Biopharma & CMC Consultancy FAQs

Delivering biotech consultants is not the only thing that we do. We are often invited to sit on Boards and Panels, to act as advisors and help commercialise the oppotunities of our clients. Whether it is valuation, due-diligence or establishing exit paths for founders, or acquisition, merger and divestment or licencing through partnerships, we have the experience to help you make better, data-driven decisions.

We also work with VC's and are often asked to safeguard their investments, bringing our market and business understanding to improve the commercial outcomes of all parties. We add credibility to projects securing stronger client outcomes and can bring in financing solutions as needed.

Like the biotech industry, GreyRigge Associates is a truly global consulancy and focuses resources where you need them. If we are not in your precise location, rest assured that our follow-the-sun capability and dextrous use of online collaboration tools means that we are a part of your team quickly and efficiently.

Given the high risks and high costs of biopharmaceutical development, you need the most appropriate expertise that you can find.  We offer that expertise. Furthermore, GRA has global networks that can provide links into academic or industrial capabilities that you’ll likely need.  GRA communicates with clients through a combination of face to face, telephone and online web tools such as Teams, Zoom, Skype & Webex as well as email. We typically use your inhouse collaboration tools to share work and deliver our projects.

GRA successfully works with clients across multiple timezones working with companies across the Americas, on to Europe through to Asia and Australia and repeat, with proven projects including companies such as Takeda, Ipsen Biopharma, Mesoblast, Themis Bioscience, FluGen & Abcam.

Fixed price and time-and-materials cost are the two primary methods for consultancies to price their services.

These each present varying advantages and disadvantages to the client and to the consultant. For where a clear scope of work is provided, a fixed price can be ideal as the client will know what they will be paying and can budget accordingly without worrying that costs will get out of control. However, if the scope of work changes or wasn’t clear from the beginning, then a time-and-materials basis may be more appropriate. With this approach, the client will pay a daily or hourly rate and GRA will send a list of hours worked together with the total fee due. This approach is more flexible with the client 100% confident that they get the solution fully corresponding to their expectations. However, costs must be monitored carefully as they can accumulate over time.

GreyRigge Associates is flexible in its approach to billing. This can be discussed at the beginning of the project to agree what is most appropriate for the client needs.

This is critical. You need the right skills and the right aptitude to fit in with your team and deliver both independently and with the right level of interdependency. We know this and so spend the time matching you with the right associate from GreyRigge. Our senior leadership team, including Dr. Lee Smith and Samantha Dowse will work with you to establish a clear scope of works and understand the exact skill-set that you need. They would then match with our range of Associates and go through an on-boarding exercise to ensure that the resourcing works for us all. Depending on the size of the project, multiple Associates may be involved. 

Building and maintaining your trust in our serivces, company and Associates is of paramount importance to us, especially as your success frequently results in further assignments which reinforce our position as your trusted resource partner. 

Most of Greyrigge Associates consultants have a deep domain experience exceeding 20 years from working in industry. Click through to the 'Associates' tab in the top navivation bar to see our extensive range of associates and their expertise. We have around 1000 man-years of biotech expertise at our disposal. Our founder, Dr. Lee Smith has a Ph.D. and over 25 years experience working in the Biotech industry.  All GRA associates hold a minimum of a Bachelors degree and mostly Ph.D.s, plus many years experience in the industry. We will always discuss with you who would work on your project.  We have proven track records or success as shown in our testimonials on the Home page.  Brief biographies of GRA associates can be found here.

Every client situation is unique. Sometimes, we are the team and sometimes we stand shoulder to shoulder with your inhouse team But to outline a typical approach, then it would include the following steps:

• Initial non-confidential discussion to understand your requirements.
• We put a non-disclosure agreement (NDA) in place so we can talk openly.
• We would discuss over the phone, video or possibly face to face to clarify the details on what you wish to achieve, the timelines that you have and the dynamics of your team.
• We will also discuss the merits of both time-and-materials and fixed cost approaches.
• Once we have a detailed understanding, we will send a proposal covering the scope and fees for the project, plus details regarding the Associates who we feel will add the right value to your project.
• We’ll begin work on your project on the agreed date.
• We will have a clear project target and timescale in mind.  We will have agreed the frequency of online and face to face meetings as the project proceeds together with planned documents and reports.
• A senior member of the Greyrigge Associates team will be on point to manage escalations and change control requests to ensure that our Associates are delivering to requirement.

