Drug Manufacturing & QA

Project management and QA expertise is critical to support manufacture of GMP batches for clinical trials.

We have the expertise to support drug manufacturing and quality assurance activities required to take your product from pilot scale of the API to preparation to GMP batches of drug product for your clinical trial. We integrate these activities into the overall Strategic Development Plan at the appropriate stage. You don’t want to be spending money earlier than necessary, but you also don’t want manufacturing to be lagging behind when you are ready to enter the clinic!


To move your drug from pilot scale to GMP batches you need an experienced team.


B4D has provided project management support for GMP manufacturing of API and drug products and associated analytical testing. We have worked with biologics, targeted therapies, peptides, drug conjugates, small molecules, cellular therapies and new formulations of existing drugs including oral, parenteral and topical.


B4D connects to a network of QA experts to bring in the right experts at the right time, based on the needs of the product. B4D has successfully developed quality systems for a number of early stage companies to ensure GMP compliance.


We have a proven track record of successful regulatory filings for drug manufacturing projects we have managed. We have an in-depth understanding of what needs to be done to support and IND/CTA submissions and the experience to save our clients from expenditures that can wait until a later stage in the drug development process.

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Service 3: Drug

Early stage companies may not have the QA systems in place needed to meet GMP requirements. We work with you to develop a complete set of SOPs tailored to your company to ensure regulatory compliance as the project moves forward.

Finding the right manufacturing contract manufacturing organization (CMO) for the project is key. The process starts with obtaining proposals from the most suitable CMOs based on experience and reputation – pricing is not the only consideration.

Initial supplier qualification can be based on self-assessments by the CMOs but we ensure that Quality agreements are established and site audits are performed prior to GMP manufacture.

B4D has the experience to manage issues that inevitably arise along the way. We work with chemistry, manufacturing and analytical experts and quality consultants to oversee work conducted at CMOs. Our team provides cross-functional project management support using online collaboration tools for timelines and virtual meetings to keep on top of action items and minimize delays.

We establish virtual data rooms and tracking systems for the numerous project-associated controlled documents – including analytical protocols, reports, SOPs, specifications, certificates of analysis, tech transfer reports, master batch records for engineering and GMP runs, and stability protocols and reports. We also provide critical quality input and expert reviews into these documents as needed.

Virtual Company Management

The B4D management team solution.

The B4D virtual management team provides the level of expertise and experience that investors will want to have in place prior to financing. Our team has the skill set to either take over all senior management functions or “gap-fill” roles to complement your existing team.


Our management team will navigate the path to your company’s goals.


B4D has set up and run several virtual biotech companies. We have worked, with equal success, as the entire senior management team reporting to the Board of Directors, or gap-filling to complement the existing management.


B4D has experience developing and managing financial plans and budgets that exceed the expectations of potential partners as well as our clients. We have templates and processes in place to ensure nothing is missed and everything is closely monitored.


B4D provides a flexible cross-functional senior management team, eliminating the need to hire multiple functional positions. This model overcomes the excessive burn rates experienced by traditional biopharma companies associated with expenditures unrelated to actual asset development.

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Service 6: Virtual

Our team will put in place company-specific administrative systems and SOPs that are needed to run a company efficiently. This includes establishing regular project and Senior management team meetings and reporting procedures to track both project progress and spending against approved budgets.

We provide management support for preclinical to clinical, chemistry and manufacturing, analytical, clinical, business development and licensing teams, whether in-house or external.

We have experience both as Board members and as management reporting to Boards and know what type of information they need to carry out their oversight function. We can prepare presentations for quarterly meetings along with written progress reports and develop Excel-based financial plans and budgets.

One of the challenges a start-up biotech company faces is to select the right contract research or manufacturing organizations (CROs/CMOs) for their specific project. There are so many to choose from and cost is not the only factor to consider. B4D has worked with many CROs/CMOs and can help you identify the most appropriate supplier for your project, obtain competitive bids, negotiate contracts and oversee work conducted at the company to ensure the project stays on track and on budget.

B4D can set up a virtual data room for your company, providing the ability to keep your information confidential but readily available to potential licensing partners and investors, as well as the appropriate company team members and consultants.

Business Development & Licensing

A clear commercialization strategy is essential.

Early-stage biopharma companies may be highly skilled at presenting the scientific merits around their novel discovery but investors also need to clearly understand how this translates to commercial potential for the product and their opportunity for an exit. A clear licensing/ commercialization strategy will help attract the right investors and ensure the required level of funding is available to support the transition from preclinical to clinical.


A track record of successful licensing and financing transactions.


