Services Consultancy in product development
Regulatory Consultancy
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Empowering Drug Development: Streamlined Regulatory Strategies with Accelsiors
Navigating the path to drug approval is a complex journey filled with multiple regulatory challenges. At Accelsiors, we’re here to guide and support you every step of the way. Together, we’ll unlock new opportunities and create value in your drug development and regulatory strategies.
Join Forces with Accelsiors: Your Trusted Regulatory Partner
We don’t just work for you – we work with you. Our team integrates seamlessly into yours, stimulating in-depth scientific discussions, asking probing questions, and providing insightful answers. We harness advanced consultancy approaches and technologies, from modeling and simulating to analyzing similar cases. We aim to fast-track your drug development program, delivering an accelerated return on your investment.
Experience, Excellence, and Success
Our consultancy work is custom-tailored to meet the needs of emerging biotech companies. We have a broad spectrum of expertise, spanning therapeutic areas such as immunology, CNS, endocrine and metabolic diseases, hepatology, gastroenterology, nephrology, orphan diseases, women’s health, pediatric indications, and infectious disease.
We are proud to have played a part in the successful market launch of numerous new drugs. Let us add your success story to our growing list.
Compliance First: Ensuring Global Regulatory Adherence
Our work adheres strictly to the regulations of the FDA, EMA, MHRA, and, when applicable, local regulations. Our meticulous attention to compliance safeguards your interests while reinforcing your credibility with health authorities worldwide.
Specialized Support for Niche Fields
We specialize in niche fields, offering expert support for the application of designations such as orphan, priority review, breakthrough drugs, and Advanced Therapy Medicinal Products (ATMP). With Accelsiors, you can rest assured that you’re getting the most from your drug development journey.
At Accelsiors, our mission is clear: to expedite your journey through the regulatory maze with expert guidance and strategic insight. Let’s join forces and turn potential into successful outcomes.
Regulatory Consultancy SERVICES IN DRUG DEVELOPMENT
Empowering Drug Development with Regulatory Expertise:
Your Goal, Our Priority
At Accelsiors, our seasoned Regulatory Team harnesses a blend of knowledge and experience, capable of supporting clients throughout the intricate journey of drug development. We share your ambitions and work diligently to conquer timelines, all while safeguarding the critical trinity of quality, compliance, and cost-efficiency.
Immerse in a partnership where your regulatory goals are prioritized, and challenges are transformed into achievements. Together, let’s make drug development not just more streamlined, but also more impactful.
Our Regulatory Consultancy services in drug development
Fields of expertise
Health Canada
- Pre-submission or pre-application meetings
- ANDS and NDS
FDA
- Health authority meetings (e.g., Pre-IND, EPO1, EOP2, Pre-NDA/BLA)
- IND/NDA/BLA submissions; 505(b)(1) and 505(b)(2)
- 510k clearance and pre-market approval (PMA) application
- Emergency use authorization
- Pediatric programs (e.g., iPSPs, and PPSR, FDARA meeting (Type F))
- Expedited programs (e.g., Fast track, Breakthrough designation)
EMA
- MAA submissions
- Health authority meetings (e.g., EMA Scientific Advice, Orphan Designation)
- Expedited programs (e.g., PRIME)
- Pediatric programs (PIPs)
- EU MDR/IVDR submissions
Regulatory Consultancy SERVICES IN SUPPORTING CLINICAL TRIALS
Our involvement in Regulatory Consultancy supporting clinical trials
Regulatory Consultancy Beyond Borders: Navigating the Maze of Clinical Trial Regulations with Accelsiors
Embrace a seamless clinical trial journey with our adept regulatory team, committed to facilitating the regulatory management of your study. Whether you seek advice on strategic elements or need comprehensive support throughout your study, we’re here to deliver.
Our presence spans the globe, and our dedicated teams stay updated with evolving country-specific regulatory requirements. The central Accelsiors Regulatory Affairs unit is reinforced by field-based regulatory experts, ensuring adherence to national and international regulations with unwavering quality and consistency.
Our Regulatory Unit’s involvement transcends all phases of a study – from the clinical trial start-up, through study maintenance, to the final submission of a Clinical Study Report. Journey with Accelsiors and experience a clinical trial process that’s not just compliant, but also efficient and tailored to your needs.
Our Regulatory Consultancy services in supporting clinical trials
- Provision of country level regulatory requirements and clinical trial submission strategy
- Development of the Regulatory Management Plan
- Pre-submission meeting organization with local regulatory authorities
- Creation/review of CMC documents:
- Preparation, Review and GAP analysis of the Investigational Medicinal Product Dossier (IMPD)
- Preparation, Review and Approval of IMP Label Text
- Compilation of submission dossiers to Regulatory Authorities and Ethics Committees
HOT TOPICS IN REGULATORY
Empowering Pediatric Clinical Trials:
Accelsiors at the Forefront
Shaping the Future of Pediatric Healthcare. One Trial at a Time.
