IND/NDA/BLA Application Strategy Services
The process of applying for IND/NDA/BLA is crucial in the development of a drug; therefore, a comprehensive plan is required to increase the chances of success. Protheragen offers a number of solutions to assist customers throughout this very complicated procedure, which includes strategic development, document preparation, process supervision, and post-marketing maintenance.
Overview of IND/NDA/BLA Application Strategy
The process of drug discovery and approval is a multifaceted highly supervised endeavour in the context of the pharmaceutical sector. Three key applications are: The IND application, the New Drug Application (NDA), and the Biologics License Application (BLA). Each of these documents is distinct and aims at a specific stage of the market transaction; moreover, they are strategic tools for managing the entire regulatory aspect of the project and easing the application and marketing phases.
IND Application Strategy
Considered as the first step of the clinical development of a new drug, the IND application serves the purpose of drug approval, once it is sanctioned by the regulatory authorities. An IND application strategy is designed taking the following factors into consideration:
- Preclinical Data: Complete details and information obtained from animal studies carried out to study the safety and efficacy of the drug.
- Manufacturing Information: Information regarding the composition of the drug, formulation, manufacturing and quality control
- Clinical Trial Protocols: Proposed plans for the design and conduct of clinical trials which include selection of the subject, administration of dose and definition of the endpoints.
- Safety Monitoring Plans: Procedures for monitoring and reporting adverse events during the course of clinical trials.
NDA Application Strategy
The NDA is filed to acquire permission for releasing a new drug in the US market. The contents of NDA application strategy comprise of:
- Clinical Data: Data obtained during the Phase I, II, and III clinical trials in the drug assessing the safety and the effectiveness of the drug.
- CMC Data: Comprehensive data regarding the chemistry, manufacturing and the controls pertaining to the drug.
- Labelling and Packaging: Contains the labelling and packaging proposed by the applicant with regard to the drug.
- Post-Marketing Commitments: Strategies for drug post-approval vigilance and further investigations.
BLA Application Strategy
The BLA is employed for biological products and here too, the main objective is to secure marketing approval which is centred around the same ideology as the NDA. A BLA application strategy consists of:
- Product Characterisation: An exhaustive product characterisation of the biological product with respect to its structure, function and the manner in which it is manufactured.
- Clinical Data: Analysis and results of the clinical trials which prove that the biological product is safe and possesses purity as well as potency.
- Quality Control: Control measures that were adopted which could aid in maintaining consistency and stability of the product.
- Facility Inspection: Inspection of manufacturing facilities prior to approval to ensure adherence to the Good Manufacturing Practices (GMP).
Our Services
Protheragen offers an all-inclusive service for IND/NDA/BLA application submission with a personalized approach as the team of professionals possesses the required understanding of the process and its complexities.
IND Application Strategy Services
- Regulatory Strategy Development
- Preclinical and Clinical Study Design
- Documentation and Submission Management
- Ongoing IND Management
NDA Application Strategy Services
- Regulatory Pathway Optimization
- Global Regulatory Alignment
- Data Integration and Analysis
- Post-Marketing Planning
BLA Application Strategy Services
- Biological Product Characterization
- Global Regulatory Coordination
- Clinical Data Presentation
- Facility and Process Validation
Our Capabilities
- Regulatory Writing and Editing
The versatility our team possesses can be evidenced by the various degrees ranging from PhDs, MDs, and even scientists, all of whom collaborate to enhance the comprehensiveness of all the regulatory documents required. Our performance is aimed at following regulated standards whilst ensuring that all submissions are made in a timely manner while simultaneously reducing the amount of comments from reviewers.
- Regulatory Intelligence and Strategy
We anticipate the changes in regulatory frameworks and customize our submission strategy accordingly. With the help of our regulatory intelligence services, clients are able to see and prepare for changes in regulatory requirements.
- Gap Assessments and Risk Mitigation
Starting with the clinical development step and progressing further, our specialists carry out comprehensive gap analyses in cooperation with you, as well as create adequate risk response plans and regulatory strategies. Foresight and prevention of possible challenges quite often turn out to be beneficial in addressing significant problems.
- E-Submission Expertise
Protheragen possess proficiency in electronic submission processes and guarantee that all submissions comply with the technical requirements of the regulatory authorities. In addition, our proficiency in e-submission ensures that a seamless review process is achieved and the chances of there being any technical complications and hence any delays, are minimized.
With its vast industry experience and profound regulatory knowledge, Protheragen provides a total span of IND/NDA/BLA applications, which seems to be reasonably designed to meet the particular needs of the pharmaceutical and medical research industry. If you are interested in our services, please feel free to contact us.
