Introduction
BethAri offers a comprehensive range of Regulatory Affairs services. Our expertise is garnered from over 20 years of extensive and broad experience in all aspects of international Regulatory Affairs and as a result is well positioned to provide you with expertise across all major healthcare sectors, including pharmaceutical, biotechnology, consumer healthcare, medical devices and generics. We can provide excellent assistance and guidance for your global needs; including dealing with FDA regulations, EU regulations, or with regulatory agencies across the emerging markets.
Our innovative and customised services can be tailored to meet your requirements in:
- Product Development
- Regulatory Strategies
- Preparation Of Dossiers
- Pharmaceutical Products
- Regulatory Training
Product Development
The Regulatory framework around the development of a medicinal product can sometimes appear to be a complex maze of legislation, especially within the evolving regulatory landscape of the emerging economies. For a cost effective medicinal product development it is imperative to have sound input from experienced and knowledgeable Regulatory Affairs professionals, and consequently ensure that your product will move successfully through Regulatory Agency assessment to approval; and thereafter that lifecycle activities will be performed to ensure both product optimisation and compliance.
Based on our understanding and experience of the legislative framework guiding a diverse regulatory landscape, BethAri Regulatory experts can provide support by -
- Providing Regulatory guidance for the development of your medicinal products (new chemical entities, biotechnology, generic or biosimilar products) across different markets.
- Providing strategic advice in all stages of medicinal product development – from candidate selection, preclinical and clinical – to ensure that Regulatory & legislative requirements are met.
- Managing the timely requests and further requirements of the Regulatory Agencies to ensure timelines for product launch are met.
Regulatory Strategies
In this environment of rapid changes and ever increasing demands, it is imperative that organisations are flexible and adaptive to enable smarter working practices than ever before, especially in the fluid global environment. Regulatory partnership is a major strategy that ensures such medicinal product development organisations focus on their core competencies.
With over 20 years of experience backed by successful track record of timely and extensive approvals, we can help our clients navigate the Regulatory maze with innovative and customized solutions. Our Regulatory Affairs professionals have in-depth knowledge and experience to tailor strategic plans to meet different regulatory requirements, and thereby;
- Evaluate technical data (chemistry/manufacturing, preclinical, clinical), to help determine the appropriate regulatory procedure and legal status for products.
- Assist in the design & development of Regulatory Strategies for successful and efficient approval of products in all both mature and emerging markets.
- Highlight critical issues in all areas of medicinal product development, offering advice on trends and current market needs whilst assisting in providing solutions and mitigation/contingency plans.
- Clarify and highlight the impact of emerging and existing legislation and guidelines for a successful formulation of international bridging strategies.
- Advise on scenarios around life-cycle planning, Regulatory Affairs & Regulatory Operations Outsourcing.
Preparation of Dossiers
The success of regulatory approvals is, in most cases, very dependent upon the quality of the data submitted. A considerable amount of effort is expended towards product development, with the goal of producing a Regulatory dossier for submission to the relevant Agencies. Consequently, preparing a registration submission must not be viewed as an administrative exercise intended simply to assemble the appropriate documents into the format laid down by the relevant guidelines. The compilation and evaluation of a dossier is based on both scientific considerations and administrative aspects such as layout and presentation of the data, taking into account relevant current guidelines. This should ultimately ensure that such a dossier meets the requirements in terms of content, format and quality of presentation.
BethAri Limited can assist with the preparation of all types of dossiers for submission across both the Major & Emerging markets, including;
- Preparation of Registration Dossier for Marketing Authorisations & Variation Applications in CTD and eCTD Format.
- Revision of SPC, PIL & Labelling.
- Management of Regulatory Procedures (Clinical Trial Applications, Product Licensing, and Lifecycle management activities including Variations, Renewals, & Transfers).
- Dossier Adaptation, including CTD conversions, and for new markets.
- Abridged Marketing Authorisation Applications
- Quality Overall Summaries
Regulatory Training
The value of training and continual knowledge update for the Regulatory Affairs professional should not be underestimated. We offer both basic and advanced courses in pharmaceutical, veterinary and medical device Regulatory Affairs for employees new to the profession, administrators and or support staff in Regulatory affairs and other related disciplines such as manufacturing or marketing. Our training course in Regulatory affairs is suitable for both staff in Agencies and Companies.
The training courses can be conducted in small groups with a specified maximum number of participants to allow for a stimulating and practical training environment. Typical course content for our be-spoke training programs cover a wide range of areas within the discipline of Regulatory Affairs including;
- Overview of drug product development including Clinical Trials
- Marketing Authorisation Applications
- Life Cycle Management & Variations
- Dossier Evaluation and in depth assessment of data requirements for the different modules
- Labels and Leaflets