Drug Development Regulatory Services
Professional Ora provides specialized, comprehensive Regulatory services that aid drug development from the earliest stages. Our Regulatory services are meticulously designed to provide drug development Regulatory support for various drug candidates (biologics, pharmaceutical products, combination therapies, etc.).
Our Regulatory experts possess extensive experience in dealing with various Regulatory aspects of drug development (non-clinical, clinical, and quality). Our offerings address the unique challenges of each drug development program, ensuring that critical developmental issues are effectively managed. Employing our proactive approach to resolving Regulatory imperatives, we aid in mitigating risks, streamlining processes, and expediting timelines, ultimately bringing your innovative therapies to market faster.
Dossier Services
A well-built CTD dossier provides health authorities (HA) with complete technical and scientific information needed to evaluate the quality, safety, and efficacy of human medicinal drug products. Professional Ora’s dossier authoring expertise supports your product registration efforts by providing comprehensive, HA-compliant documentation and recommendations to meet the HA requirements.
From initial registration to market expansion of the medicinal products, Professional Ora experts ensure that all Regulatory requirements are met to avoid HA rejections, facilitating successful on-time approvals with all necessary support during HA review and maintaining compliance throughout the product lifecycle by authoring the high-quality dossiers that comply with global Regulatory standards and requirements. The experience of Professional Ora’s experts in medicinal product registration ensures that product registrations are complete, Regulatory compliant, and positioned for on-time Regulatory approvals, enabling manufacturers and sponsors to achieve timely approvals and swift market entry.
Our dossier authoring services include:
Response to HA Queries
Submission of Full Applications
End-to-End Product Registration
Biologics Registration Services
Hybrid Application Submissions
CMC-Quality Modules
CTD Templates
Core/Master Dossier
Market Expansions
End-to-End DMF Registration
End-to-End Excipient DMF Submissions
Product Life Cycle Management
Submission of post-approval changes for the approved medicinal drug products is critical to ensuring the compliance of the registrations and managing the lifecycle of the application. Health Authorities (HA) require continuous oversight on any change made/proposed to the registered content of the drug product is submitted and necessary approval is received before implementation as applicable.
At Professional Ora, we offer a range of post-approval and lifecycle management services to ensure that the registered drug products remain compliant and competitive throughout their lifecycle. From change control assessment, change submission strategy, preparation, and submission of a variation package to ensure approval receipt from HA, our experts provide the support needed to navigate the complexities of Regulatory post-approval and lifecycle management.
Professional Ora lifecycle management services are designed to support the registered drug products in managing these post-approval activities effectively.
Our services include:
- Change Control Evaluation and Submission Strategy
- LCM/ Post-Approval Changes Submissions
- Nitrosamine Impurity Risk Assessment Submissions
- Manufacturing Site Registration
Country -Specific Regulatory
Professional Ora provides comprehensive support to ensure that your products meet local Regulatory standards and achieve successful approvals through interactions and follow-ups with HAs on ever-evolving country-specific Regulatory requirements and regular dialogue to clarify the technical content, which helps expedite the review and approval. Our country-specific Regulatory services are designed to help you meet these unique requirements and ensure compliance across all target markets.
Our country-specific Regulatory Services include:
- Legal/Local Representation Services
- Translations Services
- Module 1–Administrative Services
Country-Specific Regulatory Services
- Provision of legal/local representation to comply with local Regulatory requirements
- Ensuring compliance with the regional guidelines for document submission
- Regular updates on Regulatory guidelines
- Prepare or review a complete dossier to meet country-specific requirements