Selling a Pharmaceuticals & Biotech Business

From diligence calls we review, pharma and biotech deals move faster when you can prove three things early: what rights actually transfer, what evidence stands up in an audit, and whether your quality system and supply chain hold up under a new owner’s change control.

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What buyers ask and how to be ready

Each topic below comes from real buyer-seller conversations. Here's what they ask, what they're really evaluating, and how to prepare.

Rights & Assets

What exactly are you selling: an asset, a platform, or a regulated operation?

Buyers are clarifying what they are buying in legal and operational terms, such as IP, data, validated methods, QMS (Quality Management System) records, customer contracts, or a regulated facility. They also want to see whether anything blocks transfer, including consents, shared rights, missing deliverables, or registrations that force a restructure after the LOI.

How to prepare

  • Write a one-page “what’s included” list: programs, trademarks, lab notebooks, code, methods, quality records, and customer contracts
  • Create a plain-English rights map: owned vs. licensed-in vs. licensed-out, plus field-of-use and territory limits
  • List change-of-control notices/consents across key contracts, licenses, and registrations

Great Answer

We’re selling a regulated services operation, plus the validated workflows and customer contracts behind it. Here is the inclusions list (SOPs, validation packages, batch and test records, and MSAs), and here is our rights map showing what’s owned vs. licensed and which agreements need consent on change of control. The buyer can take operational control from day one without relying on side agreements.

Okay

It’s mainly the platform and the customer relationships, and we can pull together a complete inclusions list. Some licenses may need consent, but we have not mapped all of them yet.

Gives Pause

You’re buying the company, so everything transfers. We’ll sort out what’s included once we pick a buyer.

How Rejigg helps: Rejigg lets you package the inclusions list and rights map in a structured data room, with staged access for sensitive schedules and records. Learn more in the guide

IP Cleanliness

Who actually owns the invention, and is the IP chain of title clean?

They are checking whether any founder, contractor, university, or collaborator can claim core IP after closing. If the chain of title is unclear, buyers usually protect themselves with escrows, closing conditions, price reductions, or an asset deal that narrows liability.

How to prepare

  • Collect signed invention assignments for every employee and contractor tied to core work
  • Confirm patent and provisional assignments are executed and recorded where needed
  • Summarize joint-development terms: background vs. foreground IP, options, and exclusivity

Great Answer

Every inventor and contractor has signed assignments to the company, and we have an executed trail for each patent family, including recorded assignments where required. We have one university license with a clear field of use and an assignment clause that works with notice. There are no unexercised options or side-letter exclusivity terms.

Okay

We believe the company owns the IP, and we have most assignments, but we still need to clean up a couple early contractor items and confirm any recording steps.

Gives Pause

The founders own the ideas, and everyone understands the company can use them. We don’t have all the paperwork.

How Rejigg helps: Rejigg helps you organize and permission IP diligence materials so buyers can verify chain of title without documents floating around in email. Learn more in the guide

Quality System

Would your work survive a buyer’s audit? How do you run quality day to day?

Buyers look for a QMS that works in practice, including deviations, CAPA (Corrective and Preventive Action), change control, training, supplier qualification, complaints, and release decisions. If they see workarounds or undocumented decision-making, they assume remediation after close, higher compliance risk, and slower integration. That often shows up as a lower price, a holdback, or tougher closing conditions.

How to prepare

  • Prepare a short QMS overview: deviations/CAPA, change control, training, supplier qualification, complaints
  • Compile audit and inspection history with findings, CAPA closure, and effectiveness checks
  • Document governance: who owns QA, and who can block release or shipment

Great Answer

We run an active QMS with defined deviation triage, CAPA ownership, and change control that is used for day-to-day decisions. Here is our audit history, the observations, and closed CAPAs with effectiveness checks. Repeat issues have trended down over the last 18 months, and QA has independent authority to stop release when needed.

Okay

We have SOPs, and we handle deviations and changes, and we can pull audit history. Training records and consistency across teams still need tightening.

Gives Pause

We don’t track deviations formally because we don’t have many issues. Quality is mostly common sense here.

