Methods and strategies that have been shown to work!
Drugs include Generics, Opioids, New and innovative pharmaceutical drugs, and Covid-19 therapeutics. Elexes offers the following end-to-end solutions for companies developing such products.
- Regulatory
- Quality
- Clinical
- Product
What we offer
Regulatory
Regulatory approvals are mandatory to legally sell, expand your business by partnering with us to execute end to end approval processes.
- Investigational New Drug Application (IND)
- New Drug Application (NDA)
- OTC drug monograph
- Abbreviated New Drug Application (ANDA)
- Support life cycle management of NDAs, ANDAs and DMFs
- Pre-NDA and Pre-IND meetings
- Breakthrough Therapy Designation
- Orphan Drug Designation
- Regulatory strategy for the product’s life cycle
- International regulatory requirements
- Meeting international compliance requirements
- Revision of plans as guidelines change
- Provide regulatory CMC compliance advice & execution support
Quality
One size does not fit all! We provide customized quality SOPs and forms, and support with implementation to help obtain certifications.
- ISO 9001 certification
- GxP (GMP, GCP, & GLP) compliance
- Designing, implementing and optimizing GxP quality system
- Internal & Supplier audit/ report
- Risk management
- Clean rooms, Containment, Sanitation and Hygiene
- Production, Analysis and other Activities
- Control of Components and Drug
- Product Containers and Closures
- Packing and Labeling Control
- Holding and Distribution
- Quality control-Laboratory controls
- Validations
Product
We help you develop all the product documents needed for getting a regulatory approval based on the target country’s specific requirements.
- Bioequivalence test support
- Bioavailability test support
- Product specific test support
- Protocol reviews
- Report reviews
- Pre-clinical animal testing
- CMC documentation
- Drug Master File (DMF)
- Import and export requirements
- Requirements for all expanded access uses
- Labeling of an investigational new drug
- Information amendments
- Promotion, charging and waivers of investigational drugs
Clinical
To conduct clinical trials for your drugs, you need numerous documentation and clinical trial applications to be filed. We support with:
- Clinical regulatory inputs for products
- Informed Consent Forms
- Investigator's Brochure
- Annual reports
- Protocol amendments
- Risk-benefit analysis
- Strategy for IND Submission
- Compilation of an IND submission
- Phase I-IV clinical protocol development support
- Clinical trial support for drugs
- Clinical gap analyses
- Project Management
- Support to ensure readiness for Phase I to IV clinical studies
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