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Camargo Pharmaceutical Services

Camargo Pharmaceutical Services

Camargo Pharmaceutical develops and executes comprehensive drug development programs tailored to meet the needs of your specific compound. Our expert team has years of experience in the full spectrum of drug development.

 

Our goal is to work with your team to develop a comprehensive program including a timeline with important milestones and costs. We manage every facet of your program: formulate and test the drug product, conduct clinical studies, and guide you through the FDA application submission process-specializing in 505(b)(2). The 505(b)(2) submissions have special requirements; you need the experts at Camargo to guide you through the process.

 

Increase your speed-to-market with Camargo as your strategic partner.

 

Drug Development Services

• Pre-clinical

• Feasibility assessments

• CMC/CMO services

• Clinical program development

• Pharmacokinetics

• Phase I

• Phase II

• Phase III

• Phase IV

• Regulatory review/preparation/submission

• IND

• NDA

• ANDA

• 505(b)(2)

 

Therapeutic Expertise.

 

Camargo's associates are accomplished in a wide variety of therapeutic areas:

• Anti-fungal

• Anti-infective

• Anti-inflammatory

• Cardiovascular

• Central nervous system

• Contraception

• Dental

• Dermatology

• Diagnostics

• Endocrinology

• Female sexual dysfunction

• Gastrointestinal

• Genito-urinary

• Hormone replacements

• Immunology (including allergy)

• Infectious disease

• Migraine

• Oncology

• Pain management/anesthetics

• Respiratory

• Sleep disorders

• Women's health

Related resources

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505(b)(2): 10 Years and Running with 300+ Approvals

505(b)(2): 10 Years and Running with 300+ Approvals

Content provided by Camargo Pharmaceutical Services | 21-Oct-2013 | Data Sheet

In 2003, the FDA unleashed the 505(b)(2) pathway. With a record 47 approvals in 2012, the pathway is helping product developers secure up to 7 years of...

(b)(2) or not (b)(2)? That is the question.

(b)(2) or not (b)(2)? That is the question.

Content provided by Camargo Pharmaceutical Services | 19-Aug-2013 | White Paper

505(b)(2) is more than a regulatory pathway - for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development...

Understanding the 505(b)(2) Approval Pathway

Understanding the 505(b)(2) Approval Pathway

Content provided by Camargo Pharmaceutical Services | 11-Jun-2013 | White Paper

When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway...

505(b)(2): It’s A Different Animal

505(b)(2): It’s A Different Animal

Content provided by Camargo Pharmaceutical Services | 13-May-2013 | Data Sheet

505(b)(2) is more than a regulatory pathway — for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development...