Independent Consultant - Pharma & Biotech 

Our Company:

Trusted Advisors | Streamlining Product Development & Manufacturing

Expertise Seeking: Leverage our team of experienced consultants for efficient seasonal/remote support across your entire product (development & manufacturing) lifecycle.

• Product Lifecycle (CMC) Expertise: Our team has extensive experience with >150 successful product launches, building high-performing teams (e.g., Filed numerous products in the USA, launched a very successful pharmaceutical company from groundup; e.g.TQ Pharma. We offer specialized knowledge in Strategic Vision & Growth, Operational Excellence, Quality & Regulatory Compliance, Cross-Functional Collaboration, and Financial Acumen:

  1. Clinical Studies 

  2. Regulatory Management and Strategies 

  3. Quality Assurance 

  4. FDA Communications (i.e Deficiency letters, CRL, CDL) 

  5. FDA Audit Remediation & Support 

  6. Analytical and Bioanalytical Development & Validation

  7. Stability Studies Management  

Ready to add value with us in any area of the above? Let's connect!