Competencies Product Development
Drug Development
Consultancy
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A well-defined drug-development strategy is based on full regulatory compliance, medical and scientific understanding, along with equitable commercial considerations
For over two decades, we have been a trusted partner to the life science industry in supporting several important drug development programs. We are offering a broad range of strategic services covering entire product life cycle. We focus on partnership with our clients and ensuring the highest scientific quality and compliance in everything we do. We will support you across the cumbersome and challenging path of drug development, especially if you are a smaller emerging biotech company. Our experts know the structure of the big and colorful drug development puzzle, can help you putting together the complete picture or find out and solve the key missing pieces that prevented your program progress at the desired speed and within the planned budget.
Our consultancy team is composed of seasoned professionals coming from various fields. We approach every development program very seriously lining up a multidisciplinary team comprising Medical Experts, Translational Scientists, Regulatory Specialists covering all three aspects CMC, Toxicology, and Clinical, Clinical Pharmacologists, Biostatistician, Biomarker Expert, Clinical Trial Specialist, QA Expert. We create drug development plans in compliance with the most rigorous regulations to deliver the best results for our clients. Feel free to approach us irrespective if you need full, E2E, or just services as per need, or services by specialty areas in drug development.
Structure of Our Drug Development Consultancy Services
CMC and Nonclinical consultancy services
Our multidisciplinary team is available to assist you from the beginning of the product life cycle i.e., from discovery & formulation to the CMC development and the nonclinical toxicology. We provide unparalleled expertise to emerging pharmaceutical and biotech innovators seeking product approvals in major global markets.
Our primary focus is a partnership with our clients and the delivery of the highest scientific quality, without ever losing sight of the big picture and budgetary conditions.
Our dedicated preclinical team is available for consulting, strategic planning, due diligence, regulatory support, technical writing, document compilation, gap analysis in all aspects of preclinical development.
CMC Services
- Support and facilitate the process from idea to a new drug product on market within CMC development
- Pharmaceutical development strategy
- Interim capacity as project manager, CMC coordinator or scientist.
- CMC regulatory support
- Prepare and participate in various formal meetings with the RA, such as Pre-IND meetings, pre-NDA/BLA submission meetings
- Organize the minutes of the meeting, record the opinions and discussion results of the issues in the meeting
- CTD module 3 compilation and
- CTD module 3 gap analysis
- Planning and conducting of CMC due diligence (DD), including reporting and recommendation
- Upstream supply chain planning and implementation
- Downstream supply chain and related distribution licensing & GDP requirements
- Investigators Drug Brochure development
- IMPD compilation, review and gap analysis
- Develop global registration strategies
Non-Clinical Consultancy Services
- Preclinical Strategy/Program Design in field of:
- GLP Toxicology Studies;
- GLP PK Studies;
- Non-GLP Pharmacodynamics Studies
- Protocol and Report for PK/PD/Toxicology (Preparation, Review)
- Nonclinical documentation due diligence for BD transactions
- PK/PD modeling
- Nonclinical study results interpretation
- GAP analysis across CMC, Non-clinical and Clinical program
The clinical phase is the most complex, expensive, and lengthiest period of a medicinal product’s development. In addition, this phase bears the highest risks for the product’s survival. Often, study results are inconclusive, making it tough to decide how to progress forward or stop the entire development program. Sometimes companies advance their programs into more costly next steps based on inconclusive data and consequently incur significant financial losses.
About 70% of the products in phase 1 will move to the next stage, and about 33% will move on to the phase 3 portion (often an extremely costly and protracted phase). Finally, 25 to 30% of these candidate medicinal products will be subject to regulatory submission. Several drug candidates will finally fell at this stage.
We cannot guarantee that your product will succeed. However, we can provide competent advice to mitigate the risks of the inconclusiveness of your study results, contributing with this to investment optimization and timeline improvements. We’ll help you focus right from the beginning on those factors that are critical to ensuring a conclusive outcome of your studies.
