Product Development

Ceutical Labs has experienced personnel to assist in the development of parenteral dosage forms. We can  develop and fully document the entire production process. Furthermore, we can design your production process to provide the highest yield of finished product. Within this design, we can validate and establish PAT controls for your process.We have developed parenterals, topicals, and oral formulations across most therapeutic classes.

Our Development Team Can:

• Develop and validate analytical techniques for measuring concentrations of active ingredients and excipients

• Establish formulation procedures, precautions and controls that support a wide variety of formulation approaches

• Establish formulation procedures for parenterals, whether aseptically filled or terminally sterilized

• Perform stability studies according to current ICH guidelines in temperature-controlled storage areas to establish product shelf life

• Match drug, excipient and solvent systems with various filtration media to attain maximum compatibility and efficiency

• Establish validation procedures for manufacturing processes

• Evaluate container/closure systems to select those best suited as determined by product compatibility, reconstitution allowance, and batch size

• Establish PAT controls for your process

• Manage the transfer process from pilot batch to full scale production.

Many dosage forms have been developed and produced for both domestic and international markets. As a result, our analytical services include the testing specified in international pharmacopeias. These pharmacopeias include USP, JP, BP, and EP.

Ceutical Labs has experienced personnel to assist in the development of parenteral, topical, and oral dosage forms. We can develop and fully document the entire production process.

We have developed many products across most therapeutic classes.

Our Development Team Can:

• Develop and validate analytical techniques for measuring concentrations of active ingredients and excipients

• Establish formulation procedures, precautions and controls that support a wide variety of formulation approaches

• Establish formulation procedures for parenterals, whether aseptically filled or terminally sterilized

• Perform stability studies according to current ICH guidelines in temperature-controlled storage areas to establish product shelf life

• Match drug, excipient and solvent systems with various filtration media to attain maximum compatibility and efficiency

• Establish validation procedures for manufacturing processes

• Evaluate container/closure systems to select those best suited as determined by product compatibility, reconstitution allowance, and batch size

• Provide for orderly scale-up to full production volume to assure that the product can be manufactured efficiently. Many dosage forms have been developed and produced for both domestic and international markets. As a result, our analytical services include the testing specified in international pharmacopeias.

In today’s world, your website plays a vital role for your company. It can bring you customers, or cost you customers… help your image or hurt your image… help your customers or frustrate them. Success on the Internet is no accident. There are many aspects of your web strategy that need to come together.

From your favorite nephew to Madison Avenue, your choices of online service providers are endless. So is the frustration you’ll experience if you don’t assemble the right team. At Ceutical Labs, we bring all the areas of expertise you need all under one roof, and all focused on your marketplace.

Experience

Our staff consists of seasoned professionals that are the best at what they do. There is no substitute for real world experience. Let’s take your web design, for example.

• Do you really have all the right features in you site that your customers want and need?

• Is your site fast, scaleable, stable and flexible enough to meet your changing needs?

• Is the site designed with sales in mind?

• Do you even know what web strategies are possible?

• Do you know which strategies are best for your business?

• Is your site really secure?

These are just a few of the questions you need answers to… and that’s only about the site design. Then there are questions about the marketing plan, execution of the plan, e-commerce, fulfillment, lead generation, client retention, up-selling, integration with existing plans, the list goes on.

If you are don’t know the answers to all these questions – relax. We do. We’ve helped others become successful on the web, and we can help your company too. From technical expertise to marketing consulting from people that have actually done what you want to do, we’ve got you covered – seamlessly, effectively, successfully covered. And we’ll tailor it to a price you can afford. Now that’s real value.

In addition to our laboratory and regulatory teams, Ceutical Labs has a strong team of accomplished marketing and sales experts, with a strong focus on the marketplaces we serve. From marketing plan creation to channel development to online marketing strategies, our team has a proven track record of success. Let us put our expertise to work for you.

Ceutical Laboratories, Inc. provides general consulting services in Quality Assurance, Quality Control and regulatory submissions, with specific auditing and developmental services in the areas of manufacturing and testing, preclinical and clinical research.

Quality Assurance and regulatory submissions
Preclinical Testing
Manufacturing and Testing
Clinical Research/Technical Writing
Validation Activities
SOP Preparation and Quality Modules

We also are able to provide clinical monitoring and project management services.

Quality Assurance and Regulatory Submissions

• Consultation on domestic and international regulatory strategies for drug products

• Representation of clients to FDA or other regulatory agencies, including meeting preparation and facilitation

• Assistance with technical writing and documentation

• Quality GMP, GLP, ISO and GCP audits

  • Compliance and documentation systems

  • Systems, facilities and process/operations

  • Contractors and suppliers

• Evaluation/development of training systems and training courses in GMPs, GLPs, ISO, and GCPs

• Evaluation and development of SOP’s, policies, work instructions, and specifications to meet cGMP requirements, including the latest FDA guidelines.

• Establishment of Document Control functions within Ceutical Laboratories to save time, space, and money.

Preclinical Testing

• GLP audits

  • Animal facilities and studies

  • Testing laboratories

• Preclinical protocol preparation/review

• Final report preparation/review

• Preparation of all sections of INDs, NDAs

Analytical testing

• Structural chemistry

• Analytical method development/validation

• Primary standard qualification S

Manufacturing and Testing

• GMP audits

  • Preparation audits for pre-approval inspections

  • Supplier audits

  • API and Finished Product manufacturing facilities

  • Manufacturing, testing, labeling and packaging operations

  • Holding and distribution facilities

• Review of batch records, QC testing records, and stability studies.

• Preparation and review of GMP documentation, including master production records, batch records, testing records, stability protocols and reports, development reports, miscellaneous forms, and SOPs.

• Analytical testing-Chemistry

• Microbiology.

Clinical Research/Technical Writing

Ceutical Laboratories, Inc. works with its clients to ensure understanding of objectives and results. All applicable regulatory requirements, including ICH guidelines, are followed when preparing and reviewing clinical documents.

• GCP audits

  • Contract Research Organizations

  • Clinical studies and sites

  • Clinical study reports and data listings

• Clinical Trial Monitoring – Phase 1 through 4

• Development of clinical forms/reporting systems

• Serious Adverse Event reporting/review

• Write Investigator Brochures

• Preparation/review of clinical protocols and study reports

• Clinical document review

• Preparation of clinical sections of INDs, NDAs

• Consultation on clinical supplies and drug shipment issues

• Literature search and review

• Manuscript Preparation

Validation Activities

• Preparation/review of validation protocols and master plans (including equipment, assay, shipping, cleaning, computer, software, and facilities validation)

• Preparation/review of final reports

• Review and compliance assessment of validation packages

• Develop plans to comply with 21 CFR Part 11

SOP Preparation and Quality Modules

• Your facility to meet current cGMP criteria

• Ceutical Labs can manage the entire Document Control process

Ceutical Laboratories is well versed in the manufacture of parenterals, topicals, and orals. Ceutical Laboratories can enhance your company’s market position by offering a variety of products that include

Parenterals

Sterile filled unit dose products
Blow-Fill-Sealed products
Sterile filled ampules
Lyophilized products
Filled syringes

Topicals

Creams
Ointments
Lotions
Sprays

Orals

Soft gels
Capsules
Tablets