How Rejigg helps: Rejigg keeps QMS evidence in a buyer-friendly structure so diligence stays focused instead of turning into a document hunt. Learn more in the guide

Validation & Transfer

How painful will it be to move or scale what you do? What’s validated versus just used?

They are estimating cost and timeline for integration, including re-validation, retraining, documentation rebuilds, and tech transfer risk for manufacturing, assays, and regulated software. A credible transfer plan lowers the fear that closing triggers months of remediation or a compliance event.

How to prepare

  • Inventory what is validated today (processes, methods, systems) vs. what is only procedural
  • Document what must be repeated for site moves, supplier swaps, and instrument or system changes
  • Summarize prior tech transfers with timelines, issues, and the controls added afterward

Great Answer

We can clearly separate what is fully validated from what is operationally in use but not under formal validation. We mapped what must be repeated under a site transfer, major supplier change, or instrument swap, with realistic timelines and staffing. We also completed a tech transfer last year, and we can show what went wrong, how long it took, and what we changed to reduce repeat risk.

Okay

Some parts are validated, and some are more procedural, and we can outline what we think would need to be redone after a move. We have not written a full transfer plan yet.

Gives Pause

It should be easy to move. We haven’t had to validate much because it works.

How Rejigg helps: Rejigg lets you share validation packages and tech-transfer materials in stages, with NDA gating and folder-level permissions. Learn more in the guide

Regulatory Posture

What lane are you in? What claims can you legally make today, and what’s the next agency interaction?

Buyers want the real regulatory classification, the history of agency interactions, and proof that current claims stay within the label, RUO (Research Use Only), or authorization boundary. They also assess whether a change of control or site move triggers notifications, supplements, re-approvals, or re-validation that affects closing and continuity.

How to prepare

  • Summarize regulatory status by product/program and geography, including submissions, approvals, and commitments
  • Compile agency interactions, written feedback, open actions, and the next expected milestone
  • Document boundaries, including off-label controls, RUO limits, and distribution restrictions

Great Answer

For each program, we have a one-page regulatory status summary by geography, including submissions, open commitments, and the next planned agency interaction. We maintain a claims library with promo-review controls, and we document where we do not make claims or distribute product. We also mapped what a change of control and a site transfer would trigger, so you can see what is notification-only versus what requires additional work.

Okay

We can describe our current status and the next milestone, and we have most agency communications. We still need to formalize the change-of-control implications across geographies.

Gives Pause

We’re compliant and FDA-approved-ish, so we don’t expect issues. Regulatory gets handled as it comes up.

How Rejigg helps: Rejigg helps you present a buyer-ready regulatory packet and control access to sensitive correspondence and submission materials. Learn more in the guide

Data Rights

Can we use the clinical and preclinical data after a change of control, and can we access the raw data?

They are confirming the buyer can rely on your studies for submissions, audits, and partner discussions, including access to underlying datasets. If ownership, access, or assignment terms are unclear across CROs, academic sites, biomarkers, or companion diagnostics, buyers assume they may need to repeat work or renegotiate with third parties.

How to prepare

  • Create a study list showing who ran each study, where raw data sits, and what the contract says about ownership and transfer
  • Collect study reports, data access terms, and audit rights for CRO and academic work
  • Flag third-party dependencies (biomarkers, CDx, proprietary assays) and how continued use is secured

Great Answer

We keep a study register that covers ownership and transfer rights for each critical study, plus raw data location and CRO audit rights. Key CRO and site contracts are assignable on change of control, and we can show that we own the reports and have access to the underlying datasets. For third-party biomarkers and assays, we have documented both the dependency and the contractual path to continued use.

Okay

We have the main reports and know who ran the studies, but we have not summarized assignment and raw data access terms by contract. We can pull that together quickly.

Gives Pause

We have the PDFs and a slide deck. Raw data is with the CRO, and we assume we can get it if needed.

How Rejigg helps: Rejigg lets you organize studies alongside the underlying contracts so buyers can verify reuse rights without weeks of back-and-forth. Learn more in the guide

Supply Continuity

What happens if your CMO fails an inspection or a single-source material disappears?