B4D has a track record of concluding licensing deals in the biotech and pharma world including co-development, co-marketing, tech transfer, early stage, late stage and marketed product agreements. We are experts in deal structure and knowledgeable in comparative deal terms and negotiations.


B4D has written grants, found seed money, introduced clients to investors/venture capitalists and presented at financing conferences globally. We have contacts within the local, provincial, national, and international financial circles.


With an established network of contacts, B4D can search for partners more cost-effectively. As B4D has often met contacts in person before, a virtual meeting model becomes even more efficient.

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Service 5: Business

B4D will develop a licensing strategy that identifies the highest value inflection point for your project and optimal timing for out-licensing. We develop risk-adjusted project valuations and find deal comparables. Based on our industry experience we can advise on which potential partners to approach and the key data they will want to see.

Initial planning includes identifying potential partners through our industry network. Cost effective means such as licensing meetings can help build rapport with potential partners and anticipation for the product. Details about any licensing information can be broadcast in various ways, raising awareness without divulging confidential information. Once confidentiality agreements are in place, the selected partners are kept informed about milestone development events such as IND approvals and positive clinical data.

B4D has a network of financing contacts and can help identify appropriate sources of funding for your project – for example seed financing from non-dilutive government grants or equity-based venture capital financing. We monitor new funding opportunities and can match companies with sources most likely to succeed.

B4D has a network of financing contacts and can help identify appropriate sources of funding for your project – for example seed financing from non-dilutive government grants or equity-based venture capital financing. We monitor new funding opportunities and can match companies with sources most likely to succeed.

We work with you to ensure your financing and licensing presentations include the key elements investors need to make a decision. We know which partnering meetings yield the best results and can attend meetings and present for your company or as a part of your team.

Regulatory Strategy

An effective regulatory strategy is key to market approval.

One of the most overlooked aspects of product development is ensuring you have a viable regulatory strategy. Guidelines and regulations in different countries are continually changing. Keeping up to date and developing a plan of action based on the most recent regulatory precedent maximizes your chances of regulatory approval and ensures you do not miss an opportunity to streamline your development by taking advantage of the select programs offered by the different regulatory bodies.


Experience is everything when it comes to regulatory success.


B4D has experience in all major regulatory jurisdictions (Canada, US, Europe) and has had continuous success with meetings and submissions to the various branches of the different agencies in those countries.


We provide all the necessary regulatory templates and experience preparing the components required for regulatory filings in the different jurisdictions.


B4D has established a network of experienced experts in CMC, quality, toxicology, clinical and statistics who can be utilized as needed for input into submissions or in assisting in negotiations with regulatory authorities.

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Service 4: Regulatory

The first step is to identify the most effective regulatory pathway based on your product and chosen indication. We will identify the major market countries where approval will be beneficial to your marketing or licensing strategy. We will identify any expedite programs or regulatory incentives that may apply and carve out the best regulatory pathway based on your product’s stage of development and current funding.

We will address which regulatory authority might be best to seek guidance from first and at what stage in the development process would be most beneficial for a Pre-IND or Pre-CTA meeting. We will also plan subsequent interactions with the select authority and when it would be most advantageous to approach multiple regulatory jurisdictions. Our team can work with you to approach the selected regulatory authority for consultation on your product development strategy early on. This usually takes the form of a Pre-IND or Pre-CTA meeting request.

By analyzing both market approvals and the development landscape for your chosen indication, our team will use the most recent regulatory precedents in developing a regulatory strategy that has proven success while incorporating any unique advantages that may be inherent in your product.

Our team can write the documents that are required for the submission of the Pre-IND or Pre-CTA meeting requests as well as the IND and CTA submissions themselves. We will work with you to create the dossiers necessary for regulatory submission and ensure that all supporting documentation such as preclinical reports, CMC documents, investigator brochures and protocols meet regulatory quality standards.

As the development of your product progresses, we will ensure that regulatory milestones are aligned with the completion of significant development milestones. This will ensure that the regulatory authorities are kept current on your development’s progress and will make sure to take advantage of all available avenues of dialogue with the authorities.

Preclinical to Clinical

Choosing the right model can provide an early signal to certain product attributes and adverse effects before proceeding to human studies.

B4D will guide you through the challenges of taking your product from preclinical through to your first in human study. The preclinical development of a product often starts in academia with early proof-of concept. Nonclinical studies should be designed to build toward the starting dose and regimen for the first-in-human (FIH) clinical study. The FIH clinical study is designed to maximize information both on the safety and the action of the drug. For this reason, FIH studies are ideally conducted in a population that expresses the drug target.


The first in human clinical study can make or break a company.


B4D has extensive experience in several therapeutic areas such as cancer, immunology, endocrinology and women’s health, to name a few. We have worked with both small molecules and biologics including cell therapies and drug conjugates, as well as many different formulations such as oral, parenteral and topical.


