Expert Pharmaceutical and Biotech Consulting Services
Partnership. Personified.
Discover Cain BioConsulting
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Innovative Solutions
Cain BioConsulting is a specialized consulting firm led by a principal with over 35 years of experience in the development and commercialization of pharmaceutical drug products. The firm brings deep expertise in Chemistry, Manufacturing, and Controls (CM&C), serving as a vital liaison to Contract Development and Manufacturing Organizations (CDMOs).
Areas of Expertise
- Pharmaceutical Development and Commercialization: Extensive background in guiding products from early development through to market launch.
- CM&C Leadership: Proven proficiency in all aspects of Chemistry, Manufacturing, and Controls, ensuring product quality and regulatory compliance.
- CDMO Collaboration: Years of hands-on experience working within CDMOs and partnering with companies sponsoring new drug entities, facilitating seamless communication and project management.
- Regulatory Writing and Inspections: Skilled in preparing regulatory documents and supporting clients during regulatory inspections to meet compliance standards.
- Cell Therapies and Medical Devices: Deep experience in the development of innovative cell therapies and medical devices, supporting clients in bringing advanced therapies and combination devices to market.
Expertise You Can Trust
Pharmaceutical Expertise
Collaborative CDMO Relationships
Pharmaceutical Expertise
With over 35 years of experience working for and with CDMOs, Cain BioConsulting excels in the development and commercialization of pharmaceutical drug products. We specialize in injectable products. Trust us to guide your product to market success.
CM&C Excellence
Collaborative CDMO Relationships
Pharmaceutical Expertise
Our comprehensive knowledge in CM&C sets Cain BioConsulting apart. We can help you set up aseptic drug manufacturing and assist with all your regulatory writing and preparations. We have helped deliver over a hundred products to the market.
Collaborative CDMO Relationships
Collaborative CDMO Relationships
Collaborative CDMO Relationships
At Cain BioConsulting, we leverage our network of CDMOs and CROs to enhance your project outcomes. Our collaboration ensures that your product development is efficient, effective and in the hands of someone you can trust.
Service Offerings
CDMO Management
Our experts work tirelessly to help you choose the best CDMO for your product. We can also act as the project lead, person in plant and help in managing the CDMO/project. The Principal has helped lead several drug product CDMOs in the past. We understand the dynamics, challenges and potential pitfalls of working with partners.
CM&C Support
We will work closely with you and your Regulatory function to ensure that you have all the necessary systems and documents in place to support Regulatory submissions. We can also help prepare the required batch records, procedures, and SOPs.
Regulatory Compliance
We can help prepare and improve your Regulatory submissions. We can audit your CDMOs and ensure CAPAs are completed appropriately. We can also conduct mock PAIs and ensure your CDMO is ready for PAI. The organization is Quality and Compliance focused.
M&A Diligence
We have been involved in many Mergers & Acquisitions. We can assist in M&A diligence activities supporting both strategic buyers and private equity institutions. While we have performed such support evaluating Medical Device, biologic and cell therapy companies, the team specializes in pharmaceuticals with deep experience with aseptic manufacturing of both small and large injectable molecules.
Operations Support
If you need help in complex manufacturing systems and process optimization, our team can deliver the results you need. We can ensure sterility assurance and aseptic processing. We can deliver team support and training, conduct thorough investigations, and oversee all manufacturing operations and supporting activities including visual inspection, validation, packaging and labeling.
additional Biotechnolgy Solutions
While pharmaceuticals (drug substance and drug product) is a key area of support, we are well versed in performing the same services for medical device, combination product, biologic, and cell therapy companies.