Pediatric clinical trials are not just about developing medications – they’re about designing a better future for our children. Gone are the days of treating children as miniature adults; it’s time for tailored treatments that cater to their unique needs.
Accelsiors Capabilities:
- Unmatched Experience: Over 21 years of actively transforming pediatric clinical research.
- Global Expertise: Conducting trials across all pediatric age groups worldwide.
- Quality Revolution: Pioneering Quality by Design (QbD) principles, ensuring superior quality at every step.
- Bridging Partnerships: Leading collaborations across public and private sectors for accelerated drug development.
Accelsiors Pediatric Clinical Research Consultancy
“Pioneering Pathways in Pediatric Progress”
Navigating the Pediatric Regulatory World
Pediatric clinical research is paramount to ensuring the safe and effective use of medical treatments in children. Accelsiors Regulatory Group stands at the forefront of this endeavor, committed to optimizing pediatric drug development for clients across the globe.
Key Global Pediatric Incentives & Regulations
- USA: From the best pharmaceuticals for Children Act offering extended patent protection, to the Pediatric Research Equity Act and Priority Review Vouchers, the US ensures comprehensive support for pediatric drug research.
- EU: The EU Paediatric Regulation ensures meticulous planning and rewards for pediatric-focused therapies. Additional protections and focused pediatric clinical trial networks amplify Europe’s dedication.
- Japan: Emphasizing early consultation and a slew of incentives including priority review and consultation and market protection extensions, Japan champions pediatric research.
- Other Regions: From Canada to India, global players incentivize and prioritize pediatric medicine, highlighting its universal importance.
Harmonizing Pediatric Research Globally
With diverse regulations worldwide, there’s a pressing need for streamlined processes. The International Council for Harmonization leads the way, advocating for unified guidelines and reciprocated recognition of pediatric data across nations.
Why Choose Accelsiors?
- Global Expertise: Our regulatory team boasts extensive knowledge in pediatric incentives and regulations worldwide.
- Strategic Guidance: We combine ethical imperatives with business incentives to chart the best path forward in pediatric drug development.
- Established Relationships: Our strong ties with major health authorities ensure smooth liaisons and optimal results.
- Full-Service Approach: From pre-clinical phases to post-approval, we’re with you every step of the way.
Ready to revolutionize pediatric clinical research?
Let Accelsiors guide you to achieve global success.
Contact us, to discuss your pediatric drug development needs.
Advancing the Future of Pediatric Health
HOT TOPICS IN REGULATORY
Regulatory environment and clinical-trial legislation in EEA
All clinical trials for human medicines in the European Economic Area must be carried out in accordance with Clinical Trial Regulation 536/2014, which came into force on 31st January 2022. The new Clinical Trial Regulation allows for the speeding up of the process for authorizing new clinical trials in EU and reduce the administrative burden associated with the conduct of these studies. Assessment and supervision processes for clinical trials throughout the EU are harmonized via a Clinical Trials Information System (CTIS). CTIS contains the centralized EU portal and database for clinical trials foreseen by the Regulation. The European Medicines Agency (EMA) is responsible for the set up and maintenance of CTIS, in collaboration with the Member States and the European Commission.
The regulation requires a more comprehensive set of application information. An application consisting of Part I and Part II will be created centrally via the new CT Portal. Part I consists of information related to the trial, product and protocol whereas Part II consists of data specific to the member states where the trial will be run. Applications are assessed by the appropriate regulators from individual member states and based on strict timelines as defined in the regulation. The assessment of Part I is carried out by the Reporting Member State (RMS) with the support of other member States Concerned (MSC) and the assessment of Part II is carried out by the MSC.
In case submission of part I and part II for all countries is done on the same day (full initial clinical trial application), approval timelines for all involved EU MS are 106 days (including potential validation questions and Request for Information/Responses). With this approach start-up timelines for EU MS will be substantially minimized.
The new CTR aims not only to attract sponsors to run clinical trials in the EU region but also to foster a patient centric and innovative environment. It will encourage increased transparency throughout the entire process – from application submission to market authorization. The regulation strongly promotes transparency of trial data with it being publicly accessible by default with some exceptions (protection of personal data, protection of commercially confidential information, protection of confidential communication between Member States in relation to the preparation of the assessment report and supervision of the conduct of a clinical trial).
Accelsiors CRO is fully prepared for this unprecedented change in EU regulation and for submitting clinical trials through CTIS. Accelsiors CTR Readiness Working Group has been created in December 2021 and all relevant Accelsiors units (regulatory, medical writers, project managers, QA department, legal, clinical) were trained on EMA training Modules. Accelsiors is among the very first CROs that gained experience in submission via CTIS and have currently several submissions approved.