A CMC (Chemistry, Manufacturing, and Controls) consultant supports pharmaceutical and biotech companies in developing and executing the technical and regulatory strategy for how a medicine is manufactured, tested, and controlled throughout its lifecycle.

Depending on the product’s stage of development, the consultant may support:

• Process & Scale-Up: Process development, manufacturing scale-up, and control strategy.
• Analytical Characterisation: Analytical method development, specifications, bioassay development, and stability programmes.
• CDMO Oversight: Technology transfer, CDMO selection, and ongoing operational oversight.
• Regulatory Authoring: Authoring or reviewing the CMC sections of regulatory applications including INDs, CTAs, IMPDs, BLAs, and MAAs.

The CMC consultant helps connect scientific development, manufacturing, quality, clinical supply, and regulatory teams. By identifying technical, regulatory, and operational risks early, they ensure that the CMC programme is appropriate for the current clinical development phase and capable of supporting later clinical phases and, ultimately, commercialisation.

A bioassay is a test that measures the biological activity of a drug using a biological system, such as biological molecules, cells, tissues, or animals. Unlike biophysical tests that primarily confirm the identity, structure, or purity of the product, bioassays assess whether it produces a relevant biological effect.

Bioassay development is the process of designing, optimising, and validating (in a phase-appropriate manner) an assay so it measures biological activity reliably and reproducibly. Bioassays may be used for product characterisation, comparability studies, stability testing, process development, and lot-release testing.

For biologics—including monoclonal antibodies, vaccines, recombinant proteins, and cell & gene therapies—a potency bioassay is often a critical part of the analytical control strategy. The assay should measure the biological activity relevant to the product’s intended effect and, if possible, link to its mechanism of action (MoA). Bioassay development, as outlined in ICH Q14, typically requires selection of the assay format, optimisation of assay parameters, and formal validation in line with ICH Q2(R2).

QA (Quality Assurance) and QC (Quality Control) are both essential parts of a company's quality system, but they have different functions:

• QA (Process-Oriented): Focuses on the systems and processes used to ensure quality is built into how a product is developed and manufactured. Responsibilities include maintaining the Pharmaceutical Quality System (PQS), approving procedures, reviewing batch documentation, managing deviations and corrective and preventive actions (CAPA), qualifying suppliers, overseeing change control, conducting audits, and monitoring compliance with Good Manufacturing Practice (GMP).
• QC (Product-Oriented): Focuses on evaluating materials and products against predefined quality requirements. Responsibilities include sampling and testing raw materials, in-process samples, drug substance, and drug product, maintaining analytical methods and specifications, stability testing, and investigating atypical or out-of-specification (OOS) results. QC data supports decisions on whether materials are suitable for release.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) apply broadly similar scientific standards to biologics. Both require evidence that a product is consistently manufactured and adequately controlled, and that its quality, safety, and efficacy support its intended use. Both apply International Council for Harmonisation (ICH) guidelines and use the Common Technical Document (CTD) structure for submissions.

However, approval in one market does not automatically satisfy the requirements of the other:

For companies operating across both markets, the practical work is less about reconciling fundamentally different science and more about managing two parallel regulatory relationships, submission formats, jurisdiction-specific requirements, and inspection regimes efficiently.

Working with a Contract Development and Manufacturing Organisation (CDMO) is often critical to a biotech company's development programme. A consultant with experience working with CDMOs provides independent technical, quality, regulatory, and project-management support throughout the relationship.

• Selection & Contracting: Before a CDMO is selected, a consultant helps define the required scope, identify suitable providers, prepare and evaluate Requests for Proposals (RFPs), conduct technical due diligence, assess capabilities and capacity, and review project proposals, high-value contracts, and Quality Technical Agreements (QTAs).
• Governance & Delivery: Once the programme is underway, the consultant helps establish effective governance, performance measures, timelines, budgets, risk registers, and escalation procedures. They represent the client in technical meetings, review development plans, protocols, and reports, oversee technology transfer, challenge scientific conclusions, perform data analysis (including statistical analysis), and ensure conclusions are adequately documented to hold up under regulatory scrutiny.

While the client ultimately remains responsible for ensuring outsourced activities are appropriately defined, controlled, and overseen, a consultant provides the expert guidance needed to manage the CDMO effectively.

