CMC consulting services

Whether you're developing an oral small molecule, an autologous cell therapy, or anything in between, our CMC experts can support your pipeline in the US and Europe. Each of our consultants brings significant industry experience and specialized knowledge across a range of therapeutic modalities, disease areas, and geographies. This allows us to build projects teams that match the precise CMC needs of each client. Sound CMC strategy and execution frequently results in time and financial resource savings by heading off possible challenges early in product development. Additionally, our CMC experts often work in an integrated fashion with other disciplines on broader consulting projects, helping to ensure an aligned path forward for our clients.

Our CMC capabilities:

  • Pharmaceutical development strategy 
  • CMC regulatory support (IND, NDA/BLA, agency interactions)
  • Quality management systems
  • cGXP compliance audits and preapproval inspections
  • CMC due diligence for BD transactions
  • Upstream supply chain planning and implementation
  • Downstream supply chain and related distribution licensing & GDP requirements


Pharmaceutical development strategy

Alacrita provides technical and regulatory strategic planning support through the various stages of a product's pharmaceutical development, applying "quality by design" principles and helping clients get the most from their CMO/CDMO/CPO relationships. Our experts can help ensure the manufacturing process is optimized and development moves efficiently forward towards regulatory submission with a product of consistent quality and performance.

CMC regulatory support


Our CMC consultants are experts in the FDA/EMA regulations that pertain to CMC, including the additional complexities biologics and cell and gene therapies present, such as with manufacturing process optimization. Our team can provide high-level reviews to help uncover any potential regulatory issues, review and/or prepare regulatory submission packages, and assist with interactions with regulatory bodies, in the US, Europe, and other territories.

Within our network are CMC professionals with advanced expertise in many therapeutic areas and disease indications, allowing us to provide experts with the exact regulatory experience our clients seek. This has proven to be critical, especially with engagements involving autologous products, which may change meaningfully from the time their IND is first granted.

Quality management systems and cGXP compliance/audits


Alacrita QA experts can help you develop an effective quality management system and prepare your facilities for cGMP inspection, both with the FDA and EMA. We also conduct compliance audits of manufacturing facilities and have consultants available for in-person plant visits. 

CMC due diligence


Alacrita frequently provides CMC due diligence to support business development activities, including technical review of CMC-related program documentation, to ensure that prospective licensees and investors are aware of any issues that may affect a transaction. If an issue is uncovered during a DD exercise, we typically provide risk mitigation strategies. (Information on on our BD services can be found here.)

Upstream & downstream supply chain consulting


As a component of commercial launch planning activities, Alacrita consultants help our clients get their product to customers in key geographic markets, by providing expertise in strategic and tactical design, as well as the legal, financial and practical setup, of pharmaceutical supply chains. Our experts will help you build a patient-oriented supply chain that balances the needs of the patient, the providers, the market and the company, in compliance of local regulations. 


The below case studies can help illustrate the CMC expertise we frequently provide to clients:

Case Study: CMC support for discovery stage microbiome company


Challenge: For a discovery stage microbiome company, Alacrita supplied a senior biologics manufacturing specialist to act as Interim VP CMC.

Solution: Our consultant set up the initial CMC activities including processes for fermentation, harvesting and cryo-preservation for live biotherapeutic cultures, put in place quality systems and recruited the initial CMC team

Case Study: Gene therapy preclinical, CMC, and regulatory strategy


Challenge: An early-stage biotechnology startup company reached out to Alacrita for critical support of its two lead AAV-delivered gene therapy programs. As a virtual company, the client needed expert analysis of ongoing experimental research and development planning of future preclinical PoC studies conducted by CROs and academic collaborators. The client also requested support for planning CMC and regulatory activities needed to progress these programs to IND.

