ABOUT US

Tailored CMC Drug Product Assistance

leverages seasoned professionals to take your program from bench scale to commercial optimization. By understanding the challenges of scale-up and production, as well as the characteristics of most manufacturing process trains, we can help you plot an efficient course for your drug product program.

offers expertise in areas of CMC Drug Product Development/Manufacturing, CDMO Management/Oversight, PIP, CMC Regulatory Authoring & Advise, Quality Assurance, CMC Supply Chain Management, Project Management. Our offer covers a wide range of experience, focused on quality-based drug products process development, manufacturing, validation and troubleshooting, stability strategy and evaluation.

Our CMC Drug Product solutions include preparation and review of regulatory submissions, risk-based strategies for product development, PAI readiness, oversight of Contract Services, supply chain management, project management, and the design, implementation of GMP Systems.

CMC Drug Product Consulting

CMC Regulatory Authoring & Advise

CMC Supply Chain Management

Quality Assurance & Compliance

Supportive services

Project Management
Due Diligence

Difference Matters

provides a strategic approach to regulatory planning and drug product development and manufacturing.

team is an experienced, industry-trained, hands-on group of pharmaceutical development professionals who have been involved with all aspects of CMC clinical and commercial drug development for over 20 years.

is not just a service provider, we function as an extension of your CMC team to help you leverage your company’s expertise and knowledge in a way that is consistent with your corporate objectives.

Solutions

Product analysis, product development plans, and regulatory support

Screening, Selection, qualification, and oversight of product development contractors (CDMO’s, CMO’s, CRO’s etc.)

Oversight and management of Drug Product manufacturing program(s) at CDMO’s and CRO’s

Audits to ensure clinical and late stage manufacturing facilities are regulatory inspection ready

Assessment of the benefit-risk regarding less chemistry, manufacturing, and controls (CMC) information versus patient benefit

CMC Supply Chain Services

CMC Supply Chain Consulting:

Our team of senior pharma supply chain consultants, with experience in building global pharma supply chains and commercial operations, worked in close collaboration with the client to create a customized masterplan for supply chain logistics and distribution of their lead compound. This encompassed the entire value creation chain including drug substance, drug product, transportation, packaging and labelling, serialization requirements and distribution to the end user globally.

Product manufactures need capable oversight and development of clinical and commercial supply chain logistics to ensure a continued supply of goods to the clinic and the market. We provide logistical oversight from the acquisition of raw materials acquisition at the beginning of the process through to delivery of clinical materials to trial sites for developmental programs and distributors for commercial products.

provides that oversight at a point as early as the acquisition of regulatory starting material to delivery of clinical trial material to sites for clinical studies or distributors for commercial products.

can assist with overall strategy, implementation, and on-going supply chain management. Our supply chain experts will guide your company through all business aspects that could impact your supply chain, including vendor selection, manufacturing planning,

raw material sourcing/planning, cost of goods, and inventory planning. will help maintain your clinical trial material to keep your studies running smoothly and prepare you for launch.

Services

End-to-end Supply Chain Assessment and Optimization
CMO/CPO Selection and Management Packaging/ Kit Set-up
Forecasting, Scenario Projections, and Study Dashboard Developments
Inventory and Contingency Strategies
create a comprehensive plan for a global supply chain
provide third-party selections for logistics, distribution and manufacturing

Benefits

Fully Optimized Supply Chain
Reduced Costs Throughout the Supply Chain and to Final Product
Cost Saving by Minimizing Product and Ancillary Expirations
Improved Vendor Quality, Reliability, and Integrity

Clinical Trial Materials Management

CMO management and technical direction oversight
Raw material selection and characterization Pre-formulations (chemical/physical properties testing and evaluations)
Formulations (chemical/physical properties testing and evaluations)
Methods development and validation
Release specifications and testing

Manufacturing and release of clinical batches Packaging and labeling of clinical supplies Container/closure systems testing and evaluations Stability protocols, specifications, tests and results

Quality Assurance & Compliance

Quality Team is focused on providing the highest level of cGMP Quality Assurance for all stages of the drug development lifecycle. Our quality team is made of professionals with years of industry experience, from early development, through commercialization. Our collective experienced spans cGMP compliance for both small and large molecules, as well as medical devices.

With exceptionally strong technical expertise in aseptic processing and sterile products manufacturing, we can provide management of quality investigations, deviations, out-of-specification testing, change control, commercial complaints, and batch record review and release. In addition, can facilitate QA review of CMC documentation including manufacturing process development protocols and validation reports, product specifications, manufacturing master records, and test methods.

QA Services:

Prepare and manage required SOPs for cGMP compliance
Train staff in cGMP policies and compliance
Prepare and execute Quality Agreements with contract manufacturers

CMOs/CDMOs engagement

Serve as the Release Authority on behalf of the client

cGMP Auditing

Assess and consult on level of
compliance of manufacturers
Provide written gap analysis
Propose compliance improvement opportunities

cGMP Remediation Plan & Compliance Improvement:

Kaizen approach to quality improvement programs:

Define required CAPA
Establish missing or incomplete quality systems
Prepare needed SOPs
Train both manufacturing and quality unit staff

Manufacturing Operations:

Review and recommend opportunities for improvement of batch records and other operations documentation to improve shop floor and QA release efficiency.
Advise on suitability of facilities for API, large molecule and sterile product manufacturing to ensure GMP compliance.
Advise on design and operation of environmental monitoring systems for “clean rooms” and other controlled manufacturing facilities.
Provide an organizational strategy for conducting and reporting sterility failure investigations to assess root cause and define corrective action and preventative actions.

Validation:

Help create the critical process parameter analysis experimental plan to be consistent with Quality Design (QbD) concepts
Draft the process validation protocol to be consistent with QbD concepts
Help organize the process validation plan or validation data

Preparation for Agency Inspection (FDA PAI):

Assist in selection of subject matter experts (SME)
Train SMEs on proper procedures for responding to investigator questions
Ensure all previously identified CAPA are complete
Perform final housekeeping inspection to ensure a facility is fully prepared
Organize daily de-briefing and assignment of follow-up duties
Advise on response to all inspection observations

Benefits:

Prevention of Compliance issues
Maintain GMP Compliance
Cost Effectiveness
Efficient preparation for regulatory agency inspection
Post-inspection Rapid Response and Remediation