- Study design development
- Standard randomized trials
- Seamless study design
- Master Protocols
- Bayesian study design
- Adaptive design
- Umbrella and basket trials
- Outcome measure selection and optimization
- Sample size calculation
- literature search and metanalysis for fine-tuning the assumptions
- Interim sample size calculation, with the development of decision rules and Type 1 error adjustment
- Implementation of the „estimand” terminology in protocols
- Statistical consultancy and analysis optimization
- Statistical section/Statistical Analysis Plan development
- Analysis method selection
- Randomization development
- Randomization code development
- Defining stratification factors
- Design of dynamic allocation plan
- Patients input to protocol
- Informed consent development
- PK/PD modeling
- Nonclinical vs. Clinical gap analysis
Patient Safety Related Consultancy Services
- Medical monitoring strategies
- Medical Monitor outsourcing
- Medical monitoring services in support of ongoing studies
Study Conduct Enforcement
- Project management strategies
- Development of various project management plans
- Project direction
Third Party Vendors Engagement
- Vendor selection and qualification
- Vendor Management plan
- Record management strategies and TMF set up
Bring Your Clinical Trials Into the Future with Decentralized Approaches
The COVID-19 pandemic accelerated adoption of decentralized clinical trials (DCTs), and regulators now endorse thoughtful incorporation of virtual and remote elements to improve trial access, experience, and efficiency. With specialized expertise, Accelsiors helps sponsors harness the power of decentralized trials.
Our approach is tailored and strategic based on the therapeutic area, phase, and specific trial needs. We identify which modular DCT elements—like telemedicine, mobile apps, and remote monitoring—can be implemented to collect high-quality data while enhancing convenience.
With relationships cultivated among global health authorities and experience securing DCT approvals during the pandemic, we smooth the regulatory path for sponsors looking to adopt decentralized trial designs. Real-time access to the latest regional DCT regulations ensures optimized regulatory strategy.
At Accelsiors, we balance innovation with pragmatism. Our hybrid approach integrates on-site and decentralized procedures for a streamlined trial execution. With patient diversity and convenience at the center, we broaden access and represent all populations.
Bring your clinical trials into the future with decentralized elements that deliver data integrity, recruitment gains, and process efficiencies. Let our specialists guide your DCT journey.
Compliance – the key to success in drug development
Let our experienced Quality and Regulatory Affairs experts help you to understand the specific requirements for your drug development program and support you to comply with the US FDA’s, European EMA’s and other applicable international agencies’ directives & regulations, as well as with the applicable GCP and ICH guidelines during each phase of your studies.
Compliance Support
- Plan and revise QMS documents (e.g., policies, SOPs, working instructions etc.)
- Develop, establish and implement quality management system (QMS) in the pharmaceutical and biotech companies
- Pre-inspection and training for Regulatory authority inspection
- GMP and GLP focused audits
- Support in addressing Complete Response Letters
- Support in CAPA development
- Third party Vendor selection and qualification
- Tailored training GxP and related topics (from basic to more advanced workshops)
Specialty Consulting Areas
We are proud for being among the leading CROs in numerous drug development fields and various therapeutic areas across all clinical drug development phases. Allow us to maximize the value of your clinical development program. We will ensure that your study is performed based on the scientific understanding, medical knowledge, regulatory compliance, and experience of our team. Our experts have been supporting many complex drug development programs, but our expertise is special in the following areas:
Specialty Consultancy Areas
- Biosimilar drug development
- Oral formulation optimization
- Support for Advanced therapy medicinal Products (ATMPs) developers:
- GMP and GLP consultancy services
- Submission of ATMP certification request for quality and non-clinical data (Accelsiors has obtained SME status from EMA)
- Preparation of the submission package and submission of request for classification of ATMP
- Close communication and arrangements of meetings with EMA
- Preparation/review of briefing package and submission of scientific advice/protocol assistance
- Generics
- Hybrid generics / 505(b)(2) pathway
- Complex Generics
- Scientific advice and Protocol Assistance
- preparation of a briefing book and the Letter of Intent/Application Forms
- communication and arranging of meetings with EMA and National Competent Authorities
- EMA and FDA Orphan designation
- Preparation of scientific document and submission using IRIS platform
- Pediatric Protocol and Pediatric Investigational Plan
- Preparation of scientific document (part B-F), letter of intent, submission and communication with PDCO
