Global Regulatory Compliance
Abiozen is unwavering in its commitment to maintaining and exceeding global regulatory standards. Our regulatory philosophy is rooted in a proactive, compliance-first approach, ensuring that all pharmaceutical products align with the latest international guidelines. We continuously adapt to evolving regulatory landscapes, reinforcing our credibility as a reliable and forward-thinking pharmaceutical partner.
Expert Regulatory Affairs Team
Our regulatory affairs division is led by a team of seasoned professionals with decades of experience in regulatory science, policy interpretation, and global submission strategies. This team manages the entire regulatory lifecycle—from investigational new drug (IND) applications and new drug applications (NDAs) to variation filings and renewals—ensuring timely and accurate documentation for global market entry.
Global Compliance Strategy
Abiozen operates with a comprehensive global regulatory strategy that ensures alignment with authorities such as the U.S. FDA, EMA, MHRA, PMDA, and other regional bodies. Our compliance framework is designed to meet region-specific requirements while streamlining multi-country registrations, thereby accelerating product accessibility for patients across continents.
Lifecycle Regulatory Management
From early development through post-marketing surveillance, our team provides end-to-end regulatory oversight. This includes preparing and submitting regulatory dossiers, supporting clinical trial applications, managing regulatory inspections, and implementing corrective and preventive actions (CAPAs). Our integrated systems and digital documentation workflows ensure full traceability and transparency throughout the regulatory journey.
Patient-Centric Compliance Philosophy
At Abiozen, regulatory compliance is not just a business function—it is an ethical commitment to patient safety and therapeutic integrity. By maintaining the highest standards of quality and regulatory conformance, we strive to build enduring trust among healthcare providers, regulatory authorities, and most importantly, the patients we serve globally.
Abiozen’s regulatory expertise spans a diverse range of international health authorities, enabling seamless market access and ensuring full regulatory compliance in key global territories. Our comprehensive understanding of region-specific requirements allows us to confidently manage submissions, inspections, and post-approval obligations across major pharmaceutical markets.
USFDA Compliance
The United States Food and Drug Administration (USFDA) is known for imposing some of the most rigorous pharmaceutical regulations worldwide. Abiozen maintains full compliance with current Good Manufacturing Practices (cGMP), reinforcing the safety and efficacy of our products distributed within the U.S. market. We uphold stringent data integrity protocols through robust digital systems that ensure traceability, accuracy, and reliability across the product lifecycle. Additionally, our proactive audit preparedness program is designed to maintain continuous readiness for USFDA inspections, fostering a culture of transparency and regulatory resilience.
EMA (European Medicines Agency)
To access the European Union (EU) pharmaceutical market, Abiozen complies with EU Good Manufacturing Practice (EU GMP) standards and expertly manages the centralized authorization procedures mandated by the EMA. Our regulatory team adeptly navigates the European regulatory landscape, addressing the complex requirements for quality, safety, and efficacy. From initial marketing authorization applications to post-approval compliance and pharmacovigilance, we deliver end-to-end regulatory support that facilitates smooth entry into and sustained presence within EU member states.
TGA (Therapeutic Goods Administration – Australia)
For regulatory engagement within Australia, Abiozen ensures comprehensive alignment with the Therapeutic Goods Administration (TGA) standards. We manage the complete process for listing on the Australian Register of Therapeutic Goods (ARTG), ensuring full conformance with safety and performance criteria. Our support extends to post-marketing obligations, including product updates and adverse event reporting, further demonstrating our commitment to quality and compliance within the Australian regulatory framework.
PMDA (Pharmaceuticals and Medical Devices Agency – Japan)
Accessing the Japanese market demands a high degree of precision and regulatory insight. Abiozen’s specialists possess deep familiarity with PMDA protocols, facilitating efficient dossier preparation and submission tailored to Japanese regulatory expectations. Our rigorous documentation standards and quality assurance measures ensure compliance with Japan’s stringent product safety and efficacy requirements, leading to timely and successful approvals.
DCGI (Drugs Controller General of India)
Abiozen actively engages with the Drugs Controller General of India (DCGI) to support both local production and international export operations. We strictly adhere to the Drugs and Cosmetics Act and Rules governing India’s pharmaceutical industry. Our regulatory support spans the approval lifecycle for new chemical entities, generics, and biosimilars. By maintaining full compliance with Indian standards, we ensure that our products are well-positioned for regulatory approval and distribution both within India and globally.
Abiozen offers comprehensive, end-to-end regulatory submission support to expedite global market access for pharmaceutical products. Our dedicated regulatory affairs team streamlines the submission and approval processes for new drugs, generics, biologics, and APIs. By navigating complex global requirements with precision, we ensure our clients achieve timely, compliant, and successful product approvals across multiple jurisdictions.
Drug Master File (DMF) Preparation and Submission
A Drug Master File (DMF) is a cornerstone document required by regulatory agencies to validate the manufacturing integrity of active pharmaceutical ingredients (APIs) and excipients. Abiozen meticulously prepares and submits DMFs that detail manufacturing protocols, facility standards, analytical controls, and safety data. Our structured documentation ensures that global partners and health authorities have full visibility into the quality and consistency of our manufacturing processes.
IND (Investigational New Drug) Applications
The IND application is a critical gateway to initiating human clinical trials. Abiozen manages the complete IND lifecycle, including preclinical study assessments, protocol development, safety evaluations, and submission preparation. Our in-depth understanding of clinical trial requirements allows us to ensure that investigational products meet the criteria for safety and scientific integrity as required by regulatory agencies such as the USFDA and PMDA.
NDA (New Drug Application) & ANDA (Abbreviated New Drug Application) Submissions
For both innovative therapies and generic products, Abiozen provides full-spectrum support in compiling and submitting NDAs and ANDAs. We ensure that all modules—from clinical data and manufacturing processes to labeling and pharmacovigilance—are accurately compiled in accordance with regulatory expectations. Our expertise also extends to managing post-approval changes, supplements, and lifecycle updates, maintaining long-term product compliance.
Biologics License Applications (BLA)
Biologics require highly detailed and specialized regulatory documentation. Abiozen’s regulatory experts develop and submit comprehensive BLAs that address the unique challenges of biologic development, including cell line characterization, process validation, and immunogenicity assessments. We ensure that all data submitted aligns with the complex regulatory frameworks governing biologics, facilitating smooth reviews and successful licensure.
Market Authorization Applications (MAA)
To access European markets, Abiozen expertly manages the preparation and submission of Market Authorization Applications (MAAs). Whether pursuing centralized, decentralized, or mutual recognition procedures, our regulatory team crafts region-specific dossiers and manages communications with the EMA and national agencies. Our agile submission approach ensures timely approvals and strategic market entry across the EU.
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