Buyers are underwriting whether you can keep supplying compliant product, or delivering regulated services, through inspections, capacity constraints, and vendor failures. Single points of failure such as a CMO, API source, cell line, resin, or cold-chain lane can kill a deal or drive tough terms like holdbacks and long transition services.

How to prepare

  • Map the full supply chain: CMO(s), critical suppliers, lead times, and single-source components
  • Confirm quality agreements, change control expectations, and ownership of process and method know-how
  • Build a second-source or tech transfer plan with qualification status and a timeline

Great Answer

We can show a supply chain map with our CMO, critical suppliers, lead times, and single points of failure, plus the quality agreements that govern change control and inspections. We own the process and analytical method packages needed for transfer, and we have a second-source plan with milestones that separate what’s already qualified from what’s still planned. We can also quantify historical batch performance, including deviations, rejects, and how often we see a true out-of-spec event.

Okay

We rely on one main CMO and a few key suppliers, and we have quality agreements, but the backup plan is still in progress. We can outline options and timelines.

Gives Pause

Our CMO is great, so we’re not worried. If something happened, we’d just find another one.

How Rejigg helps: Rejigg gives buyers a structured view of CMO and supplier diligence, while keeping sensitive vendor details permissioned. Learn more in the guide

Concentration Risk

How much revenue is tied to a single program, molecule, or trial outcome?

They are looking at program-level dependency because one readout, enrollment delay, sponsor reprioritization, or lifecycle event can drop volume quickly. Lower concentration and clear redeployability of staff and validated capacity usually leads to better terms and less pressure for earnouts tied to future performance.

How to prepare

  • Map revenue by program, study, and stage, not only by sponsor name
  • Separate ongoing trial work from new starts and model what happens if a program stops
  • Document redeployability: cross-training, bench flexibility, and realistic capacity shift timelines

Great Answer

We break revenue down by sponsor and by program and study stage. No single program is more than 18% of revenue, and our top sponsor spans five programs. If a program stops, we can redeploy staff across validated workflows within defined timelines, and our new-start pipeline is diversified across therapeutic areas.

Okay

We know our top sponsors and which programs drive volume, but we have not built a clean program-level revenue map yet. We can explain redeployment in practical terms.

Gives Pause

We don’t track revenue by program. If a trial ends, we’ll just sell more.

How Rejigg helps: Rejigg helps you show concentration at the program level, which buyers care about in pharma and biotech diligence. Learn more in the guide

Key People

Who holds the license to operate? Who can sign, release, and keep this compliant if leadership changes?

In regulated businesses, key-person risk often comes down to authority and tacit know-how. Buyers look at release signatories, QA leadership, validation owners, principal scientists, and whoever manages the CMO and critical suppliers. They want proof that audits, method execution, and supplier change control do not depend on one person’s memory.

How to prepare

  • Map critical roles to named people: QA authority, release decisions, submissions, and method or process owners
  • Create backup coverage and cross-training for the 2–3 most fragile knowledge areas
  • Document critical workflows so know-how is transferable and auditable

Great Answer

Quality governance and release authority are assigned by role, and each critical signatory role has a documented deputy. For the two most tacit areas, our analytical method and our cold-chain excursion response, we have written procedures and trained backups with observed proficiency. If the buyer keeps the team but changes leadership, we can show what would be stressed first and the controls that keep work compliant.

Okay

We know who the key people are, and we have some documentation, but backups are thin in a couple areas. Retention and a transition period would help de-risk it.

Gives Pause

It’s a small team, so everyone can cover. If someone left, we would hire a replacement.

How Rejigg helps: Rejigg helps you share an org and authority map and a transition plan so retention and handover terms are easier to negotiate. Learn more in the guide

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Questions Pharmaceuticals & Biotech Owners Ask Us

Value usually tracks what a buyer can defend in diligence. Clean IP ownership, transferable data rights, a credible regulatory path, and a resilient CMO and supplier setup often matter as much as current revenue. Services businesses with steady contracts may still price off EBITDA or SDE, while product and platform companies often price off stage and the next proof point, sometimes with milestones. Use Rejigg’s free valuation calculator for a starting range, then adjust for concentration risk, validation workload, and single-source supply exposure.

