Regulatory Affairs
Navigating regulatory requirements is crucial for the successful development and commercialization of medical products. At Connect Pharma, our Regulatory Affairs services are designed to guide you through every step of the regulatory process, ensuring your products meet all necessary standards and reach the market efficiently.
We assist in developing comprehensive regulatory strategies tailored to your product and target markets. Our strategies are designed to streamline the approval process and ensure compliance with local and international regulations. Our services include:
Market Entry Strategy
Crafting a roadmap for entering new markets, taking into account the specific regulatory landscapes and requirements.
Regulatory Pathway Identification
Identifying the most efficient regulatory pathways for product approval, whether through expedited programs, standard review processes, or other mechanisms.
We prepare and submit high-quality regulatory dossiers, including Common Technical Documents (CTD) and electronic CTD (eCTD). Our team ensures that all documentation meets regulatory standards and guidelines.
Documentation Compilation
Collecting and organizing all necessary documents, data, and information required for dossier submission.
Technical Writing
Crafting clear, concise, and scientifically robust sections of the dossier, including the Quality, Nonclinical, and Clinical modules.
Electronic Submissions
Ensuring all documents are formatted correctly for electronic submission, adhering to the technical requirements of eCTD standards.
We provide ongoing regulatory intelligence to keep you informed about changes in regulatory requirements and trends. Our compliance services include gap analysis, audits, and training to ensure that your operations meet current regulatory standards.
Regulatory Updates
Regularly monitoring and analyzing changes in regulatory policies, guidelines, and legislation that may impact your products.
Compliance Audits
Conducting thorough audits of your processes and documentation to identify gaps and areas for improvement.
Agency Interactions
Managing all communications with regulatory agencies, including submissions, responses to queries, and follow-up actions.Issue Resolution
Addressing any regulatory issues or obstacles that arise, ensuring timely and effective resolution to keep your projects on track.Our services extend beyond product approval to include post-approval maintenance. This includes managing variations, renewals, and lifecycle management to ensure continued compliance and marketability of your products.
Variation Management
Handling all types of variations to approved products, including minor and major changes, and ensuring timely submission and approval.
Renewals
Managing the process of renewing product approvals, ensuring all necessary documentation and data are submitted on time.
Lifecycle Management
Providing ongoing support to maintain the regulatory compliance of your products throughout their lifecycle, including labeling updates, safety reporting, and post-market surveillance.
At Connect Pharma, we are committed to providing comprehensive and expert Regulatory Affairs services to support your medical products from development through post-market maintenance. Our goal is to ensure your products meet regulatory requirements, achieve timely approvals, and maintain compliance throughout their lifecycle.
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