Pharma Research & Development (R&D)

• Innovator Companies
• Generic Companies
• Biologics Companies
• Biosimilars Companies
• CRO (Clinical Research Organization)
• CDMO (Contract Development and Manufacturing Organization)
• CMO (Contract Manufacturing Organization)
• Raw Material & Intermediates
• API (Active Pharmaceutical Ingredients)
• Pharma Research & Development (R&D)
• Excipients
• Formulation (Drug/Biologics)
• Packaging Materials
• Medical Devices
• Analytical Labs
• OTC (Over the Counter)
• Cosmetics
• Nutraceutical
• Food/Dietary Supplement
• Veterinary

Pharma Research & Development (R&D)

Pharmaceutical Research & Development (R&D) is the process of discovering, designing, and developing new drugs or improving existing therapies to ensure their safety, efficacy, and quality. R&D must comply with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) standards, ensuring regulatory approval from agencies like the U.S. FDA, EMA, MHRA, PMDA, and WHO.

1. Discovery & Preclinical Research – Identifying new drug candidates through target identification, lead optimization, and in vitro/in vivo testing. Regulatory requirements include compliance with ICH S6 (Preclinical Safety Evaluation), ICH M3 (Nonclinical Safety Studies for Human Trials), and OECD GLP guidelines. Preclinical studies must provide sufficient safety data for Investigational New Drug (IND) applications.
2. Clinical Development (Phases I–III) – Testing the drug in human subjects through clinical trials:

• Phase I: Evaluates safety and pharmacokinetics in a small group of healthy volunteers.
• Phase II: Assesses efficacy and dosage optimization in patients.
• Phase III: Confirms effectiveness, monitors side effects, and compares the drug to standard treatments.

Clinical trials require compliance with ICH E6(R2) GCP, 21 CFR Part 312 (FDA), and EU Clinical Trial Regulation (CTR) 536/2014. Regulatory submissions include Clinical Trial Applications (CTA), IND, and Biologics License Applications (BLA) for biologics.

3. Regulatory Approval & Market Authorization – After successful clinical trials, companies submit a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Marketing Authorization Application (MAA) to obtain regulatory approval. This includes Chemistry, Manufacturing, and Controls (CMC) documentation, stability studies, and risk management plans.
4. Post-Marketing Surveillance & Lifecycle Management – After approval, drugs undergo pharmacovigilance (ICH E2E), periodic safety reporting, and variations management to ensure continued safety and compliance with post-approval regulatory requirements.

Effective R&D regulatory strategies help pharmaceutical companies accelerate drug development while ensuring compliance with international regulatory frameworks, minimizing risks, and facilitating market entry.

Masuu provide expert regulatory consulting, quality management, and compliance services to support pharmaceutical companies throughout the drug research and development (R&D) process. Our solutions help you navigate the complex regulatory landscape from preclinical research to clinical trials and market authorization, ensuring full compliance with global regulatory standards set by health authorities such as the FDA, EMA, MHRA, PMDA, and WHO.

1. Regulatory Consulting – We offer strategic guidance on drug development pathways, Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), and New Drug Applications (NDA). Our experts ensure your preclinical and clinical studies meet the requirements of ICH, FDA 21 CFR, and EMA guidelines, reducing regulatory risks and approval delays.
2. Quality Management Solutions – We help implement Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) standards to ensure compliance across all R&D phases. This includes quality risk management, data integrity assurance, and audit preparedness for regulatory inspections.
3. Compliance Services – We assist with regulatory submissions, dossier preparation (CTD/eCTD), pharmacovigilance compliance (ICH E2E), and post-marketing requirements to ensure smooth market entry and lifecycle management.

With Masuu’s expertise, you can streamline regulatory approvals, maintain compliance, and accelerate drug development while ensuring the safety, efficacy, and quality of your pharmaceutical products.