Services
How can we help you?
We offer high-quality, cost-effective solutions to enable your innovative products to advance quickly and efficiently to the next clinical milestone, through the delivery of well-planned and proactive operational management and regulatory support. We can support you throughout European Medicines Agency (EMA) or Food and Drug Administration (FDA) regulatory processes.
- Nonclinical and CMC development strategy
- Operational project management of nonclinical/CMC tasks
- Regulatory strategy, scientific advice/pre-IND and CTA/IND/BLA/NDA preparation
- Quality assurance audits
- Clinical trial oversight support
Nonclinical and CMC strategy development
We will guide you through all nonclinical and CMC aspects of development strategy and plan design. Our reverse planning approach ensures that your programme is optimised and tailored to your clinical development, regulatory and company objectives.
Our services include:
- Defining target product profiles (TPPs)
- Establishing an optimised regulatory strategy covering all nonclinical aspects of development (CMC, pharmacology, pharmacokinetics and toxicology)
- Defining customised, regulatory-compliant nonclinical and CMC development plans, complete with timelines, budget estimates and risk assessments
- Gap-fill analysis of CMC and nonclinical data packages and existing development plans
Operational project management
We provide a professional and flexible operational project team to efficiently implement your development plan. We help select the best service providers and manage and coordinate their activities to ensure timely delivery.
Our services include:
- Identifying appropriate contract research organisations (CROs) and contract development and manufacturing organisations (CDMOs)
- Preparing and submitting detailed requests for proposals
- Qualifying CROs/CDMOs through quality audits
- Protocol/work plan design
- Continuous monitoring and coordination of CROs/CDMOs
- Editing study reports and reviewing documentation to ensure regulatory compliance
- Regular reporting to your management or to your board of directors
Regulatory affairs - strategy & submissions
We will support you in your interactions with regulatory agencies and will write key regulatory documents for your applications:
- Briefing book/package for pre-IND and scientific advice meetings with USA & European authorities, respectively
- Investigator’s brochure (IB)
- Investigational medicinal product dossier (IMPD)
- Investigational new drug application (IND)
- Orphan drug designation (ODD) application (EMA or FDA)
- Common technical document (CTD) sections for registration applications
And can help you prepare:
- Patient information leaflets
- Informed consent forms
- Pharmacy manuals
- Paediatric investigation plans (PIP)
We will also:
- Generate presentations and participate in meetings with national competent authorities (EMA and FDA))
- Formulate responses to regulatory agencies’ requests
- Obtain EMA/FDA product classification (such as ATMP classification)
Quality assurance
We will perform quality audits of your service providers, including:
- Preparation of the audit, according to the relevant good manufacturing, laboratory or clinical practice (GXP) and International Organisation for Standardisation (ISO) quality standards)
- Onsite audit of the CDMOs/CROs
- Generation of an audit report
- Follow-up with the CDMOs/CROs to agree on a corrective action plan to address audit findings
We also offer:
- Development, implementation and maintenance of internal quality assurance systems (IQAS)
- Auditing of IQAS
- Quality assurance (QA) training
Clinical trial oversight support
Our clinical oversight support ensures successful implementation and completion of your clinical trial:
- Defining a sponsor oversight plan, including division of responsibilities, and supporting its implementation
- Ensuring clinical quality management system (QMS) and good clinical practice (GCP) compliance through onsite audits of clinical vendors
- Operational management and coordination of clinical vendors, CROs, collaborators and consultants
- Regular progress reporting to your management or your board of directors
- Reviewing, identifying and mitigating trial-related risks
We can also help you:
- Identify relevant clinical vendors
- Prepare and submit detailed requests for proposals
