Achieve seamless regulatory compliance for your generic products with our end-to-end support. We handle bioequivalence studies, documentation, and submissions, enabling you to bring high-quality generics to market efficiently.
In today’s pharmaceutical landscape, generics industry services are critical to providing affordable access to medicines worldwide. However, delivering high-quality generics requires rigorous scientific, regulatory, and operational support, not just cost efficiency. That’s where Pubrica steps in. We offer end-to-end capabilities tailored for generics manufacturers, helping you navigate regulatory complexity, ensure quality and compliance, and streamline market entry.
At Pubrica, we specialize in providing comprehensive support for generics pharmaceuticals, encompassing regulatory affairs, market access strategies, and scientific communication. Our team of experts collaborates closely with clients to navigate the complexities of the generics sector, ensuring compliance and facilitating market entry.
Generics account for 90 percent of prescriptions dispensed in the U.S., but only 13.1 percent of the total drug costs. The thousands of generics available today are rigorously tested by the FDA and must demonstrate that they are the same medicine with the same active ingredients, strength, and dosage as their brand-name counterparts.
At Pubrica, we specialize in supporting generic pharmaceutical companies across every stage of the product lifecycle. Our deep understanding of regulatory requirements, scientific rigor, and market dynamics enables us to help you bring safe, effective, and compliant generic drugs to patients worldwide. Our expertise spans the following areas:
We provide end-to-end support for bioequivalence studies, including protocol development, study monitoring, data analysis, and report writing. Our experts ensure that your generic products demonstrate therapeutic equivalence to reference drugs efficiently and accurately.
We offer comprehensive post-marketing surveillance and pharmacovigilance services, including adverse event reporting, signal detection, and risk management, ensuring ongoing safety and regulatory compliance of your generics.
We assist with market intelligence, competitive analysis, and pricing strategies to help your generic products gain faster market acceptance and maximize commercial success. Our comprehensive approach includes identifying key market trends, analyzing competitor landscapes.
We prepare comprehensive generics regulatory submissions, including ANDAs (Abbreviated New Drug Applications) and DMFs (Drug Master Files), ensuring full compliance with global regulatory standards. Our team meticulously compiles clinical, preclinical, and manufacturing data to accelerate approvals and minimize delays.
Our specialists assist with GMP (Good Manufacturing Practice) compliance, process validation, stability studies, and quality documentation, helping you maintain product integrity and meet regulatory expectations across global markets.
Our experienced medical writers create precise, high-quality documents, including clinical study reports, regulatory submissions, and scientific publications, making sure your data communicates the required information clearly and effectively.
At Pubrica, we provide specialized support across a broad spectrum of generic drug segments, helping manufacturers ensure regulatory compliance, market readiness, and product success. Our expertise spans the following categories:
Tablets, capsules, and powders, supporting formulation, regulatory submissions, and bioequivalence documentation.
Sterile products, including vials, ampoules, and pre-filled syringes, with guidance on stability, sterility assurance, and regulatory dossiers.
Creams, gels, ointments, patches, covering quality control, clinical evaluation, and regulatory compliance.
Metered-dose inhalers, nebulizers, and dry powder inhalers with regulatory strategy and bioequivalence support.
Rare disease therapies or hard-to-manufacture generics, supported with tailored regulatory and clinical guidance.
Complex protein-based generics, with support for analytical characterization, comparability studies, and regulatory submissions.
Non-prescription drugs with assistance in labelling, safety data, and regulatory compliance for global markets.
Generic pharmaceutical manufacturers must prove to the FDA that their version of a drug:
Contains the same active ingredient
Is identical in strength, dosage form, and route of administration
Has the same indications, dosing, and labelling
Provides the same efficacy and safety profile to patients ("bioequivalent")
The FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine. Generic drug applicants must show that the generic medicine is the same as the brand-name in the following ways:
Our authors share Pubrica's expert content in top-tier journals, conferences, and platforms, maximizing and amplifying its recognition and reach. Our placement will enhance our visibility and elevate our standing in an authoritative capacity.
Paper Title: The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs
Author: Borgheini G
Journal Name: Clinical Therapeutics
Publisher: Elsevier
Impact factor: 3.6
Pubrica's team of industry specialists offers unrivalled expertise and perspectives to provide complete solutions with precision and originality. Through a mix of both experience and specialization, they strive for excellence in everything they do.
PHD - Generics
PHD - Generics
PHD, FIAMS, DMRD, DMRE, DNB - Medical
Pubrica’s expertise in generics has been instrumental in accelerating our product approvals. Their detailed regulatory support and thorough documentation helped us navigate complex compliance requirements seamlessly.
— Dr. Emily Johnson
Head of Regulatory Affairs, PharmaGenics Inc.
USA
Working with Pubrica has enhanced our generics development process. Their team provided precise guidance and robust data management support, ensuring our products meet global standards efficiently.
— Dr. Markus Bauer
Director of Operations, MedicaGen GmbH
Germany
Their team’s insights into generics compliance and dossier preparation helped us reduce time-to-market significantly. Pubrica is a trusted partner for any pharmaceutical company aiming for global reach.
— Dr. James Fletcher
Regulatory Lead, Global Pharma Solutions
UK
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