Generic Drugs

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.

Generic drugs are just as safe and just as effective as their brand-name counterparts, and they are a cost-effective way of achieving substantial savings

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.

Our Expertise for the Generics Industry Includes

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:

Regulatory Dossier Preparation

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.

Bioequivalence and Clinical Study Support

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.

Quality and Manufacturing Compliance

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.

Pharmacovigilance & Safety Monitoring

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.

Scientific & Medical Writing

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.

Market Access & Strategy Support

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.

Generic Drug Segments We Serve

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:

Oral Solid Dosage Forms (OSD)

Tablets, capsules, and powders, supporting formulation, regulatory submissions, and bioequivalence documentation.

Injectables & Parenter
als

Sterile products, including vials, ampoules, and pre-filled syringes, with guidance on stability, sterility assurance, and regulatory dossiers.

Topical & Transdermal Formulations

Creams, gels, ointments, patches, covering quality control, clinical evaluation, and regulatory compliance.

Respiratory & Inhalation Products

Metered-dose inhalers, nebulizers, and dry powder inhalers with regulatory strategy and bioequivalence support.

Orphan & Niche Generics

Rare disease therapies or hard-to-manufacture generics, supported with tailored regulatory and clinical guidance.

Biologics & Biosi
milars

Complex protein-based generics, with support for analytical characterization, comparability studies, and regulatory submissions.

Over-the-Counter (OTC) Generics

Non-prescription drugs with assistance in labelling, safety data, and regulatory compliance for global markets.

Are Generic Drugs as Good as Brand Names?

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”)

Why the Generics Sector Matters

Generic medicines play a critical role in global healthcare by making essential therapies more affordable while maintaining safety, efficacy, and quality.
With patent expirations creating opportunities, competition from generics helps reduce overall healthcare costs and expand access.
However, the generics landscape is complex manufacturers face regulatory, scientific, and market challenges in bringing generics to market and sustaining competitiveness.

Generic Drugs Must Meet the Same High Standards as Brand-Name Drugs to Receive FDA Approval

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:

The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
The generic medicine has the same strength, dosage form (such as a tablet or an injectable), and route of administration (such as oral or topical).
The generic medicine is manufactured under the same strict standards as the brand-name medicine.
The label is the same as the brand-name medicine’s label (with certain exceptions).
The generic medicine is bioequivalent to the brand-name medicine.

Where Our Authors Publish

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

Our Expert Medical Editors

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.

What Our Client Says About Us

“

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

Testimonials

Learn how Pubrica’s meta-analysis service has empowered researchers to generate high-impact, publication-ready analyses that advance evidence-based research and elevate their academic and clinical visibility. Here is what our clients say:

Testimonial Slider

"Pubrica’s team provided exceptional support throughout my meta-analysis cardiovascular drug efficacy. Their adherence to PRISMA guidelines and attention to statistical detail helped me publish in the European Heart Journal. Highly recommended"

— Dr. Anna Müller

Cardiologist, University Hospital Munich, Germany

"The meta-analysis manuscript I co-authored with Pubrica’s experts was accepted by BMC Public Health without major revisions. Their data synthesis and transparent methodology were critical to this success."

— Dr. Rohan Mehta

Public Health Researcher,
All India Institute of Medical Sciences (AIIMS), India

"Thanks to Pubrica’s guidance, our meta-analysis on paediatric nutrition was published in The Lancet Child & Adolescent Health. The methodological rigor and rewriting support were key contributors to the paper’s clarity and impact."