Clinical Regulatory Services
Accelerate Clinical Development with DDReg’s Regulatory Expertise. DDReg delivers end-to-end support to streamline the regulatory submission process for clinical trials, enabling sponsors to efficiently meet global compliance requirements. Our regulatory specialists provide strategic guidance and operational execution to navigate complex regulatory landscapes while maintaining strict alignment with international health authority standards and ensuring patient safety.
DISCOVER MORERegulatory Consulting Services for Clinical Trial Management
Clinical trials for pharmaceutical product development often face challenges from an ever-evolving regulatory environment. Sponsors must balance robust data collection with strict adherence to safety and ethical standards. Our team guides you through these challenges by offering expert regulatory consulting that keeps you aligned with the requirements set by global health authorities.
With diverse regulatory frameworks across regions, harmonizing trial protocols, endpoints, and data reporting is critical for multinational studies. Our approach ensures effective communication with regulatory authorities, enabling timely responses to queries and modifications. This service is essential to maintain compliance and minimize delays in your clinical trial regulatory affairs journey.
Clinical Trial Application Submissions
One of the major hurdles for clinical trial sponsors is the submission of applications to healthcare authorities. Each country requires tailored documentation and compliance with its unique regulations. For example, sponsors in the USA must file an Investigational New Drug (IND) application with the FDA, while those in the EU and UK need to submit an Investigational Medical Product Dossier (IMPD).
Insufficient data or misaligned regulatory documents can delay approval, impacting your trial timeline. Challenges include clinical study report writing, translation of documents, and in-country support for submission and liaison. Our team leverages years of experience to integrate these processes efficiently, ensuring that all regulatory documents for clinical trials are meticulously prepared and compliant.
Our Clinical Trial Regulatory Expertise
- Support in clinical study report writing per country-specific regulations
- Strategic advice for clinical trial applications to minimize agency queries
- Due diligence for early-phase clinical protocols and regulatory gap analysis
- Pre–IND meeting support with the US FDA (Type A, B, C, etc.)
- Development and review of key clinical documentation (investigator’s brochure, informed consent forms)
- Authoring, compiling, reviewing, and submitting clinical trial application packages
- E-submission and digital filing of applications
- Timely responses to regulatory queries regarding application submissions
- Translation services for clinical trial documentation
- Post IND/CTA submission regulatory activities
- Support for diversity plans and compliance with racial and ethnic minority requirements
Ready to overcome regulatory challenges and secure fast clinical trial approvals?