What Is Pharmaceutical Development?
The coordinated scientific, operational, and regulatory work required to transform a promising compound into an approvable, manufacturable, and marketable product.
Defining the product.
Clarifying the intended indication, patient population, dosage form, and route of administration. Establishing a Target Product Profile (TPP) and Critical Quality Attributes (CQAs).
Generating the data.
Planning and running preclinical toxicology and pharmacology studies. Designing clinical trials to demonstrate safety and efficacy. Developing and validating manufacturing processes and analytical methods.
Building the systems.
Setting up GMP and GCP frameworks, quality management systems, vendor qualification, and supply chains that can support early trials and commercial scale. Installing pharmacovigilance systems and post-market surveillance plans.
Structuring the dossier.
Authoring regulatory documentation (IMPD/IND, CTD Modules 1-5, ASMF/DMF, CEP). Coordinating agency interactions. Preparing market access and HTA dossiers. Planning post-approval variations and lifecycle updates.
Across Every Function
Our preclinical development team designs toxicology and bioequivalence/comparability studies and manages nonclinical CROs. Our clinical development and operations teams write protocols, plan trial strategies, select sites and CROs, coordinate ethics committee submissions, and support conducting studies. Our CMC experts develop drug substance and drug product processes and author CTD Module 3. Our regulatory strategy and operations team selects authorisation pathways, coordinates PIPs and ODD procedures, manages Scientific Advice meetings in close collaboration with the different teams, and oversees submissions across regions. Our quality and compliance specialists design and implement GxP-compliant systems, oversee technology transfer and scale-up activities, oversee qualification and validation processes, conduct audits, qualify vendors, and ensure inspection readiness. Our pharmacovigilance team manages clinical safety reporting, DSURs/PSURs, signal detection, and post-market surveillance. All of these functions work under one lead and one contract.
How We Work
Many sponsors struggle with fragmented developments. Separate vendors for toxicology, trial operations, manufacturing, pharmacovigilance and regulatory advice, ultimately leading to conflicting timelines, inconsistent quality and unclear regulatory narratives. Depending on the project, we coordinate the entire development journey.
The team that designs the development plan is the same team that writes CTD modules, prepares the Scientific Advice briefing, manages the CTA submission, and handles the agency responses. For multi-country submissions and local compliance roles, we coordinate through our offices in Germany, Portugal, the UK/Ireland, and Switzerland, and through regulanet® members and partners in 90+ countries.
The Development Journey
Each development phase introduces specific scientific, regulatory, and operational requirements.
Discovery & Concept
Define TPP and CQAs. Assess regulatory route (centralised vs. national) and orphan/OTC potential. Align early toxicology, clinical, and CMC timelines. Identify HTA evidence requirements for target markets.
Preclinical
Design toxicology and pharmacology programs. Plan bioequivalence or comparability studies. Prototype formulations and processes. Set up initial QMS. Identify key starting materials and impurity risks. Select CROs.
Design & Development
Optimise and scale processes. Validate analytical methods. Develop manufacturing control strategies and design space. Integrate QbD. Prepare for tech transfer and scale-up. Plan clinical trial supply. Design clinical protocols.
Clinical
Manage clinical supply chain. Coordinate trial conduct. Oversee QA/QP release. Compile DSURs and interim reports. Monitor trial performance. Integrate device usability data if applicable.
Submission & Approval
Author and compile CTD Modules 1-5. Prepare ASMF/DMF/CEP dossiers. Coordinate MA applications and Scientific Advice. Respond to agency questions and clock-stops.
Launch & Market Access
Finalise packaging and labelling. Align supply chain with pricing and HTA strategy. Establish post-authorisation PV systems. Prepare RMP documentation. Support distribution and market access submissions.
Post-Market & Lifecycle Management
Manage variations and renewals. Oversee PMS and PSURs. Conduct signal detection. Integrate RWE for new indications or market extensions. Support lifecycle management, product transfers, and due diligence.
Product-Specific Considerations
The scientific and regulatory requirements vary by product type. These differences need to be accounted for early to ensure development plans remain aligned with regulator expectations.
