SERVICES Chemistry, Manufacturing, and Controls (CMC)

Need expert help navigating regulatory, scientific, and technical challenges to ensure compliance, bolster your production capability, and guarantee timely delivery? We help you achieve your next milestone by offering our expertise in all aspects of CMC development, including product, process and test method development, product stability testing, phase-appropriate validation, packaging development, and manufacturing and testing under GMP conditions.

Contact us » Engagement models »

Access the full range of technical and regulatory CMC proficiencies and capabilities

Addressing the multifaceted challenges of  CMC requires comprehensive expertise and a coordinated approach. Our diverse, global team of CMC experts manages all technical and regulatory aspects of development, considering both FDA and European Health Authority guidelines.

Catering to (bio)pharma businesses of all sizes, we integrate with your team to facilitate product, process, and method development. Responsive and adaptable, we operate at the intersection of regulatory, scientific, and technical challenges, ensuring open communication with all stakeholders. 

We react promptly and flexibly to your needs, acting as a high-quality extension of your team. Talk to us when you want to ensure efficiency, compliance, and success throughout your entire development journey.

Contact us »

FUNCTIONAL AREA CMC Strategy Development and Management

  • Formulating CMC development strategy

  • Overseeing CMC Project Management

  • Preparing for agency meetings and responding to questions

  • Conducting technical CMC due diligence and gap analyses

  • Assisting with CDMO selection and management

  • Process Optimization

  • Performing GMP Audits and inspection readiness assessments

  • Providing Quality-by-Design (QbD) support, including Risk Assessments and Design-of-Experience (DoE) study design

Functional Area Drug Substance Process Development

  • Developing drug substance formulation

  • Designing manufacturing processes

  • Planning stability studies
  • Writing and reviewing documentation

FUNCTIONAL AREA Drug Product Formulation and Process Development

  • Conducting API-excipient compatibility studies and designing early-phase, "fit for purpose" formulations
  • Formulating parenterals, oral solid dosage forms, and lyophilized products
  • Developing immediate, delayed, and prolonged release formulations
  • Designing and validating processes
  • Structuring stability studies
  • Writing and reviewing documentation
  • Selecting packaging, including combination medical devices

FUNCTIONAL AREA Analytical Development

  • Selecting methods, developing, qualifying and validating methods, and conducting method transfers
  • Designing and evaluating product stability studies
  • Designing and assessing method qualification, validation, and transfer studies
  • Designing comparability studies
  • Setting product specifications
  • Writing and reviewing documentation

FUNCTIONAL AREA CMC Regulatory Support

  • Advising on regulatory strategy for CMC
  • Preparing and reviewing CMC sections of regulatory submissions
  • Helping with post-approval changes and lifecycle management
  • Providing guidance on global CMC regulatory requirements

FUNCTIONAL AREA Biologics Development

  • Designing, developing, and validating processes for biologics
  • Providing expertise in cell culture, purification, and formulation
  • Planning and conducting biologic stability studies
  • Providing support for biosimilar development

FUNCTIONAL AREA Supply Chain Management

  • Developing strategies for raw material sourcing and management
  • Assisting in technology transfer and scale-up activities
  • Managing relationships with CMOs and third-party logistics providers
  • Addressing issues related to the import/export of pharmaceutical products

FUNCTIONAL AREA Quality Assurance and Control

  • Designing and implementing QMS
  • Conducting internal and supplier audits
  • Assisting in the preparation and response to regulatory inspections
  • Performing product quality reviews and trend analyses

FUNCTIONAL AREA Manufacturing Process Optimization and Technology Transfer

  • Improving manufacturing processes for efficiency and cost-effectiveness
  • Assisting with the transfer of technology from development to commercial manufacturing
  • Developing and implementing process control strategies
  • Providing support for process validation activities

Need CMC support in other functional areas? Contact us.

We understand the unique CMC needs of (bio)pharma companies can often extend beyond the usual functional areas. The areas of expertise highlighted above form the core of our CMC support services. However, they don't define the limit of our capabilities.

If you require specialized CMC support in areas not explicitly listed above, we encourage you to reach out. Our seasoned team of experts is well-equipped to understand and address a wide spectrum of CMC-related activities and tasks.

Contact us »

Engagement Models


Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.

ENGAGEMENT MODEL Consulting Projects

Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.

Contact us » Learn more »

ENGAGEMENT MODEL Staff Augmentation

Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

Contact us » Learn more »

Engagement Model FTE Recruitment

We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.

Contact us » Learn more »

Why work with The FDA Group?

  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

Read our brochure »

Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management For Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of CMC requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific resourcing needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.