Most processes land in the 4–9 month range, but timing depends on how clean your IP, data rights, and quality documentation are. LOI-to-close can be 30–90 days when consents are minimal, and the QMS and supply story are well documented. It can run longer when you need third-party consents for university licenses, collaboration agreements, CRO MSAs, or manufacturing registrations. Rejigg keeps buyer outreach, NDA gating, and diligence documents in one place. See the timeline in prepare to sell your business.

It depends on your deal size, how specialized the buyer universe is, and how comfortable you are running a controlled diligence process. Brokers often charge 5–10% and earn their keep by managing outreach and keeping momentum through diligence. If you can handle the process directly, Rejigg gives you buyer discovery, digital NDAs, a secure data room, and side-by-side offer tracking without a success fee. Start at Rejigg and use the Owner’s Guide to keep the process tight.

Sometimes, usually for cash-flowing service businesses with stable earnings and contracts that transfer cleanly. Examples can include certain lab services, quality and compliance services, and niche distribution with predictable margins. Pre-revenue R&D programs, assets that hinge on a clinical readout, or businesses with heavy regulatory uncertainty rarely fit SBA underwriting. Rejigg includes an SBA loan calculator so you can estimate what price a buyer’s cash flow can support and filter for financeable offers.

Asset sales are common when the buyer wants specific IP, data, contracts, or equipment without inheriting unknown entity-level liabilities. Stock sales can be simpler when key permits, registrations, or contracts are hard to assign, or when regulatory continuity and corporate history matter. Structure often comes down to assignability of CRO and CMO contracts, university license terms, tax goals, and known liabilities. Rejigg’s deal tracking helps you compare offers by structure, escrow, and holdback, not only headline price. See negotiate a deal.

Working capital is the net of short-term items needed to run the business at close, such as inventory, receivables, payables, and accrued expenses. In pharma, it gets more technical because inventory is lot-controlled and can carry expiry risk, quarantine status, and cold-chain requirements. Distribution businesses also deal with returns, chargebacks, rebates, and longer receivable cycles with wholesalers or payers. Buyers typically set a working capital target with a post-close true-up. Rejigg’s data room helps you share inventory and AR/AP support during due diligence and closing.

Yes, especially when value hinges on future proof points like trial readouts, regulatory milestones, tech transfer completion, or a handful of customer expansions. They also show up when buyers see concentration risk that could unwind quickly. Earnouts work best when milestones are operationally measurable, data sources are defined, and buyer control is limited so priorities cannot quietly shift. Rejigg’s offer comparison dashboard helps you review earnout terms side by side, including timing, caps, definitions, and reporting. See negotiate a deal.

Start with what buyers usually verify first. That includes financial statements, IP assignments and key license agreements, a regulatory status summary, a study register with ownership and transfer rights, a QMS overview (deviations, CAPA, change control, training), and key CMO and supplier agreements. You do not need to publish everything up front, but you should be able to produce it quickly under NDA. Rejigg’s secure data room supports staged disclosure and buyer NDAs. Use the checklist in prepare to sell your business.

For commercial products, buyers test whether demand holds up under payer behavior. Expect questions on formulary placement, prior authorization friction, gross-to-net, rebate exposure, and what happens as competitors change labels or pricing. They often want to see evidence that utilization tracks clinical value and guideline adoption, not only early-adopter demand. Bring a channel and reimbursement summary, plus any real-world persistence and discontinuation signals you track. In Rejigg, you can keep payer decks permissioned while still showing buyers the materials exist via the data room index.

Confidentiality matters more here because diligence can expose patent strategy, clinical datasets, quality findings, and CMO and supplier details. Most sellers use staged disclosure: teaser first, then NDA, then limited diligence, and deeper release after serious intent. Rejigg supports this workflow with pre-vetted buyers, digital NDAs before access, and folder-level permissions in the data room. That reduces the chance that sensitive documents get forwarded outside your control. Learn more in find your dream buyer.

