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Biologics
Biosimilars
can support drug product (DP) development services for biologics, vaccines and parenterals. Our DP development team specializes in the development of clinical and commercial drug product formulations and processes. We have extensive knowledge and experience with the development of liquid, frozen, and lyophlized dosage forms and we also have extensive experience with multiple container closure systems (CCS) that include vials and combination products such as pre-filled syringes (PFS), PFS with needle safety devices (NSD) and autoinjectors (AI). Drug Product Team has helped author regulatory submissions in the US as well as in the EU and has worked extensively with international vendors. They have extensive experience in program management, scale-up, tech transfer and validation, lean manufacturing, six sigma/process excellence, design of experiments (DOE), chemistry manufacturing and controls (CMC) regulatory submission authoring, capital projects and third-party manufacturing management.CMC is an acronym for chemistry, manufacturing, and controls which are crucial activities when developing new pharmaceutical products. Essentially to appropriately manufacture a pharmaceutical or biologic specific manufacturing processes, product characteristics, and product testing must be defined in order to ensure that the product is safe, effective and consistent between batches. These activities are known as CMC, chemistry, manufacturing and control. CMC begins after a lead compound is identified through drug discovery and continues through all stages of the drug development cycle and ensures quality and consistency during the manufacturing of the pharmaceutical product. In addition to the pharmaceutical product, CMC also applies to the facility where it manufacturing occurs.
CMC is a critical component that cannot be overlooked. It ensures that the drug product has a consistent formula so that the drug used in clinical trials is the same as what is made commercially available. Because CMC applies to all stages of pharmaceutical development and focuses on creating consistency in drug product stability, release, and manufacturing, it must comply with FDA guidance. Without CMC, the product would be deemed unsafe and approval would be impossible.
Before you’re ready to test your medicinal product on humans, you must develop a CMC process to ensure quality manufacturing standards have been established. This information is required in Module 3 of the clinical trials application (CTA), such as the investigational medicinal product dossier (IMPD) in Europe and the Food and Drug Administration’s (FDA’s) investigational new drug (IND) application in the US, as well as EU marketing authorization applications and FDA new drug applications (NDAs) or biologics license applications (BLAs).
The primary objective of CMC is to assure the quality of the finished product during all phases of development. Regulatory authorities need to see detailed standards to ensure consistency of identity, safety, quality, stability, and strength between the product used for clinical trials and product batches produced for commercial purposes on an ongoing basis.
All companies with investigational products are required to follow the specific details of their CMC process for every phase of the product lifecycle, including lifecycle management activities, eg, technology transfer and line extensions. A critical element is knowing which steps and variables in the manufacturing process need to be controlled and why in order to obtain a comprehensive understanding of the necessary CMC strategy.
Consequences of CMC Regulatory Non-Compliance
If CMC practices are not followed or if they do not meet current regulatory FDA regulatory requirements, the marketing authorization will be considered non-compliant and will be withdrawn. The consequences of this include fines, suspension of distribution, and any data gaps will have to be addressed under scrutiny of the appropriate regulatory agencies.
FDA regulatory requirements are constantly evolving, so you’ll need to update your CMC strategy to stay compliant with current guidances from the agency.
At our main goal is to help our clients develop new and better drug formulations, transforming innovative ideas into approved products. Our team possesses decades of experience in biopharmaceutical industry and have extensive CMC knowledge and experience in the development and manufacturing of traditional and complex dosage form drug products. We have prepared CMC sections for numerous of IND applications and are skilled in authoring and reviewing CMC Module 3 regulatory sections required to initiate human clinical trials.
LLC
P.O. Box 8053
early involvement in the drug development process saves you substantial time and money further down the road. extensive experience with drug product CDMOs globally allows you to gain insight into the workings of vendors as well as a collaborator in ensuring your compliance manufacturing needs are met on time.
can lead process improvement or remediation efforts including FMEA, Risk Assessments, CAPA remediation, improving process capability, statistical analysis with your chosen vendor.
We offer “person in plant” services to monitor critical experiments or manufacturing operations. This can also prove to be a valuable part of any firm’s due diligence efforts in assessing facility and process assets.
We can apply our significant experience working with CMO’s and CDMO’s to source a vendor who fits best for you to help ensure they meet deliverables, value and quality expectations.
has extensive experience managing these activities ensures the quality of the materials being produced and the reliability of the clinical and commercial supply chain as it moves from bench-top through scale-up.
Drug Product Development
Our drug product team has wide experience in formulation process development, scale-up, and commercialization of sterile products.
Selecting and efficiently managing vendors that are reliable, as well as technically competent, is one of the best tools available for minimizing the time needed to develop and register a drug or healthcare product. Contract manufacturers, laboratories, and suppliers require diligent oversight and management so as to prevent development delays and cost overruns and to ensure the quality of products and deliverables. We work with vendors and clients to identify appropriate and place the required management processes to minimize the risks and maximize the value that these service providers can produce.
knowledge and network of contract manufacturing organizations (CMOs) allows us to identify the most suitable service providers for your compound and dosage form and ensure optimal performance within your time and budget parameters.
The chemistry, manufacturing and controls (CMC) experts at provide CMC consulting services that yield efficient regulatory approaches to pharmaceutical and biologics. We partner with you to develop your regulatory strategy, as well as author, prepare, review and submit CMC documentation for all phases of development.
can piece together the CMC documents and data from your development program to tell the story of how the product was developed into a coherent Pharmaceutical Development report. This will be invaluable during pre-approval inspections and when drafting CMC sections of filings for marketing
Our CMC experts have experience with complete analytical and formulation development programs, from initial development to production of clinical and commercial supplies for large molecules.
early involvement in the CMC drug development process saves you substantial time and money. From API and formulation sourcing, to manufacturing, scale-up and packaging, we provide invaluable strategic guidance and management services.
By remaining current with the regulatory landscape, we can save time and money by ensuring your development program is meeting the latest expectations. This includes recent regulatory requirements addressing supply chain risk for adulterated raw materials (melamine, nitrosamine, BSE, TSE) and serialization of packaging.
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
Benefits
Clinical Trial Materials Management
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 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:
CMOs/CDMOs engagement
cGMP Auditing
cGMP Remediation Plan & Compliance Improvement:
Kaizen approach to quality improvement programs:
Manufacturing Operations:
Validation:
Preparation for Agency Inspection (FDA PAI):
Benefits:
Industry Project Management Services
In Depth Knowledge of Drug Development and Manufacturing
Services PM’s consultants are experienced pharmaceutical professionals that have led teams of experienced SMEs through all stages of the drug product development process to commercialization.
offers strategic and tactical regulatory expertise in all phases of drug product development through commercialization. Our experts leverage their comprehensive experience to strategically position and guide clients through a streamlined and customized approach that helps them achieve their drug development goals.
project management services include:
Strategic drug Product development assessment and planning
offers strategic and tactical product development expertise at all stages of drug development. We provide product development advice and tactical guidance grounded in decades of experience
