With Kindeva Drug Delivery, you benefit from highly skilled regulatory support throughout the life cycle of your combination product, backed by decades of experience with global regulations and standards. Whether pre- or postmarketing strategies, our in-house experts help support all your regulatory needs worldwide with knowledge and know-how built from an array of advanced scientific, technical, and regulatory backgrounds, including an extensive understanding of FDA and EMA regulations.
Regulatory services
Our regulatory services are focused on building a successful vendor-client relationship where we are ideally positioned to provide you with comprehensive regulatory strategies and submissions in the most efficient and cost-effective manner possible. These services cover the full spectrum of drug product and drug substance activities, from development to life cycle management.
Our goal is to facilitate high-quality, scientific submissions that result in the required health authority approvals. Kindeva’s regulatory team:
- Consists of former regulators and industry specialists skilled at providing dossier preparation, global regulatory submissions, and strategic regulatory planning for products in all stages of development
- Remains fully up to date with global regulations and guidelines
- Prepares regulatory strategies to support optimal product development that aligns with current best practices
- Closely monitors the regulatory landscape to ensure the latest requirements are well understood and implemented across provided submission data
- Delivers high-quality submissions that meet strict regulatory deadlines with format and messaging accuracy and consistency across all documents
- Manages unforeseen regulatory agency or customer timeline challenges
- Identifies risks and implements mitigation strategies
- Acts as an extension of your internal regulatory affairs team
- Supports all types of submission applications (initial, supplemental, major and minor, etc.)
- Uses a cost-effective, right-the-first-time approach to all submissions and regulatory activities
Kindeva Drug Delivery’s regulatory services include:
We monitor current legislation and guidelines to:
- Efficiently deliver quality regulatory services and submissions
- Enhance regulatory and submission strategies
- Provide sound regulatory advice
We advise our clients of:
- New and existing guidance documents and regulations
- Existing pharmacopeial requirements (e.g., USP, Ph. Eur.)
- Upcoming revisions to pharmacopeial standards
We increase your productivity and efficiency by:
- Providing regulatory expertise as part of your teams
- Collaborating with your teams to ensure transparency and proactive problem solving
- Decreasing time to key decision points
- Mitigating regulatory risks
- Determining optimal regulatory strategies
- Managing all regulatory filings
We provide CMC consulting to support:
- Drug substance (DS) and drug product (DP) formulation, development, and manufacturing
- Validation activities pre- and post-approval
- Gap analysis
- Technology transfers
- Initial DMF filings
- Preparation and submission of INDs, NDAs, ANDAs, MAAs
- DMFs, IMPDs, post-approval submissions
- Assessment of impurities or degradants
Kindeva can serve as your point of contact for regulatory agency interactions. We prepare and submit:
- Responses to health authority information requests
- Advice letters
- General correspondences
- Briefing document packages for health authority meetings
- Supportive documentation for HA meetings
Our regulatory services team collaborates with your organization to understand your needs and develop a strategy to make the most of your time with the health authority. This includes:
- Identifying crucial discussion points
- Preparation of meeting questions and rationale
- Meeting requests and briefing package submissions
- Coaching for face-to-face meetings and teleconferences with the health authority
- Meeting minutes
- Post-meeting follow-up interactions with the health authority
- Interpretation of health authority responses
- Coordination of additional activities as needed
Development of new drugs is a challenging and complex process associated with long timelines. In response to this fact, many health authorities have put regulatory pathways in place to expedite drug development and approval.
