Finished formulation and API registration is a complex undertaking, demanding a deep understanding of intricate legal frameworks, stringent quality standards, and rigorous evaluation processes by pharmaceutical regulatory bodies. With a decade of proven experience supporting businesses in the pharmaceutical ingredient sector, GlandCore proudly offers professional and comprehensive Finished Formulation and API Registration services. We empower you to navigate all regulatory hurdles, saving valuable time and resources, allowing you to focus on your core manufacturing and business objectives. 

Finished formulation and API registration

We understand that bringing a finished drug product or an active pharmaceutical ingredient (API) to market is more than just research and development. It’s a challenging legal journey requiring meticulous preparation of dossiers, comprehensive documentation, and robust evidence demonstrating quality, safety, and efficacy. Any misstep in the registration process can lead to significant delays, or even prevent your products from reaching patients and partners. 

GlandCore leverages a team of highly experienced regulatory experts possessing in-depth knowledge of Vietnam’s Drug Administration (DAV) regulations and international guidelines to deliver comprehensive consultation and steadfast support throughout the entire finished formulation and API registration process. From the initial dossier preparation, where we develop a tailored registration strategy and meticulously compile all required scientific and legal documentation, through to successful submission, diligent monitoring of the evaluation progress, and efficient resolution of any potential issues, we are your dedicated partner in navigating this critical pathway.

COMPREHENSIVE FINISHED FORMULATION AND API REGISTRATION SOLUTIONS – YOUR PATHWAY TO MARKET SUCCESS 

In Vietnam’s increasingly dynamic and globally integrated pharmaceutical industry, ensuring strict adherence to the legal regulations governing the registration of finished formulations and APIs is paramount to the success of every pharmaceutical enterprise. With 10 years of dedicated experience in the pharmaceutical ingredient sector, GlandCore deeply understands the multifaceted challenges that pharmaceutical manufacturers encounter during this critical process. 

Therefore, we have developed a specialized and comprehensive Finished Formulation and API Registration service, providing end-to-end support from the initial preparation stages right through to the successful acquisition of your marketing authorization. 

GlandCore’s services are designed to act as a seamless extension of your team, freeing you from the complexities of intricate administrative procedures. We offer a streamlined, transparent, and scientifically rigorous workflow, executed by our team of experts who possess extensive specialized knowledge and a wealth of practical experience in pharmaceutical regulations. 

GLANDCORE’S SYSTEMATIC FINISHED FORMULATION AND API REGISTRATION PROCESS ENCOMPASSES KEY STAGES: 

  • Initial Dossier Receipt and Thorough Evaluation: We begin by receiving detailed information about your finished formulation or API and conducting a comprehensive preliminary assessment of the registration viability. 
  • In-depth Regulatory and Technical Consultation: GlandCore’s team of seasoned experts provides you with detailed guidance on current legal regulations, precise dossier requirements, stringent quality standards, and all necessary testing protocols. 
  • Strategic Development of an Optimal Registration Pathway: Based on the specific characteristics of your product and your overarching business objectives, we will collaboratively develop a highly effective registration strategy, designed to minimize timelines and optimize costs. 
  • Comprehensive Support in Preparing and Finalizing the Registration Dossier: Our team provides expert guidance and hands-on support in the meticulous collection, systematic organization, and thorough completion of all essential documentation in strict accordance with regulatory authority requirements. 
  • Expert Drafting of Specialized Technical Documentation: Leveraging our deep understanding of pharmaceutical science and technical regulations, GlandCore’s experienced team will accurately and comprehensively prepare all required technical documents. 
  • Efficient Dossier Submission and Proactive Evaluation Monitoring: We will act as your authorized representative, expertly submitting the registration dossier to the relevant regulatory authorities and diligently monitoring the progress of the evaluation process. 
  • Swift and Effective Resolution of Requests and Emerging Issues: Throughout the evaluation process, should any supplementary information requests or unforeseen issues arise, GlandCore will provide prompt and effective support to ensure a swift resolution. 
  • Successful Marketing Authorization Receipt and Comprehensive Post-Registration Support: Following the successful receipt of your marketing authorization, we continue to offer support for any related post-registration procedures, ensuring a smooth transition to market. 

Partnering with GlandCore means gaining more than just a registration service provider; you gain a trusted ally, consistently supporting you at every step of your journey, including navigating the complexities of finished formulation and API registration. We are committed to delivering unparalleled professionalism, demonstrable efficiency, and complete transparency throughout every stage of the registration process. This empowers you to confidently introduce your high-quality pharmaceutical products to the market, contributing significantly to the sustainable growth of Vietnam’s healthcare sector.

Let GlandCore expertly navigate the complex regulatory landscape for you, allowing you to focus on your core mission: delivering the best possible healthcare solutions to the community.