Veterinary Medicine Solutions

Regulatory Affairs Services for Veterinary Medicines

Our team of experts possesses in-depth knowledge of FDA CVM and EMA veterinary regulations and guidelines allowing for a globally harmonized approach to development including for those drugs under conditional approval processes. We guide you through the entire regulatory process, offering strategic insights to facilitate product registration and compliance assessments.

Comprehensive Regulatory and CMC Core Competencies:

• Writing, Publishing, and/or Reviewing Electronic Submissions: We assist in preparing, publishing, and reviewing electronic submissions, ensuring accuracy and compliance with regulatory standards.
• Formal & Informal CMC Correspondence with CVM: We handle formal and informal Chemistry, Manufacturing, and Controls (CMC) correspondence with the Division of Manufacturing Technology at the Center for Veterinary Medicine (CVM), ensuring clear communication and compliance with regulatory requirements.
• Question-based Review (QbR) (eCTD Module 2): Our experts excel in Question-based Review, a critical aspect of the electronic Common Technical Document (eCTD) Module 2, ensuring a thorough and compliant submission.
• CMC Technical Section (eCTD Module 3): We specialize in preparing the CMC Technical Section for eCTD Module 3, providing comprehensive information on drug manufacturing processes and controls.
• CMC Protocol & Report Review: DSI conducts meticulous reviews of CMC protocols and reports, ensuring accuracy and adherence to regulatory guidelines.
• Pre-Approval CMC Submission: We handle pre-approval CMC submissions, including Investigational New Animal Drug (INAD) through New Animal Drug Application (NADA) and Generic INAD (JINAD) submissions through Abbreviated New Animal Drug Applications(ANADA), including those drugs under CVM Procedure for Conditional New Animal Drug Applications (CNADA).
• Post-Approval CMC Submission (PAS, CBEs, MCSR): Our services include handling post-approval CMC submissions, such as Changes Being Effected (CBEs), Prior Approval Supplements (PAS), including annual Minor Changes and Stability Reports (MCSR), ensuring timely and accurate submissions.
• Incomplete Letter Response: We assist in crafting comprehensive and effective responses to incomplete letters, addressing regulatory concerns and facilitating the approval process.

Analytical Services

We understand the critical role that accurate and reliable testing plays in the development and quality control of veterinary drugs. Our comprehensive suite of services encompasses regulatory and technical guidance for, method development/validation and stability data review, etc.

1. Veterinary Formulation Assessment: Leveraging advanced analytical techniques, we assess veterinary formulations to help ensure development of an effective, safe, and regulatory compliant drug product.
2. Stability Testing Review: Our experts conduct rigorous stability data reviews, providing you with valuable insights into the shelf life and storage conditions of your veterinary products.
3. Method Development/Validation: DSI experts have in-depth consulting experience in method development and validation and can ensure the precision and reliability of analytical procedures tailored to your specific veterinary products.

Quality Assurance Services

At DSI, we recognize the pivotal role of ensuring the quality and safety of veterinary products. Our comprehensive Quality Assurance services include veterinary GMP audits to 21CFR211, quality system implementation, and veterinary quality management consulting, all tailored to meet the highest industry standards.

1. Veterinary GMP Audits: DSI conducts thorough Good Manufacturing Practice (GMP) audits, evaluating processes to ensure compliance with regulatory guidelines. Our detailed assessments provide actionable insights to enhance your manufacturing practices.
2. Quality System Implementation: We assist you in implementing robust quality systems, streamlining your operations and ensuring consistent quality across all aspects of your veterinary product development and manufacturing processes.
3. Veterinary Quality Management Consulting: Our experienced consultants provide expert guidance, helping you navigate the complexities of veterinary quality management. We offer strategic solutions to optimize your quality control procedures.

Drug substance and Drug Product Services

 At DSI, we offer a comprehensive suite of services for every stage of veterinary drug substance and drug product development and manufacturing, guaranteeing top-notch quality and efficiency throughout the entire process.

1. Drug Substance (DS) Process Development: We specialize in advancing Drug Substance processes, tailored for each development phase from Target Product Profile (TPP) and Critical Process Parameters (CPP) through to Reference Standards Materials (RSMs). Our approach ensures a smooth transition from concept to commercialization, aligning with stringent regulatory standards.
2. Advocacy in Collaborations with CDMOs/CROs: We champion your interests in collaborations with Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs), emphasizing the core values of respect, trust, and effective communication in all partnerships.
3. API Development and Manufacturing: Offering full-scale development and manufacturing support for Active Pharmaceutical Ingredients (APIs) used in veterinary medicine, tailored to meet stringent regulatory standards and quality requirements.
4. Veterinary Formulation Development Support: Our expert team provides tailored formulation development support, optimizing veterinary drug formulations for maximum efficacy and stability. We focus on enhancing the effectiveness of your products, ensuring they meet the specific needs of the market.
5. Manufacturing Support for Animal Drugs: DSI offers manufacturing support services designed to streamline the production of animal drugs. Our solutions are geared towards improving efficiency, reducing production costs, and ensuring compliance with industry regulations, thereby enhancing the overall manufacturing process ensuring continued supply to the market
6. Ongoing Support and Optimization: Beyond formulation and manufacturing, we provide continuous support to enhance productivity and reduce costs in veterinary manufacturing. Our team collaborates closely with you and your CDMO/CRO business partners, offering ongoing optimization strategies to maintain the highest quality standards while maximizing efficiency.

Compliance and Regulation

Understanding and complying with Veterinary International Conference Harmonization (VICH) and regulatory guidelines set forth by organizations such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) is imperative. We stay updated with the latest regulations, ensuring your products meet the necessary standards for quality, safety, efficacy, and market approval for veterinary products.

What distinguishes DSI is our comprehensive approach to CMC expertise, providing a convenient "one-stop shop" solution. Unlike other CMC consulting firms, we offer a wide range of veterinary CMC support encompassing strategic guidance and hands-on involvement, ensuring the successful development of protocols, pre-submission conference meeting requests, formulation development reports, VMF,  INADs, JINDA, NADAs, ANADAs,  and CNADA. Our experienced consultants, each with 25 or more years of expertise, are capable of addressing various challenging domains, including veterinary drug substances and new animal drugs, medicated feeds spanning Type A medicated articles, Type B and Type C medicated feeds, Biologics, Peptides and specialized areas of living cell therapies such as stem cells, Plasmid DNA, Nano lipid particles, and AAV vector-based gene therapy.

Why Choose DSI?

• Expertise in Action: Our hands-on, deliverable-oriented Senior SMEs are self-starters. Our adaptable partnership approach provides a pragmatic solution for accessing specialized CMC knowledge precisely when and how you need it, enhancing productivity and bridging gaps in hiring.

• A Comprehensive Team: With over 60 SMEs strategically organized, we function as a versatile one-stop shop, covering all subdisciplines of CMC on a phase-appropriate basis.
• Broad CMC Spectrum: Leveraging a diverse range of CMC subject matter expertise, we offer high-level strategic advice and hands-on support for various needs, pre-submission conference meeting requests, INAD/JINAD crafting, Quality Assurance SOPs and process development, and CMC technical section and master file preparation.
• Global Regulatory Proficiency: Our expertise extends across most regulated regions, with DSI recognized for its outstanding regulatory-CMC personnel providing strategic insights.
• Excellence in Management: Renowned for our regulatory writers and project management, we prioritize client input, offer flexibility to meet diverse needs, and maintain meticulous version control throughout the submission process.

Partner with DSI today to empower your veterinary medicine and animal feed initiatives. For inquiries or to discuss your project, contact us.