Small Molecules
Control of impurities, nitrosamines, and degradation products. Bioequivalence or BCS-based biowaivers. Scalable synthesis. CEP/ASMF strategies.
Biologics
Comparability, real-time stability, cell bank/viral safety. Glycosylation and charge heterogeneity monitoring. Cold chain logistics. CMO oversight.
ATMPs
Autologous vs. allogeneic workflows. Viral vector validation. Chain-of-identity and decentralised manufacturing. Rapid stability and release testing.
Peptides / Oligonucleotides
Complex solid-phase synthesis and purification. Aggregation and immunogenicity risks. Specialist analytics.
Herbals / Botanicals
Source variability and qualification. Bibliographic evidence (Traditional/Well-Established Use). Full quality dossiers.
Drug-Device Combinations
Integration of usability data and human factors. Extractables/leachables. Article 117 compliance. PK and usability bridging when switching devices.
Depot / LAI Products
In vitro-in vivo correlation. PK bridging across injection sites. Injection site safety. Hybrid approval pathways. Risk-based bridging studies.
Example Projects
Illustrative Example
15-Year Partnership: Novel Release Technology for a Topical NSAID
Led development of a new release technology for a known NSAID. Created and implemented regulatory strategy, engaged with authorities for scientific advice, and provided extensive CMC, nonclinical, and clinical support. Authored and compiled Marketing Authorization Application dossier, managed regulatory review including responses to scientific questions, and supported post-marketing activities. Enabled successful product approval and lifecycle management over a partnership spanning 15 years.
Illustrative Example
Integrated Regulatory Roadmap for a First-in-Class Biologic
Assessed the mode of action to confirm medicinal classification. Developed an EU/US regulatory roadmap incorporating EMA Scientific Advice and FDA Pre-IND meetings. Authored IND and IMPD, managed parallel submissions, and coordinated eCTD publishing. Both submissions were accepted on first pass with aligned development timelines.
Developing a Pharmaceutical Product?
Tell us about your product, where it is in development, and what you need. We will assess the program and outline the practical next steps.
Speak with an ExpertFrequently Asked Questions (FAQ)
When should CMC and clinical planning start?
As soon as the lead candidate and TPP are defined. Early alignment of toxicology, clinical, and CMC plans prevents redesigns and informs the choice of regulatory pathway. Starting CMC late is one of the most common causes of program delay.
What is the practical impact of the new EU pharmaceutical legislation on development?
The new data protection and market exclusivity structure (8+1, extendable to 11 years) ties incentives to launch timing and geographic coverage. The expanded Bolar exemption means generic and biosimilar competitors can prepare earlier. For development teams, this means the commercial strategy must be designed alongside the regulatory strategy from the outset, and launch sequencing across EU markets needs to be factored into the development plan.
How do EU HTA requirements affect clinical trial design?
Since January 2025, Joint Clinical Assessments apply to oncology and ATMPs, complex Medical Device will be impacted in 2026 and additional areas from 2028. Comparator selection, endpoints, and subgroup analyses must satisfy HTA expectations alongside EMA requirements. These are not identical. Designing the evidence package for regulatory approval alone and planning HTA evidence after authorisation typically results in data gaps that are expensive to close.
What types of products do you support?
Small molecules, biologics, ATMPs, peptides and oligonucleotides, herbals, drug-device combinations, and depot/LAI products. The product-specific considerations table on this page outlines the key development differences by type.
What is the difference between pharmaceutical development and CMC?
Pharmaceutical development, as defined in ICH Q8(R2), refers to the scientific understanding and control of product and process design. More broadly, it also includes the regulatory and clinical planning needed to turn a drug concept into an approvable, marketable product. CMC refers specifically to the structured technical content submitted to authorities in CTD Module 3. We support both, strategically and hands-on, from early planning to approval.
Can you manage development across multiple regions?
Yes. We provide integrated strategies covering EU, UK, Switzerland, US, and other markets. Our regulatory teams align data generation, quality standards, and dossier structure to meet the expectations of EMA, MHRA, Swissmedic, FDA, and other authorities. For local submissions and compliance roles, we coordinate through our own offices and regulanet®.