Work Better Together.

wonderful serenity has taken possession of my entire soul, like these sweet mornings of spring which I enjoy with my whole heart

  • Western can be Your Trusted Partner
  • Western BioPharma can be Your US Agent with FDA
  • < 24-hour turnaround time to Answer Your Project Related Queries
  • Full Regulatory Services by Western’s Senior Regulatory Experts for Branded Pharmaceuticals, Generics, and Biologics
  • Extensive CMC & Regulatory CMC Experience
  • Committed to deliver High-Quality Services that exceeds Our Client’s Expectations
  • Reliable, Cost-effective, and Scalable Services
  • Medical & Scientific Writing
  • Clinical & Pharmacometrics Services: Clinical Development, PKPD, PBPK, Pop PK, IVIVC
  • Experienced and Passionate Team

Welcome To


Western BioPharma Services is a US based company that provides a wide range of services to Pharmaceutical and Biotechnology companies across the globe to develop FDA approvable therapeutic products. We specialize in US Regulatory, Chemistry Manufacturing and Controls (CMC), Regulatory CMC, Regulatory and Scientific Writing, Phamracometrics, Clinical Development, Pharmacometrics, Quality Assurance and Compliance. Our team consists of highly skilled and experienced professionals who are dedicated to delivering innovative and high-quality services and solutions to our clients. We understand that science is constantly evolving, and we strive to stay ahead of the curve by continuously learning and adapting to the latest innovations, ICH, and US FDA guidelines.


Our services



Regulatory Services

Successful regulatory strategy and its implementation is critical for a successful project and health authority application while saving significant amount of time and money for your organization.

Read More

CMC Services

CMC requirements depend on the stage of development, dosage form, physicochemical characteristics of the drug, patient population, and indication.

Read More

Quality Assurance

cGxP Adherence and Regulatory Compliance is the heart of Biopharmaceutical development which is essential for the approval of marketing applications while ensuring the quality, safety, and efficacy of medicinal products.

Read More

Pharmacometrics Services

We noted increased emphasis on Pharmacometrics analysis by US FDA and Sponsors to decrease number of clinical trials or study size while reducing unnecessary drug exposures to subjects.

Read More

Clinical Development

Western BioPharma can provide clinical development support with various indications. With our clinical strategy development, we offer guidance at each step of the process to ensure compliance. 

Read More

Medical & Scientific

We understand the criticality of Medical/Scientific writing in regulated BioPharmaceutical Industry. Western group has proven record in authoring clear, persuasive, concise documents.

Read More


We Are The Leader In BioPharma Services.

At WESTERN, we are dedicated to catering to the requirements of small and medium-sized Pharma & Biotech Companies. Our team of top experts, also known as our A-team, will give your project their undivided attention. Our company has a strong focus on Regulatory Affairs, CMC and Clinical Research which is reflected in the knowledge and skills of our employees. They are committed to collaborating with you closely to create treatments for patients who require them. Our core values are centered around maintaining the essential attributes necessary to achieve these objectives.

+ 0
Years exprience
0 %
Happy Clients
0 %
Happy Clients
0 k
User Customer

Who We are

Why You Choose Us?

WESTERN BIOPHARMA Services, acknowledges the intricate and ever-changing regulations that oversee the approval of drugs. Our goal is to collaborate and utilize our collective knowledge, skills, and experience to successfully navigate the clinical development process and provide cost-effective, pioneering medications to all patients in need. As a BioPharma Consulting Services Firm, we strive to gain the confidence and admiration of our worldwide clients, staff, and patients through proficiency and empathy.

Committed to deliver High-Quality Services that exceeds Our Client’s Expectations

We unlock your ability to deliver data to the people and machines where decisions are made.