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For Pharmaceutical Ingredient Companies

You sell the most regulated ingredients on earth. Your sales tools should be built for it.

handify is the first platform built for how pharmaceutical ingredient companies actually sell — where every product requires a DMF, every batch needs a COA, every customer audit demands full traceability, and qualification cycles run 12-24 months before the first commercial order.

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If you sell pharmaceutical ingredients, this sounds familiar.

Pharmaceutical ingredient sales teams face regulatory and documentation challenges that generic CRMs were never designed to handle.

Managing DMFs, CEPs, COAs per batch, stability studies, and GMP certificates across your API and excipient portfolio is a full-time job — and a single outdated document during a customer audit can jeopardize a qualification that took 18 months to build.

Qualification cycles run 12-24 months: from initial technical review, through stability studies, regulatory filing, and commercial approval — your CRM tracks none of these milestones, so pipeline visibility is a guessing game.

Customer audits happen frequently and demand instant access to complete traceability — batch records, supplier qualifications, change control history, and regulatory filing status — but this data lives scattered across shared drives, email, and paper files.

The supplier landscape is constantly shifting: regulatory actions, GMP non-compliance findings, and API shortage alerts require your team to react fast — but there's no system connecting supply intelligence to your sales pipeline.

Every pharma customer has different documentation requirements based on their filing (ANDA, NDA, MAA) and target market (FDA, EMA, PMDA) — and your team manually assembles different document packages for every opportunity.

How handify solves this for pharmaceutical ingredient companies

Every feature was designed for the reality of pharmaceutical ingredient sales — not adapted from a SaaS playbook.

Document Automation & Control

Upload DMFs, CEPs, COAs, stability studies, and GMP certificates and let AI extract and map the data automatically. Full version control with audit trail — when any document is revised, the update propagates to every bundle, every client, every shared link. Audit-ready at all times.

Approval Workflows

Route technical reviews, pricing approvals, and qualification milestones through configurable workflows. From initial API assessment to commercial pricing sign-off — every step tracked, every decision documented, every approval timestamped with full audit trail.

Technical Parameters & Specifications

Every API and excipient with its full pharmacopeial profile — USP/EP/JP specifications, particle size, polymorphic form, impurity profiles, stability data — all filterable, searchable, and connected to your sales workflow. Structured data that supports both sales and regulatory teams.

Pharma Qualification Pipeline

A pipeline built for 12-24 month pharmaceutical qualification cycles. Track technical evaluation, stability studies, regulatory filing support, audit readiness, and commercial approval — all alongside your commercial milestones. Full visibility from first sample to first commercial batch.

API & Excipient Catalog

Every pharmaceutical ingredient with its complete regulatory and technical profile — DMF/CEP status, pharmacopeial compliance, GMP certification, approved manufacturing sites, and batch-specific COA history — filterable and searchable. Your entire portfolio, structured for pharma-grade traceability.

Sample & Batch Management

Track every API and excipient sample from request to delivery, linked to specific batches and COAs. Each sample is connected to the account, the qualification project, and the product — with full batch traceability and automatic notifications to your customer.

How do pharma ingredient teams manage sales today?

API/excipient catalog with pharmacopeial and regulatory data

Spreadsheets & Email
Generic CRM
handify

DMF, CEP, and COA management with full version control

Spreadsheets & Email
Generic CRM
handify

Complete audit trail for every document and approval

Spreadsheets & Email
Generic CRM
handify

Configurable qualification and approval workflows

Spreadsheets & Email
Generic CRM
handify

Batch-specific COA tracking linked to samples and shipments

Spreadsheets & Email
Generic CRM
handify

Professional client packages with auto-updating documents

Spreadsheets & Email
Generic CRM
handify

Qualification pipeline with regulatory milestone tracking

Spreadsheets & Email
Generic CRM
handify
“Your pharma customers don't just buy an ingredient — they buy the confidence that comes from complete traceability, audit-ready documentation, and a supplier that understands their regulatory reality. handify gives your team the tools to deliver that confidence at every stage of the qualification cycle.”
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Frequently asked questions

How does handify help manage DMF and CEP documents?

handify centralizes all your Drug Master Files (DMFs) and Certificates of Suitability (CEPs) with full version control and audit trail. Each document is linked to the specific API or excipient it supports, and when a filing is updated or a new version is submitted, the change propagates to every bundle and shared link automatically. Your team always shares the current version, and you maintain a complete document history for audit readiness.

Does handify meet audit trail requirements for pharmaceutical sales?

Yes. handify maintains a complete, timestamped audit trail for every document upload, version change, approval decision, and customer interaction. Every action is logged with user identity, timestamp, and change details — supporting your compliance with FDA 21 CFR Part 11 concepts and EU Annex 11 expectations. When a customer audit team asks for document history or approval records, everything is accessible in seconds, not hours.

How does handify handle GMP compliance documentation?

handify manages your GMP certificates, manufacturing site authorizations, and compliance documents — all linked to the specific products and manufacturing sites they apply to. When a GMP certificate is renewed, every product bundle referencing that site updates automatically. Expiration alerts ensure your team is never caught sharing outdated GMP documentation, and the full certificate history is maintained for traceability.

How does handify help with pharmaceutical qualification cycles?

handify's pharma qualification pipeline is designed for the 12-24 month cycles typical in pharmaceutical ingredient sales. Track every milestone: initial technical assessment, sample evaluation, stability study initiation, regulatory filing support, customer audit, and commercial approval — all in one view. Each stage is connected to the relevant documents, samples, and approvals, so your entire team has visibility into where every qualification stands and what's needed to move it forward.

Does handify handle differences between API and excipient sales?

Yes. While APIs and excipients share similar regulatory frameworks, their sales processes differ significantly — APIs involve DMF referencing, impurity profile discussions, and polymorphic form specifications, while excipients focus on functionality testing, co-processed grades, and formulation compatibility. handify's flexible catalog and pipeline structure accommodates both, with technical parameters and document requirements configurable per product type, so your team handles API and excipient sales with the right level of detail for each.

See how handify works for pharmaceutical ingredient sales

Whether you sell APIs, excipients, or pharmaceutical intermediates — we built this for you.

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