GPC-Dienste

End-to-End Pharmaceutical Regulatory Services

Comprehensive registration, dossier management, compliance consulting, and market access support across all major global jurisdictions.

Pharmaceutical Dossier Preparation & Submission

End-to-end creation of CTD/eCTD dossiers plus technical gap analysis aligned with CDSCO, EMA, and USFDA rules — ensuring complete, submission-ready documentation.

Regulatory & Compliance Consulting

Real-time guidance on CDSCO, EMA, and USFDA requirements. Regulatory affairs consulting for the EU, the US, and India with query support management and ad-hoc consultation.

Authorized Local Agent & MAA Support

Regulatory representation for managing authority communication and handling Marketing Authorization Applications – as your legally appointed local agent across multiple jurisdictions.

Pharmaceutical Lifecycle Management

Support for a variety of submissions, renewals, clarifications, and rapid responses to authorities’ dossier comments across all registered markets and post-approval activities.

Manufacturing Site Approval Assistance

Support with GMP documentation, audit readiness, and manufacturing-site approval processes across global agencies – bridging manufacturing operations and regulatory expectations.

Artwork, Labelling & Market Access Strategy

Compliance-driven artwork, labelling, and pack inserts. Strategic planning for regional pharmaceutical market access including import registration and sample import license assistance.

Our Compliance Model

Our End-to-End Regulatory Process

A structured, transparent process from initial product assessment through to ongoing post-approval support and lifecycle management.

Regulatory Assessment

Assess product, formulation, and intended use. Clarify regulatory objectives and target markets.

Pathway Mapping

Map applicable regulatory pathways, define required tests, and outline documentation needed for submission.

Dossier & Submission

End-to-end CTD/eCTD creation, CRO management, study interpretation, and submission to authorities.

Lifecycle Management

Ongoing variations, renewals, authority responses, and post-market surveillance across all registered markets.

Non-clinical GLP Lab Services

Comprehensive Pre-clinical & Non-clinical Laboratory Capabilities

Our two accredited GLP laboratories deliver the full spectrum of non-clinical safety studies, ADME studies, bioanalytical studies, and genetic toxicology studies required for IND-enabling packages – with a zero percent rejection rate.

Toxicology Services

Repeat Dose Toxicology (2 species); Sub-chronic & Chronic Toxicology
Toxicokinetics (integrated with repeat dose studies)
Immunotoxicology: LLNA, Immunotoxicity Assay, Battery (FOB tests)
Neuro Histopathology & Neuro Toxicology Studies
Bioassay & Immunogenicity Analysis

Core Battery Safety Pharmacology

CNS Safety – Battery (FOB tests) & Neurological Safety
Respiratory Safety Pharmacology
Cardiovascular – hERG assay & Cardiovascular Telemetry
GLP Repeat Dose Studies & Genetic Toxicology
Sub-chronic Toxicity Study

ADME & In Vivo Pharmacokinetics

Serial bleed PK in mice & rats; Cassette dosing PK; Infusion PK
Brain-Plasma & tissue distribution; Excretion studies
Plasma Protein Binding; RBC–Plasma Partitioning
Formulation screening; WinNonlin PK parameters; PKPD

Genetic Toxicology

AMES test
In vitro chromosomal aberration & micronucleus test
In vivo micronucleus & chromosomal aberration test
Genotoxicity & Cytotoxicity screening (in vitro/in vivo)
Local Lymph Node Assay (LLNA)

Reproductive & Juvenile Toxicology (DART)

Fertility & Early Embryonic Development – Seg I
Embryofetal Development – Seg II
Pre- & Postnatal Development – Seg III
Juvenile Toxicology Studies; Chronic Toxicology; ADME

Discovery Services

Solubility, Lipophilicity & Chemical Stability
Liver Microsomal, Hepatocyte & Plasma Stability
CYP450 Inhibition, TDI & Phenotyping; PAMPA screening
IC50/EC50 determination; In Vitro Cytotoxicity (Monolayer, 3D, hERG)

Bioanalytical Services

LC-MS/MS based bioanalysis in various matrices
Analytical method development & validation (HPLC & LC-MS/MS)
Dose formulation analysis, stability studies & matrix effect evaluation
Cross-species bioanalytical validation; Metabolite identification

New Approach Methodologies (NAMs)

3D cell culture models & organ-on-a-chip
Patient-derived organoids
Acute systemic toxicity; Carcinogenicity; Eye irritation & Corrosion
Skin irritation, corrosion, absorption, sensitization; Phototoxicity

New Approach Methodologies

Beyond Traditional Testing – NAMs Capabilities

GPC’s laboratories deploy cutting-edge New Approach Methodologies to generate scientifically robust, regulatorily accepted safety data with reduced animal use.

3D Cell Culture Models

Organ-on-a-Chip

Patient-Derived Organoids

Acute Systemic Toxicity

Carcinogenicity

Eye Irritation & Corrosion

Genotoxicity

Phototoxicity

Skin Irritation & Corrosion

Skin Absorption

Skin Sensitization

Pyrotoxicity

Scientific Collaboration

Collaborative Opportunities for Scientific Synergy

GPC’s engagement model is shaped around shared research priorities – data integrity, translational relevance, and regulatory readiness. We foster science-led partnerships rather than transactional outsourcing.

IND-Enabling Package Co-Development

Enable co-development frameworks for IND-enabling packages with mutual scientific and technical oversight, ensuring seamless translation from discovery to regulatory submission.

Study Design & Data Interpretation

Foster scientific discussions around study design, model selection, and data interpretation to enhance pre-clinical robustness and support successful clinical progression.

Joint Technology Validation

Explore joint technology validations – CNS biomarkers, PK/PD correlations, and safety and efficacy models tailored to CNS, metabolic, oncology, and immunology pipelines.

Translational Continuity

Support translational continuity between discovery biology and regulatory toxicology through shared best practices – bridging the gap from bench to clinic.

Bilateral Innovation Grants

Leverage bilateral innovation and research grants to facilitate collaborative pre-clinical programs and technology exchange between research ecosystems.

Knowledge Sharing & Networking

Encourage knowledge-sharing to strengthen pre-clinical–clinical integration, reinforcing science-led partnerships built on open innovation models.

Ready to Accelerate Your Route to Approval?

Speak with our regulatory and non-clinical experts to discuss how GPC can support your pharmaceutical program – from pre-clinical development through global market authorization