If your drug product meets the regulatory requirements of any of the expedited approval pathways (e.g., accelerated approval, accelerated assessment [EU], priority review, fast track, and breakthrough therapy designation), Kindeva can support you with:
- Preparing the expedited approval request applicable to your product
- Submitting the application
- Health authority interactions and meeting planning
- Coaching for the forthcoming close collaboration with the health authority during product development
Kindeva collaborates with you to prepare and review both new labeling pieces and revisions to existing labeling. Services include:
- Reviewing and evaluating labeling for applicable information (e.g., reference listed drug)
- Providing label requirement compliance strategies and recommendations
- Responding to health authority label revision requests
- Preparing all required documentation to support labeling revisions (e.g., justification documents, annotated side-by-side comparisons of proposed and current labeling, redlined documents, artwork, reviewer aids)
- Composing supplemental labeling revision applications
- Ongoing response support for health authority information requests and labeling negotiations
We provide SPL and XML labeling submission services, including:
- Drug product listings
- Preparing SPL submissions for draft labeling submissions
- FPL preparation and submission for approved labeling and annual reportable changes
Kindeva can support you with all your submission dossier preparation needs, including:
- Preparing draft documents for your review
- Facilitating meetings in close coordination with key stakeholders to discuss submission strategies and finalize documents
- Compiling CTD TOC in accordance with ICH M4Q and dosage form specific regulatory guidance
- Ensuring published documents have required internal and external links, table of contents, and bookmarks
Our regulatory services team provides your organization with support for all types of marketing applications (e.g., IND, NDA, ANDA, BLA, CTA/IMPD, MAA). We accomplish this by:
- Assisting with marketing application submission strategy to increase likelihood of successful approvals in multiple markets
- Applying for application numbers
- Preparing intent to submit applications
- Coordinating and strategizing meetings with respective health authorities
- Implementing regulatory project management
- Preparing initial as well as subsequent supplemental/post-approval applications
- Offering comprehensive end-to-end materials review per current industry regulations
Kindeva transmits your eCTD submissions to designated health authorities using an authorized submission portal (i.e., Submission Gateway). In preparation for this, we help you by:
- Planning and assembling dossier documentation
- Publishing submissions in compliance with eCTD guidelines
- Providing eCTD submission-ready files complete with metadata, internal and external links, table of contents, and bookmarks
Ensure your promotional materials are compliant with the help of Kindeva’s experts. We provide:
- Comprehensive end-to-end review of advertising and promotional materials per current industry regulations
- Review of the materials by the Regulatory, Legal, and Marketing Committee
- Preparation and submission of advertising and promotional materials for U.S. and global markets
The Kindeva regulatory team can support your organization with all types of supplemental filings, including:
- Statutory reporting (annual reports, renewals, and PSURs/PADERs)
- Labeling updates
- Defining strategy, positioning, and preparation of CMC revisions
- Module 1 updates
- Regulatory project management (e.g., defining roles and responsibilities, creating submission plans and road maps)
- Waivers (e.g., BA/BE, pediatric)
- NextGen sales reports
Click on each section to learn more:
Regulatory strategy, intelligence, and gap analysis
We monitor current legislation and guidelines to:
- Efficiently deliver quality regulatory services and submissions
- Enhance regulatory and submission strategies
- Provide sound regulatory advice
We advise our clients of:
- New and existing guidance documents and regulations
- Existing pharmacopeial requirements (e.g., USP, Ph. Eur.)
- Upcoming revisions to pharmacopeial standards
We increase your productivity and efficiency by:
- Providing regulatory expertise as part of your teams
- Collaborating with your teams to ensure transparency and proactive problem solving
- Decreasing time to key decision points
- Mitigating regulatory risks
- Determining optimal regulatory strategies
- Managing all regulatory filings
We provide CMC consulting to support:
- Drug substance (DS) and drug product (DP) formulation, development, and manufacturing
- Validation activities pre- and post-approval
- Gap analysis
- Technology transfers
- Initial DMF filings
- Preparation and submission of INDs, NDAs, ANDAs, MAAs
- DMF, IMPD, post-approval submissions
- Assessment of impurities or degradants
Regulatory agency interactions
Kindeva can serve as your point of contact for regulatory agency interactions. We prepare and submit:
- Responses to health authority information requests
- Advice letters
- General correspondences
- Briefing document packages for health authority meetings
- Supportive documentation for HA meetings
Our regulatory services team collaborates with your organization to understand your needs and develop a strategy to make the most of your time with the health authority. This includes:
- Identifying crucial discussion points
- Preparation of meeting questions and rationale
- Meeting requests and briefing package submissions
- Coaching for face-to-face meetings and teleconferences with the health authority
- Meeting minutes
- Post-meeting follow-up interactions with the health authority
- Interpretation of health authority responses
- Coordination of additional activities as needed
Expedited approval pathways
Development of new drugs is a challenging and complex process associated with long timelines. In response to this fact, many health authorities have put regulatory pathways in place to expedite drug development and approval.