Solution: We prepared a team of Alacrita consultants specializing in gene therapy, regulatory, and CMC and provided the client with ongoing technical data review, analysis, and preclinical development recommendations for both gene therapy programs. This included the below:
  • identification, timing, and design of preclinical animal model studies (mice, NHPs, etc)
  • efficacy, biodistribution, safety, and toxicology studies
  • identification of risk factors and mitigation strategies; research timelines with go/no-go decision points
  • coordination of studies with CROs and academic collaborators to drive completion of translational studies
  • presentations of scientific data to potential investors

Alacrita's CMC and regulatory experts also assembled a CMC and regulatory roadmap for the client’s two gene therapy programs through preclinical development and into clinical development. The roadmaps highlighted exactly what needed to be done for each program, in what sequence, to allow success at key milestones.

Case Study: Assessment of European manufacturing plants acquisition


Challenge:
A US-based CDMO was in an acquisition process for two manufacturing plants in Europe during the COVID-19 pandemic. As travel was impossible, the client needed to hire local expert consultants who could integrate with the client due diligence team and also conduct the assessment on the ground. The principal requirements were:

  • Evaluate Operations/QA risk to maintain continuity of supply
  • Identify strategic opportunities to develop synergies/efficiencies to capture growth and improve margin
  • Develop an integration plan (Organizational, IT, QA Governance, Strategic Projects)

Solution: One of Alacrita’s CMC consultants worked collaboratively with the client and dovetailed into the broader multidisciplinary project team to accomplish the requirements above. Unfortunately, as the COVID crisis deepened, it was not ultimately possible to conduct an on-site audit of the plants, but a remote audit and interviews with key staff were completed, which were sufficient for the client's needs.

Case Study: Regulatory, QA and supply chain blueprints for a US & EU product launch


Challenge: Alacrita was engaged by a biopharma company developing a therapeutic for a severe orphan disorder. With both a Breakthrough status designation from the FDA and an EMA Prime designation, the company was preparing for commercialization in both the US and Europe and needed a fully integrated plan taking into account tax, regulatory, legal and supply chain needs. Additionally, in order to align the launch on a global basis and ensure successful launches in both the US and Europe, the company also wanted the supply chain outlined in the context of their planned US organizational structure.

Solution: Alacrita delivered blueprints for a US and an EU organization to define and integrate the commercial, operational and supply chain structure with considerations for tax optimization, regulatory compliance, quality systems and SOPs and HR/legal considerations, including the below items:

  • Regulatory: Review of regulatory environment on a country by country basis, to verify personnel required, licenses required and systems mandated on a country level. This was done through local regulatory consultants in Alacrita’s network.

  • Quality Systems: A top-line definition of the SOPs and quality agreements needed were evaluated and outlined on a EMA level, as well as for the US.

  • Supply Chain: Using the input from regulatory, tax, quality and license modules of the project, we outlined a supply chain to ensure 24-hour delivery to all centers and to optimize product and financial flow for the biopharma company. An evaluation of the USA supply chain needs was conducted through analysis of the centers to be reached, the manufacturing and secondary packaging site locations and the required product and financial flows.


Case Study: CMC consulting for a company developing a peptide


Challenge: A small biotech company was developing a peptide and needed support in taking the compound to first-in-man studies and Phase II clinical trials. This was the first time the company had taken on a venture of this kind.

Solution: Our CMC consultant joined the virtual team responsible for taking the compound to first-in-man studies. Our support included:

  • Advising on drug substance manufacture, characterization and salt selection, developing analytical methods and stability testing.
  • Helping resolve a number of development issues identified for the drug substance.
  • recommending and assessing appropriate chief research and marketing officers for CMC activities including development of assays and stability testing, and reviewing and negotiating contracts and technical agreements.
  • Creating a formulation strategy for Phase I trials and design of the formulation.
  • Providing CMC advice and attending two scientific meetings with the MHRA (Medicines and Healthcare Regulatory Agency).
  • Helping establish the documentation systems required for both quality and future due diligence.
  • Providing guidance on the specifications for drug substance and product.
  • Compiling CMC data for the IMPD  (Investigational Medicinal Product Dossier), which was approved with no questions raised.
  • CMC planning for Phase II studies.

On the strength of our support, the client retained our CMC consultant for a second development venture, providing similar support in developing a new IV injectable formulation.