Consent requirements can slow or reshape a deal, especially for university licenses, collaboration agreements, CRO MSAs, CMO quality agreements, and key distribution relationships. Buyers will ask whether the counterparty has veto rights, whether economics change, and whether there is a termination right tied to change of control. Identify these agreements early, and build a consent plan into your timeline and closing conditions. Rejigg’s data room and deal tracker help you flag consent items and keep a clean log through due diligence and closing.

Tax outcomes depend on structure, where IP sits, and how the purchase price gets allocated. Asset sales can create ordinary income for certain items, while stock sales often lean toward capital gains treatment, but it varies by situation. For IP-heavy businesses, allocation across intangibles, goodwill, inventory, and services can change after-tax proceeds materially. Cross-border licensing and IP holding companies add complexity quickly. Model taxes early with an M&A tax advisor before locking structure in an LOI. Rejigg’s offer comparison view helps you track price, structure, and timing together.

An escrow or holdback sets aside part of the purchase price to cover indemnity claims after closing. In pharma and biotech, buyers often focus on risks that surface later, such as IP ownership gaps, data integrity problems, regulatory exposure, or QMS remediation that shows up during an audit or inspection. Strong documentation and a tight disclosure schedule can reduce both the size and length of the escrow. Rejigg keeps disclosures and supporting evidence organized so you can negotiate from a position of proof. See negotiate a deal.

Buyers look for lot traceability, expiry exposure, storage conditions, and whether reserves reflect returns, chargebacks, and obsolescence. Cold-chain handling and temperature excursion history can change whether inventory is usable and whether it creates a compliance issue. Expect requests for lot-level reports, quarantine and hold procedures, deviation records tied to excursions, and destruction logs. You also need a plain explanation of what is sellable, what is at risk, and how you prevent repeats. Rejigg’s data room is a practical place to share controlled inventory schedules and SOPs during due diligence and closing.

Compare offers on risk-adjusted value and how much you can control. Look at upfront cash, escrow or holdback, milestone definitions, buyer discretion, reporting rights, employment or consulting requirements, and closing conditions tied to consents or remediation. In pharma and biotech, the cleanest path through quality, regulatory, and supply transfer often wins even if headline price is lower. Rejigg’s deal tracking and offer comparison dashboard support side-by-side review so hidden risk does not get missed. See negotiate a deal.

Transitions often run longer in regulated pharma and biotech because the buyer may need support for tech transfer, validation work, QMS harmonization, partner handoffs, and regulatory notifications. Many deals land on 3–12 months of consulting, plus targeted retention for QA, validation, and process owners. Define scope tightly, including what you will do, what “done” looks like, and when responsibility fully transfers. Rejigg’s process guidance helps you plan this early in transitioning after the sale.

Buyers usually separate your value-added margin from pass-through costs like materials, cold-chain, third-party testing, and freight. They will also check how quickly pricing resets when costs move, since delays can crush margin in a long trial or supply cycle. Prepare clean P&Ls showing gross margin drivers, contract language around pass-through, and any lag between cost increases and customer repricing. Document add-backs, and keep them easy to prove. Rejigg can import financials via QuickBooks to populate the data room faster. Start with prepare to sell your business.

Beyond price, focus on exclusivity length, diligence scope and timeline, structure, required consents, escrow and indemnity caps and survival periods, earnout mechanics, and any employment or consulting obligations tied to key people. In regulated businesses, pay close attention to closing conditions tied to quality findings, open CAPAs, inspection outcomes, or supply transfer readiness. Those can become open-ended if they are not defined. Rejigg’s offer tracking keeps key terms visible across buyers so a “high price” LOI does not hide deal-breaking conditions. See negotiate a deal.

Start now with items that tend to create late surprises. Clean up IP chain of title, build a rights and consents map, create a study and data-rights register, and write a buyer-ready QMS summary that includes audit history and CAPA evidence. These take time because you may need signatures, amendments, and third-party responses from universities, CROs, CMOs, or suppliers. Then tighten financial reporting with consistent add-backs and clear pass-through treatment. Rejigg’s guided steps and data room help you build diligence readiness through prepare to sell your business.