B4D has years of experience writing preclinical and clinical study protocols, reports and associated publications. We have document templates and expertise in developing company-specific GCP-related SOPs and all the requisite documents necessary for the conduct of the clinical study including the investigator’s brochure.


B4D has an established network of experienced experts (scientists, toxicologists, statisticians, clinicians, etc.) with whom we have worked on many previous projects, to obtain input into all aspects of development from preclinical to clinical study conduct.

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Service 2: Preclinical

The first step is to identify the target indication based on the assumed mechanism of action of your product and then select the appropriate preclinical disease models. B4D will ascertain which disease models are favoured by both clinical experts and regulatory authorities and work with academic experts or CROs to conduct these experiments in validated models. B4D will assist in the design of the protocols ensuring that each study is maximized to provide information on effects on biomarkers, clinical indicators, safety, pharmacokinetics and dosing. While there is not a requirement for conduct under GLP at this stage, B4D will assure GLP-like conduct of these studies and the issuance of IND quality final reports.

Based on the type of product and the selected indication, B4D will work with toxicology experts with the required experience to develop a nonclinical program of studies to support the FIH clinical trial. Where possible, study elements will be combined to maximize the information obtained from a single study. B4D will identify qualified CROs to conduct these studies under GLP and can organize audits of the selected facilities. B4D will also map out the nonclinical requirements at each stage of clinical development to ensure you are prepared for each step in your regulatory filing without incurring large financial commitments in the early stages of clinical development.

In designing the first study B4D will consider both the competitive and regulatory landscape and include not only evaluations of safety and dose-finding but endpoints which provide proof of concept for target engagement. This provides the necessary information for determining the design and sample size of subsequent studies as well as support fundraising efforts. B4D will assemble a Clinical Advisory Board (CAB) consisting of clinical experts in the indicated therapeutic area to develop this novel FIH protocol. B4D will refine the protocol by engaging regulatory authorities in Pre-IND/CTA meetings prior to filing the IND/CTA.

Following regulatory approval, B4D can assist in all or select aspects of clinical operations to ensure the conduct of the clinical study adheres to the principles of Good Clinical Practice (GCP). B4D can identify qualified vendors through an RFP process and ensure the CRO selected is the best qualified for the study. Having previously worked in the therapeutic area, B4D can identify clinical trial sites through our network and work with the CRO on management of the sites throughout the conduct of the study. B4D also has preferred data management groups for all aspects of statistical analysis and data collection and management of clinical trial information. We also work with pharmacovigilance groups for the management and reporting of SAEs that may arise during the study. Throughout the process, B4D will use online management tools to ensure development milestones are met so that costly delays are not incurred at this vital stage of the product development process.

In addition to protocol writing, at the completion of the clinical trial and following the analysis of the data, B4D can produce the Final Study Report and also assist in the writing and submission of publications to targeted journals based on the study results.

Strategic Development Plan

More than just a drug development plan.

It is within the Strategic Development Plan that the details of your novel discovery, current project status, target market, development plan and costs coalesce into one document, which captures the excitement and commercial potential of the product.


Success starts with a great plan and an experienced team to implement it.

Experience at all stages

The team members have 30+ years experience working with projects from discovery through preclinical and clinical to regulatory approval and have out-licensed products at both early and later stages of development.

Major Therapeutic Areas

We have experience in a broad range of therapeutic areas including cancer, immunology/inflammation and orphan indications, in selecting lead indications, mapping out overall development programs as well as designing individual clinical trials.

Templates & Tools

B4D has developed a customizable Strategic Development Plan template for its clients. For project management we have successfully used online collaboration tools for timelines and virtual meetings supplemented by management reports to keep on top of action items and minimize delays.

B4D Solutions

Service 1: Strategic

B4D’s Strategic Development Plan summarizes the current stage of your program and outlines the regulatory pathway, clinical and product development timelines and cost estimates to approval in the selected indication. B4D consultants review all available data on your product and assess the competitive landscape and clinical/regulatory environment to help you better understand the commercial potential of your product and the challenges that lie ahead.

The plan includes appropriate therapeutic area information and summarizes completed and planned preclinical, clinical and drug manufacturing/QA activities. It includes sufficient detail to facilitate project management to the next major milestone. Information on market size and competitive landscape is also included along with financial plans and budget to support valuation modeling which is useful for both investors and potential licensees.

Product development and commercialization is a long and expensive process with many steps and plenty of opportunities to make the wrong decision. In addition to a great plan you need an experienced team to successfully implement the plan. B4D has the experience to manage the project and troubleshoot issues that inevitably arise along the way.