If your drug product meets the regulatory requirements of any of the expedited approval pathways (e.g., accelerated approval, accelerated assessment [EU], priority review, fast track, and breakthrough therapy designation), Kindeva can support you with:
- Applying and preparing the expedited approval request applicable to your product
- Preparing the expedited approval request applicable to your product
- Health authority interactions and meeting planning
- Coaching for the forthcoming close collaboration with the health authority during product development
Labeling preparation and review
Kindeva collaborates with you to prepare and review both new labeling pieces and revisions to existing labeling. Services include:
- Reviewing and evaluating labeling for applicable information (e.g., reference listed drug)
- Providing label requirement compliance strategies and recommendations
- Responding to health authority label revision requests
- Preparing all required documentation to support labeling revisions (e.g., justification documents, annotated side-by-side comparisons of proposed and current labeling, redlined documents, artwork, reviewer aids)
- Composing supplemental labeling revision applications
- Ongoing response support for health authority information requests and labeling negotiations
We provide SPL and XML labeling submission services, including:
- Drug product listings
- Drug establishment registration
- Preparing SPL submissions for draft labeling submissions
- FPL preparation and submission for approved labeling and annual reportable changes
Submission dossier preparation
Kindeva can support you with all your submission dossier preparation needs, including:
- Preparing draft documents for your review
- Facilitating meetings in close coordination with key stakeholders to discuss submission strategies and finalize documents
- Compiling CTD TOC in accordance with ICH M4Q and dosage form specific regulatory guidance
- Ensuring published documents have required internal and external links, table of contents, and bookmarks
Investigational and Marketing applications
Our regulatory services team provides your organization with support for all types of marketing applications (e.g., IND, NDA, ANDA, BLA, CTA/IMPD, MAA). We accomplish this by:
- Assisting with marketing application submission strategy to increase likelihood of successful approvals in multiple markets
- Applying for application numbers
- Preparing intent to submit applications
- Coordinating and strategizing meetings with respective health authorities
- Implementing regulatory project management
- Preparing initial as well as subsequent supplemental/post-approval applications
- Offering comprehensive end-to-end materials review per current industry regulation
eCTD publishing
Kindeva transmits your eCTD submissions to designated health authorities using an authorized submission portal (i.e., Submission Gateway). In preparation for this, we help you by:
- Planning and assembling dossier documentation
- Publishing submissions in compliance with eCTD guidelines
- Providing eCTD submission-ready files complete with metadata, internal and external links, table of contents, and bookmarks
Advertising & promotion compliance
Ensure your promotional materials are compliant with the help of Kindeva’s experts. We provide:
- Comprehensive end-to-end review of advertising and promotional materials per current industry regulations
- Review of the materials by the Regulatory, Legal, and Marketing Committee
- Preparation and submission of advertising and promotional materials for U.S. and global markets
Regulatory life cycle management
The Kindeva regulatory team can support your organization with all types of supplemental filings, including:
- Statutory reporting (annual reports, renewals, and PSURs/PADERs)
- Labeling updates
- Defining strategy, positioning, and preparation of CMC revisions
- Module 1 updates
- Regulatory project management (e.g., defining roles and responsibilities, creating submission plans and road maps)
- Waivers (e.g., BA/BE, pediatric)
- NextGen sales reports
Informed solutions from a top global team
Bring regulatory expertise to your program with our partner-based, milestone-driven business model that is customizable to the specific needs of your organization. Kindeva offers informed solutions for operations, strategy, and compliance, bringing the global regulatory framework experience you need to ensure success.
Geographical regulatory experience
- North America (U.S. and Canada)
- Europe and U.K.
- China
- Latin America
Site licensing and materials management
- Controlled substances licensing
- Materials certifications for import/export
Team highlights
- 1st HFA product approval in the USA (Proventil)
- 1st generic combination pMDI product approval in the EU and U.K. (Sirdupla/Aloflute)
- 1st generic combination pMDI product approval in the USA (Breyna™)
Expert guidance for your regulatory pathway
Our leading CDMO is focused squarely on drug-device combination products, offering support from a regulatory team that knows the specific requirements at each stage of your product’s journey.
This in-depth understanding of how regulation for combination products and medical devices is handled also enables an exceptional degree of agility, providing the insight necessary to quickly reevaluate the application of regulations throughout the process.
Successful strategies for your combination products
When you combine forces with Kindeva, you can count on:
- A proven track record of obtaining and maintaining IMPD/IND, DMF, and marketing authorization approvals from worldwide health authorities
- In-depth knowledge of global legislation, regulations, and guidelines for drug development to support the design and execution of optimal product development and regulatory strategies
- A deep bench of regulatory experts with vast technical knowledge and a commercial focus to underpin successful regulatory agency engagement
- A long history of outstanding partnerships and customer collaboration, leading to first-to-market product launches
- Successful coordination with stakeholders in developing/authoring the documentation required to support regulatory submissions
- A wide range of analytical and testing services, conducted in accordance with cGMP standards in an FDA-registered facility