Services
Northpharm is a consulting company that works for Overseas Clients who have experience in the vitamin, Supplement, & nutraceutical manufacturing industry for more than two decades. Our expertise in the areas of product development, manufacturing, quality assurance, R&D, ERP Implementation & support will help deliver the product you desire. We comply with the client’s confidentiality requirements at all times.
Regularity Affairs
North pharm is a global regulatory and technical specialist, that provides end-to-end regulatory and compliance services across lifecycle management from product development (R&D) to registration and post-approval compliance.
In the past few years, we have a proven track record of successfully navigating the evolving regulatory environment across a wide range of innovative therapeutics for quality, speedy, and cost-effective approvals (herbal/nutraceutical)
- Our regulatory intelligence professionals have access to the relevant regulatory agencies and have the expertise to summarize and assess global regulatory intelligence to ensure submissions are compliant with evolving regional and local requirements, reducing the impact of re-work on budgets and timelines.
- There are numerous ways to proceed with each kind of product. Our technical team will study your products upon which we will create a route best fitted for getting approvals of products from Authorities. Our team will predict possible challenges and create a strategy to overcome them.
- Our clients are provided with reliable and accurate global regulatory information to gain competitive advantages and minimize regulatory risks.
Information presented correctly accelerates the timeline and reduces complexities.
Our Quality assurance team audits each document for any errors, updations, or information that is necessary for updated norms, validating them with recent changes or authoritative texts.
Complete plant documentation like SOP, Batch manufacturing records, CTD dossiers, Qualification, validation, etc.
We have Policies, Procedures, Work Instructions, and records (Formats), that describe how to maintain, retain and retire, etc. Standard operating procedures (How to write), Master Batch Record, Batch Manufacturing Record, Quality audit plan, and reports.
Specification and test procedures, Protocols, and reports. Distribution records.
Electronic data handling. Concepts of controlled and uncontrolled documents.
Product dossiers in CTD format as per different country requirements.
Quality Assurance
R& D
Development of different dosage forms and finalization of technical strategy as per regulatory requirements.
Our skilled formulation R & D team is capable of developing various dosage forms by the QbD (Quality by Design) approach and is capable of conducting breakthrough research and overcoming formulation difficulties with Cost-effective product development.
We do the Development of the product in the existing facility up to the advanced stage.
Oral Solid Dosage Form, Liquid Orals, Dry Powder, Gummies, etc.
We guide our clients to work smarter and grow faster using the ERP System in operational excellence approaches that suit their specific needs and situations to improve their business performance against rising competition while reducing costs. We adopt various methods such as Artificial Intelligence and machine learning programs to identify issues, form hypotheses, design and conduct analysis, synthesize conclusions into recommendations, and help to implement change.
Our top ERP technical team helps to maintain the complete process in the industry and our Materials Management
System designed specifically for enterprises. It is an integrated Online solution in a single Box covering all functional areas in materials management such as Materials Requirement Planning, Purchasing, Inventory Control, and Quality Control.
- Value stream mapping exposes waste and bottlenecks in the processes
- The TPM Approach to Manufacturing Excellence
- To increase Overall Equipment Effectiveness (OEE),
- Reducing the Costs of Poor Quality because Poor quality costs a typical company I5-20% of sales annually
- Building an Effective employee Suggestion System
