Raised Pharma takes a product from an idea on paper to a licensed, market-ready dosage form. We work as the development and manufacturing partner for pharmaceutical manufacturers, healthcare brands and supplement companies who need the science, the documentation and the regulatory pathway handled as one piece of work rather than three.
Every programme is designed backwards from its destination. Before a single trial batch is made, we establish which authority will review the file — Health Canada, the FDA, the EMA, or SFDA, EDE, MOPH, NHRA and the GCC-DR route — because the classification, the specification and the evidence expected all follow from that decision.
The target market defines the product. We confirm classification and the expected data package at the outset, so formulation work, specifications and the stability programme are all built to satisfy the file rather than reworked to fit it later.
A formulation that only works once is not a formulation. Development runs with scale-up and technology transfer already in view — process parameters, equipment fit and material specifications documented as we go.
Analytical methods, in-process controls and acceptance criteria are defined alongside the formulation, so quality is a property of the process and not something checked for at the end.
Formulation, sourcing, analytical work, stability, technology transfer, validation and the regulatory submission sit under one team, so nothing is lost in the handover between specialists.
Nine stages. Some programmes need all of them; most need a defined subset. Scope is agreed with you before work begins.
Characterisation of the active — solubility, particle size, polymorphic form, hygroscopicity — and excipient compatibility screening. This is where most late-stage failures are prevented.
Typical deliverables Pre-formulation report, excipient compatibility data, target product profile
More on this service ›Prototype formulations across the chosen dosage form, screened for content uniformity, dissolution, physical stability and manufacturability. Iterated until a robust lead formulation is selected.
Typical deliverables Lead formulation, master formula, trial batch records
More on this service ›Assay, related substances, dissolution and content uniformity methods developed and validated to demonstrate they are specific, accurate, precise and stability-indicating.
Typical deliverables Analytical methods, method validation protocol and report
More on this service ›APIs, excipients and packaging sourced against agreed specifications, with supplier documentation reviewed and audits carried out where the risk profile calls for it.
Typical deliverables Material specifications, CoAs, supplier qualification and audit reports
More on this service ›Long-term, intermediate and accelerated conditions selected against the applicable guideline and climatic zone for the target market, with pull points and test parameters defined in a written protocol.
Typical deliverables Stability protocol, interim and final stability reports, shelf-life justification
More on this service ›Where a study is required, we support the supply side — clinical trial material manufacture, comparator sourcing, placebo matching and stability of clinical batches — working alongside your CRO or bioequivalence partner.
Typical deliverables Clinical trial material, batch documentation, comparator and placebo supply
Discuss this stage ›Process moved from laboratory to production scale, or from a sending site to a receiving site, with parameters, equipment fit, analytical methods and material alignment documented through the transfer.
Typical deliverables Technology transfer protocol, scale-up batch data, method transfer report
More on this service ›Process validation protocols (PVP), execution and reports (PVD, PVR), cleaning validation and the QA documentation set that supports routine commercial manufacture.
Typical deliverables Validation protocols and reports, batch records, release documentation
More on this service ›Dossier compilation and submission support for the target market, and management of queries through to licence, followed by post-market variation support.
Typical deliverables Registration dossier, submission package, query responses
More on this service ›Three dosage-form platforms, developed for pharmaceutical, natural health product and cosmetic applications.
Processes Direct compression, wet and dry granulation, fluid-bed processing, blending, encapsulation, coating.
Processes Solubilisation, homogenisation, viscosity and pH control, microbiological and preservative-efficacy considerations.
Processes Emulsification, phase behaviour, rheology, penetration-enhancer selection, container-closure compatibility.
Moving a validated process without losing it is a discipline of its own. We manage transfer in both directions — laboratory to production, or site to site — covering the documentation package (master formula, batch records, specifications, analytical methods), equipment and facility fit, raw material and vendor alignment, process parameters, trial and validation batches, the stability commitment on the receiving site, and any regulatory notification or variation the move triggers.
Read more ›Process validation protocols and reports, cleaning validation, analytical method validation and the in-process control strategy that sits behind them. We write the protocols to be executed and defended, not to sit in a binder — each acceptance criterion traceable to a specification and each specification traceable to the registered file.
Read more ›API, excipient, packaging and contract manufacturing sites assessed against a structured audit framework: licences, quality management system, GMP compliance, documentation and traceability, materials handling, change control and deviations, sub-contracting and regulatory history — closing with a risk rating and an approve, conditional or reject recommendation.
Read more ›Programmes that have stalled — a failing dissolution profile, a stability signal, a rejected submission, a transfer that will not reproduce at the receiving site. We diagnose against the data, identify the root cause and define the corrective work needed to get the product moving again.
Read more ›A product developed for one market rarely registers unchanged in another. We build the file for the market you are entering.
Please note: this page describes the development, manufacturing and quality services Raised Pharma provides on a contract basis. The exact scope, dosage form, analytical package and regulatory route for any programme are defined and agreed before work begins. Nothing here constitutes regulatory, legal or medical advice, and no submission, label, claim or specification should be filed or used without review by a qualified regulatory professional.