Pharmaceutical Formulation Projects | CMC Pharmaceuticals Inc.

OUR CLIENTS

From small startups to established pharmaceutical companies, we support clients in need of technical and chemistry expertise in the pharmaceutical and biotech industries. These include:

Start-ups and emerging companies
Virtual drug development companies
Established pharmaceutical companies
Government drug development programs
Non-profit research institutes
Partners requiring CMC subcontractors for government contracts
Physician-scientists

OUR PROJECTS

CMC Pharma has vast experience with a wide variety of projects and
dosage forms. We’ve successfully led efforts to comply with the FDA’s
stringent requirements on formulation development, analytical development, and process development and control.

EARLY TO LATE STAGE PROGRAMS

Identifying optimal IND enabling project plans through NDA submission and approval
Supporting virtual product development
Identifying drug product dosage forms and drug supply strategy
Executing FDA and ICH compliant formulation, analytical and stability programs

DRUG PRODUCT DEVELOPMENT THROUGH POST APPROVAL

Formulation and process remediation
Identifying stabilizing strategies
Developing analytical methods
CQAs & CPPs and implementing proper control strategy
OOS and OOT investigations
Stability programs and failures
Validation of processes, methods and equipment

Drug Classes include

Small molecules
Biotech/large molecule products, including monoclonal antibodies
Potent compounds
Beta lactams, cytotoxics, hormones
Low solubility drugs
Unstable drugs

cGMP LAB SERVICES

Analytical development
Analytical Method Validation
Release Testing
ICH compliant Stability
Material compatibility

REGULATORY FILINGS

NDAs, supplements, and annual reports
INDs and amendments
FDA meeting requests and briefing documents
Field Alerts, warning letter & 483 responses
Orphan Drug Applications

TECHNICAL BUSINESS SUPPORT

Technical due diligence support of in-license and out-license of pharmaceutical products
Technical support of M&A activities
Business development support for programs with a significant technical component

STRATEGIC AND PORTFOLIO EVALUATION

Development of business plans and investor presentations
Solidifying product development strategies
Evaluation of portfolio options for development
Participate as product development team leaders & members
Identify non-dilutive grant funding

PHARMACEUTICAL SUPPLY CHAIN

cGMP supply chain strategy
cGMP manufacturing plans for development and commercial products
Confirming compliance with cGMPs
CMO and CRO evaluation and selection
Inspection responses to 483 and warning letters

Formulation Projects & Clients