Our Services
GMP Manufacturing
At Medicap Laboratories, our formulation development capabilities are built for precision, speed, and long-term manufacturability. We specialize in oral solid dosage forms including coated/uncoated tablets and capsules designed for scale-up success and regulatory alignment.
Our expert scientists work across pre formulation, prototype design, and process optimization to ensure each product is fit-for-purpose and ready for scale. Using our proprietary platforms like Hypermatrix™, PODRAS™ and nPODDDS™, we develop controlled-release, biphasic, and abuse-deterrent formulations that help differentiate your product and strengthen IP value.
Whether you're targeting complex generics or novel delivery systems, we bring scientific depth and GMP-aligned execution to every formulation we develop.
Packaging Service
We deliver comprehensive, compliant, and scalable packaging solutions crafted to protect your product integrity and amplify your brand presence. Our high speed packaging capabilities are designed to meet the exacting standards, ensuring seamless integration into your supply chain and market strategy. Services we offer:
Primary Packaging: Premium HDPE and PET bottles engineered for compatibility with a broad range of closure and desiccant systems, safeguarding product quality and stability.
Secondary Packaging: Expertly managed cartooning, labeling, tamper evident sealing, bundling, and incorporation of Patient Information Leaflets (PIL) or Instructions for Use (IFU) to ensure regulatory compliance and consumer clarity.
Serialization & Anti-Counterfeit: Cutting-edge 2D barcoding, batch traceability, and QR code solutions that enhance product security and enable robust consumer authentication.
Customization: Bespoke artwork development, brand-aligned design execution, and language-specific regulatory labeling crafted to elevate your product’s market appeal across diverse geographies.
Analytical Services
We offer comprehensive GMP-compliant analytical testing as a standalone service to various clients. Whether you’re a sponsor, development partner, or marketing authorization holder, we provide validated third-party testing aligned with Health Canada, FDA, and ICH standards.
Our Testing Capabilities Include:
- HPLC assay, identification, API impurity profiling and content uniformity
- Residual Solvents testing
- Elemental Impurities Testing
- Analytical Method Development and Validation (ICH Q2)
- Dissolution and Disintegration Testing
- Raw Material and Finished Product Testing
- Stability Studies (Accelerated and Long-term) with Analytical Testing of Finished Products.
We are updating capabilities to add Nitrosamines Testing, Extractables and Leachable Testing, Impurity and Degradation Products Profiling.
Quality Control testing is performed in an on-site laboratory equipped with state of-the-art analytical instruments that comply with 21 CFR Part 11 regulatory requirements using Instruments like
- UV-VIS
- Dissolution Systems (UV-VIS and HPLC)
- FT-IR with ATR
- Powder X-Ray Diffractometer
- HPLC with UV-DAD-ELS detectors (supporting Chiral Analysis)
- GC with FID/MS (Liquid and Headspace injections)
- ICP-MS
- Malvern Particle Size Distribution.
We are also capable of performing USP/EP compendial identification tests, with additional instruments in the pipeline such as HPLC-MS/MS, Polarimeter, and DSC.
We support standalone contracts for routine QC, stability testing programs, and method transfer/validation serving both Canadian and international clients with fast turnaround and validated protocols.
Regulatory Support
Our in-house regulatory affairs team offers specialized support for CTD preparation, filing strategy, and agency communication to help bring your product to market faster and with fewer delays. We support small- to mid-size pharmaceutical companies, global partners, and development-stage innovators seeking compliance clarity and execution.
Key Regulatory Services we offer:
- CTD Module 2 & 3 (CMC authoring for drug substance and drug product
- ANDA / NDA / DIN / 505(b)(2) submissions.
- Canadian DIN and NOC filing support
- DMF preparation (Open & Closed Part)
- IMPD dossiers and EU-ready documentation.
- Health Authority Query Management (IRs, RFIs, deficiency letters.
- Lifecycle Management – Post-Approval Changes & Renewals
- Regulatory Labeling Compliance and Updates
- Inspection Readiness & Data Integrity Consulting
- We stay current with global agency expectations and help you navigate FDA, Health Canada, EMA, and ROW markets confidently.
R&D Innovation
Our R&D capabilities are purpose-built to support your product journey from early formulation to clinical trial readiness and tech transfer. With a deep focus on collaboration, speed, and scientific integrity, we serve as a reliable extension of your team—helping you accelerate development timelines without compromising on quality or compliance.
What We Offer:
Formulation Services: Leverage our patented immediate-release and controlled-release platforms for robust and scalable formulation solutions. We specialize in Solubility enhancement, Stability optimization, Customized release profiles for diverse therapeutic areas.
Pre-Clinical to Clinical Support: From clinical trial material (CTM) development to IND documentation support, we streamline the transition from pre clinical studies to first-in-human trials.
Technology Transfer: Our structured tech transfer protocols ensure seamless knowledge sharing, minimal variability, and reduced downtime, enabling fast, efficient scale-up into commercial manufacturing.
Collaborative R&D: We believe in transparent, IP-safe partnerships. Whether you're seeking co-development or specialized formulation input, our milestone-driven approach and confidential framework provide you with both security and speed.
Medicap is developing an AI powered drug release predictability platform to accelerate R&D by accurate modeling formulation performance early in development. This approach reduces timelines, improves decision-making, and enables proven, outcome - driven development at earlier stages.