A biotech due diligence report is an independent, evidence-based assessment of a company, technology platform, or development-stage asset. It is usually commissioned ahead of an investment, partnership, licensing deal, or acquisition.

While the precise scope may vary, technical due diligence typically covers:

1. Scientific Rationale & Proof of Concept: Mechanism of action, differentiation, and the current stage/quality of preclinical and clinical evidence.
2. Regulatory Path: Reviewing filings to date, agency feedback, and the anticipated path to approval.
3. Intellectual Property (IP): Evaluating IP dependencies, strengths, weaknesses, patent validity, and freedom-to-operate (FTO) assessments (undertaken alongside specialist IP counsel).
4. CMC & Operational Risk: Process robustness, manufacturing readiness, and supply chain continuity.

The goal is to give the commissioning party a clear view of opportunities and risks, enabling them to make an informed decision and negotiate terms that reflect the actual value of the asset.

The core difference lies in the decision the recipient is being asked to make and the scope of the opportunity being assessed:

• Private Equity / Investment Package: Designed to explain how additional capital will create future value. It typically covers the platform technology or product pipeline, scientific and clinical rationale, competitive differentiation, development strategy, key value-creating milestones, funding requirements, use of funds, management experience, and major risks. All claims must be substantiated with evidence that withstands careful scrutiny.
• Company Sale Package: Broader in scope because the entire operating business is being assessed. In addition to scientific and development aspects, it evaluates company assets, IP, contracts, employees, financial position, liabilities, regulatory and quality compliance, CMC capabilities, manufacturing arrangements, supply chain, and operational risks. The supporting data room must provide a complete, consistent record for forensic examination.
• Out-Licensing Asset Package: Focused primarily on a specific product or platform rather than the entire corporate entity. It presents the scientific rationale alongside non-clinical and clinical evidence, competitive positioning, development plans, CMC and regulatory readiness, IP position, third-party obligations, and risk registers.

GLP (Good Laboratory Practice) is a quality system governing how an organisation conducts, monitors, records, reports, and archives non-clinical safety and environmental studies (as described in the UK’s GLP regulations and the FDA’s 21 CFR Part 58 guidance). It ensures that study data submitted to regulatory agencies is reliable, traceable, and repeatable.

GLP covers test facility management, study directors, study personnel, equipment, facilities, protocols, reports, SOPs, raw data, and reference materials.

• When GLP is Required: Safety-critical non-clinical studies supporting human trials—such as toxicology, genotoxicity, reproductive & developmental toxicity, carcinogenicity, local tolerance, and core safety pharmacology studies.
• When GLP is Not Required: Early exploratory research, dose-ranging studies, proof-of-concept (PoC) studies, and preliminary mechanism-of-action (MoA) or efficacy studies used for internal decision-making do not strictly require GLP, though they must still remain scientifically sound and well-documented.

ICH Good Clinical Practice (GCP) is set out in ICH E6(R3) and provides a common international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. The fundamentals—informed consent, independent ethical review, investigator/sponsor oversight, protocol compliance, safety reporting, and data integrity—are broadly aligned across the UK, EU, and US.

The practical execution differs primarily by regional administrative procedures:

• United Kingdom (MHRA): Principles are implemented through the UK Clinical Trials Regulations and supported by MHRA guidance. Clinical trials of Investigational Medicinal Products (IMPs) require regulatory authorisation from the MHRA and positive ethics approval.
• European Union (EMA): Operates under the EU Clinical Trials Regulation (CTR). Trial applications, ethics reviews, scientific assessments, and communications across Member States are managed centrally via the Clinical Trials Information System (CTIS) portal.
• United States (FDA): Adopted alongside applicable 21 CFR regulations. Clinical trials require an Investigational New Drug (IND) application and Institutional Review Board (IRB) approval. An IND takes effect 30 days after receipt by the FDA unless placed on clinical hold.

In summary, a trial across the UK, EU, or US can use a largely common protocol, quality-management system, and GCP framework with no fundamental scientific differences between agency approaches. The practical differences are procedural and administrative rather than scientific.

Yes. We are successful for clients (see testimonials & case studies) and work to ensure that your project is successful. Our reputation is paramount and we can only protect it by being successful for our clients. In addition, your time is too valuable. You may waste time and money trying to learn an activity and it still may have problems. This is why professional help is so important in that it helps you save time and money and achieve the job at the first attempt.