1998, initially to enable US biotech and pharma companies to develop medicinal products and medical devices in Europe. From these beginnings, the company derived its original name: European Medical Advisory Services (EMAS).
Following the success of our European operations, the company expandeded its services worldwide and its global and regional operations are now named Emas Pharma.
Emas Pharma team of dedicated pharmacovigilance professionals covers all pre- and post-approval pharmacovigilance requirements from case processing, global regulatory reporting and aggregate report preparation to full service clinical trial or post-approval systems including signal detection, literature review and QPPV provision. Whether it’s for short term-projects such as preparation of a periodic safety update report (PSUR), through to long-term projects such as establishment and operation of a Pharmacovigilance system we have experts on hand to support you. Our experience extends from oncology to endocrinology and from medical devices to CNS therapies. In addition to our dedicated Case Management Team you will also be assigned to one of our experienced pharmacovigilance Project Managers.
Our clients range from virtual biotech companies though small pharma to some of the world’s largest healthcare companies. Our in-house safety database, PV Works, is highly cost effective for clients with small case numbers. Alternatively, our Case Management Team have experience in a variety of safety databases including all the major commercially available global safety databases. With remote access, we can work within your systems entering data directly into your safety database.
We understand that pharmacovigilance regulations are complex and constantly evolving and will ensure that you are fully compliant with all requirements. We pride ourselves on providing a personal service to our clients. We support our clients every step of the way.
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|March 17, 2023
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