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21159 Pharma has a team of experienced consultants (average 25 years of experience) on hand to support CMC product development and other activities. If you have specialized needs, we can find the expert with the necessary experience.

Consulting resources are useful for early stage orphan drug companies, mid-size pharmaceutical companies needing short term resource when positions become vacant, private equity requiring management, and law firms requiring technical expertise in litigation and expert witnesses.

Development Team

We can quickly put together a development team with some or all of the disciplines listed below to manage the program.

Formulation Development

Experienced formulators in all dosage forms ranging from pre-formulation through  Phase 3 and commercial.  Helping to solve formulation issues during development.  Working to develop line extensions then finding vendors to perform the work. The formulators also have scale up expertise in most dosage forms through to the final commercial product.

Analytical Chemistry

API process development, method development and validation, problem solving with analytical methods and validation investigations.

Regulatory Support

Initial filing IND’s, NDA’s and ANDAs and  updates as required. Review company press releases for regulatory accuracy.

Quality and Qualified Person (QP)

Quality support through facility audits (in person or virtual), product development and product release. Quality and technical agreement support and negotiation. Our QP is based in Europe and can help with Quality related issues for European clinical studies.

Project Management & Supply Chain

Manage the development process from inception to completion of the project.  Provide supply chain support from launch through managing of commercial product for API, Drug Product and packaging.

Business Development

Negotiation of the business terms with outsourcing vendors (CDMO, CMO, CRO) for Master Service and Commercial Supply Agreements. Identification of outsourcing vendors and preparation of RFPs. Product licensing identification of partners and facilitation of  the licensing process.

Finance

Experienced pharmaceutical financial professionals with both private and public company experience. Accounting system implementation and management, financial statement preparation and analysis, corporate due diligence, contract and debt negotiations.

Develop and lead the budget process and evaluate cost driving trends.  Cap table maintenance and investor relations. Vendor management including CRO and clinical site budget oversight. Provide financial support to strategic transactions.

Legal

Pharmaceutical contract negotiation experience as well as PIV litigation.  Expert technical witnesses for litigation cases in formulation development, crystal structure and Polymorph identification.

Clinical Program Management

Extensive experience of managing clinical studies in the US from Phase 1 through  Phase 3 working either independently or with CRO’s.  A network of independent Clinical Research Associates (CRA’s) throughout the US to monitor studies. Design and Management of Electronic Data Capture (EDC) systems based on study design.

Other Resources

Experts in facility design, Clinical Statistics and Clinical trial design.  If you need expertise, we will find it for you.

How Can We Help You With Your Resource Needs?