Chemistry, Manufacturing and Controls (CMC)
CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.
Our CMC services include:
Our Chemistry, Manufacturing and Controls (CMC) team can provide you with regulatory strategy advice, scientific/technical writing and quality variation/amendment/supplement submission management on a global basis. We cover all CMC regulatory tasks from early development to authoring of the marketing authorization application dossier and beyond. We can give you regulatory guidance in dossier format, setting specifications, method development and validation documentation adapted to any type of medicinal product or drug substance/API and to any region worldwide. Whether it is a case of first-time submission, change control or maintenance throughout the product lifecycle, our multi-disciplinary team delivers CMC service that is aligned with the needs of your global submission management department, manufacturing sites and other stakeholders and that, of course, meets the latest Health Authority requirements.
Our services include:
- Product scope includes human and veterinary medicinal products comprising all types of APIs (chemicals, biologicals, biosimilars, herbals and homeopathics)
- Strategic consultancy during pharmaceutical development and lifecycle management
- Regulatory CMC intelligence and data management
- CMC scientific and technical writing
- Compilation of quality dossiers (ICH and non-ICH)
- CTD modules 3 and 2.3
- IMPD, IND
- ASMF / DMF, CEP
- Normative document
- CMC maintenance support: change control and quality variations
- GxP services (GMP, GACP, GDP) including audits
Biopharmaceuticals are an unprecedented success story. Due to their outstanding efficacy and safety and their high potential to address unmet medical needs, biopharmaceuticals are by far the fastest-growing part of the industry and are already making up 20 percent of the global pharma market.
But the effort and amount of technological skills required for the development and production of these complex molecules are both challenging and evolving rapidly, and so are the associated expectations of the regulators. Therefore, it is essential to account for regulatory requirements early on in development and to carve out the most efficient path to approval to ensure commercial success.
Based on a broad global project experience, we at PharmaLex recommend an integrated solution combining our scientific, technological and regulatory expertise to meet your specific support needs, both for specific aspects or for the complete development process.
The product types we support include:
- Recombinant proteins (e.g. mAbs (and derivatives), hormones, enzymes, fusion proteins)
- Tissue, cell and gene therapy products / ATMPs
- (Non-recombinant) biologicals isolated from living sources
- Antibody drug conjugates (ADC)
- Vaccines (recombinant proteins, live attenuates and recombinant vector vaccines)
Our services include:
- Development and regulatory strategy considering regional requirements (e.g. US, EU, Canada, Japan, Emerging Markets)
- Gap analysis / Due diligence
- Scientific and technical writing and compilation of regulatory documents
- Scientific advice and other Health Agency meetings
- Risk assessment
- Preparation of Target Product Profile (TPP)
- Comparability exercises
- General ‘troubleshooting’, including investigations and root cause analysis and support for CAPA
- Deviation and change control preparation / review
- Method / process validation
- Process characterization
- Project management
Chemistry Manufacturing and Controls (CMC) compliance is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors, including Merger and Acquisition (M&A) programs, increasingly complicated networks of internal and external manufacturing sites and insufficiently robust internal processes within an organization to manage complexity and cross-functional interfaces.
These factors often lead to compliance issues, which may have serious consequences from a delay in product approval requiring corrective actions up to product recalls and the loss of marketing authorizations. It is clear that the impact of non-compliances identified through Health Authority inspections can be extremely costly and can irrevocably damage a company’s reputation.
A strong partnership is required between the Regulatory and Quality functions with the necessary inputs to support the implementation of transformed systems and processes within an organization, which can ultimately provide a sustained CMC compliance outcome for a business.
Our team of CMC and Quality experts will help you make your compliance proactive and in line with Health Agencies’ requirements, supporting the uninterrupted supply of medicines to patients. Besides broad experience, we bring a standardized approach and ready-to-use templates for compliance gap analysis and remediation to the table. And we can provide the needed resources to manage such projects even under high time constraints.
Our services include:
- CMC Due diligence (e.g. in-licensing activities) / Gap analysis
- Product / patient impact assessment
- Development and implementation of risk-based gap remediation plan
- Root Cause Analysis of gaps in CMC information
- Preparation for regulatory health authority inspection (incl. CAPA-management)
- Optimization of the supply chain
25+ years of experience in global regulatory maintenance support and CMC
125+ CMC experts worldwide
750+ quality overall summary expert reports prepared
Proven track record with 7500 successfully completed projects
What our clients say
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
VP Regulatory Strategy
During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.
VP Regulatory Affairs