Pharmaceutical Product Development Services

Pharmaceutical Product Development Services

At US Specialty Formulations (USSF), we specialize in pharmaceutical product development and pharmaceutical formulation development, guiding innovations from concept to commercialization. Our expertise in CGMP-compliant manufacturing, robust formulation strategies, and regulatory support ensures that your pharmaceutical product reaches the market efficiently and meets the highest industry standards.
Whether you require sterile injectables, oral liqiuid dosages, topical formulations, or tailored pharmaceutical solutions, we offer comprehensive services customized to your specific needs. Partner with US Specialty Formulations to confidently expedite your pharmaceutical innovation.
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Why Choose US Specialty Formulations for Pharmaceutical Product Development?

The pharmaceutical industry demands precision, compliance, and efficiency in product development. At USSF, we bring extensive expertise in:

  • Innovative formulation development for sterile injectables, oral tablets, and topical solutions.
  • State-of-the-art analytical testing to ensure product stability and efficacy.
  • Regulatory expertise to support FDA, EMA, and international compliance.
  • CGMP-compliant manufacturing for clinical and commercial-scale production.

With US Specialty Formulations, your pharmaceutical product development journey is in the hands of industry-leading experts committed to quality, innovation, and success.

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Comprehensive Pharmaceutical Formulation Development

Developing a successful pharmaceutical product requires a well-structured formulation strategy. Our pharmaceutical formulation development services focus on creating stable, effective, and scalable formulations that comply with regulatory standards.
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Pre-formulation Studies

Understanding physicochemical properties to determine the best formulation approach.
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Excipient Selection

Identifying the most compatible excipients to enhance stability and bioavailability.
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Dosage Form Development

Creating injectables, oral tablets, capsules, topical formulations, and more to suit your therapeutic needs.
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Stability Studies

Conducting real-time and accelerated stability testing to ensure product longevity.
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Optimization for Manufacturing

Scaling formulations from R&D to commercial production with seamless technology transfer.

At US Specialty Formulations, we understand that every pharmaceutical product requires a customized formulation approach to ensure optimal performance, stability, and patient compliance.

Analytical Development & Validation

Analytical testing plays a critical role in pharmaceutical product development by ensuring quality, consistency, and regulatory compliance. Our analytical development and validation services support all phases of drug development, from early research to commercial manufacturing.
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Method Development & Validation

Creating robust analytical methods for accurate product characterization.
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Stability Testing

Conducting long-term and accelerated stability studies to evaluate product shelf-life.
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Impurity Profiling

Identifying and quantifying potential impurities in drug formulations.
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Dissolution & Bioavailability Studies

Ensuring optimal drug release and absorption characteristics.
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Quality Control & Batch Release Testing

Conducting comprehensive testing to meet FDA, EMA, and ICH guidelines.

At US Specialty Formulations, we integrate cutting-edge analytical techniques to ensure the highest standards of quality, efficacy, and safety for your pharmaceutical products.

CGMP Manufacturing for Clinical & Commercial Production

US Specialty Formulations operates a state-of-the-art CGMP manufacturing facility designed to meet the rigorous demands of pharmaceutical product development. We offer flexible, scalable, and fully compliant manufacturing solutions for both clinical trial batches and commercial-scale production.

Our Manufacturing Capabilities Include:

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Sterile Injectables

Formulated as liquid and lyophilized (freeze-dried) products.
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Oral Liquid Dosage Forms

Suspensions and flavored formulations
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Topical Formulations

Serums, extracts and ointments for dermatological and transdermal applications.
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Personalized & Small-Batch Manufacturing

Custom solutions for specialty pharmaceuticals and orphan drugs.

With US Specialty Formulation’s advanced CGMP manufacturing, you can trust that your pharmaceutical product is produced under strict quality controls and regulatory compliance.

Regulatory Support & Compliance

The pharmaceutical regulatory landscape is constantly evolving, requiring expert guidance to ensure smooth product approvals and market entry. US Specialty Formulations provides comprehensive regulatory support, helping you navigate complex FDA, EMA, and international submission processes.

Our Regulatory Services Include:

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FDA IND, NDA, and ANDA Submissions

Assisting with regulatory documentation and filings.
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CMC (Chemistry, Manufacturing, and Controls) Compliance

Ensuring your product meets regulatory expectations.
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Regulatory Strategy Development

Crafting the most efficient pathway for clinical and commercial success.

With US Specialty Formulations, you gain a trusted regulatory partner to guide you through every phase of pharmaceutical formulation development and approval.

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Custom Pharmaceutical Solutions Tailored to Your Needs

At US Specialty Formulations, we understand that every pharmaceutical product is unique. That’s why we offer customized development and manufacturing solutions to meet your specific therapeutic, market, and regulatory requirements. We are specialists in boutique manufacturing. Whether you need:

  • A new formulation for an existing drug.
  • A novel delivery system to enhance bioavailability.
  • A scalable manufacturing process for commercialization.
We provide tailored strategies to ensure your pharmaceutical product development is successful from start to finish.
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Partner with US Specialty Formulations Today

Choosing US Specialty Formulations means partnering with a leader in pharmaceutical product development and pharmaceutical formulation development. Our expertise, cutting-edge technology, and regulatory knowledge make us the ideal partner to bring your pharmaceutical innovation to market. Contact USSF for a discussion on how we may partner with you on your project.