Services

What's New

Environmental Monitoring Programs

TLI Development recently completed an extensive restructuring of an environmental monitoring (EM) program in conjunction with Cleanroom Management.  The program changes followed a major facility renovation to the heating, ventilation, and air conditioning (HVAC) system.  From site selection to HEPA filter integrity testing to establishing an electronic database for rapid monitoring of EM data, we provided a highly integrated package.  Please contact us to learn more about how you can apply these cutting edge principles to your program. 

Our Services

TLI Development provides support in the following areas:

 

- Product development plans and regulatory strategy;

- Regulatory filings such as IND, BLA, NDA, CTD, and ANDA;

- Chemistry, Manufacturing, & Controls (CMC) Data;

- Meetings with FDA, Health Canada, and EU authorities;

- Audits, due diligence reviews, and development program evaluations;

- IND, NDA, and BLA annual reports;

- Comparability Protocols;

- Stability Summaries;

- Labelling & Advertising;

- Reports, Publications, & SOPs;

- Protocols & Clinical Reports;

- Investigator's Brochures; and

- Controlled Substances Audits & Training.

 

The way we work is to establish a confidentiality agreement so that we can discuss your project needs and prepare a project estimate, all free of charge.  Once the deliverables have been confirmed, the client has a firm understanding of the costs and timing.  The client may add a cap to the project estimate in terms of hours or time or break it out into minor milestones; it's very flexible and based entirely on what the client needs and when. 

Once the project estimate is signed, then - and only then - will actual billable hours be applied to the project.  This approach works best for the client since it allows them to fully explore the depth of understanding and level of detail being applied to their project long before they commit any expense.  For more details please contact us.  See the About Us page for details. 

A brief summary of project experience is provided below.

• Regulatory Affairs

Regulatory Affairs projects include ...
 

· NDA (505(b)(2) for a recombinant growth hormone,
· NDA 505(b)(2) for a dopamine antagonist (indicated for anti-emetic & increased GI motility),
· CTD CMC section for a nucleoside analog (indicated for pediatric chemotherapy),
· NDA CMC section for a nucleoside analog (indicated for pediatric chemotherapy),
· IND support for emergency use of plasma derivative,
· BLA CMC section for a plasma derivative (IGIV),
· SUPAC NDA amendments for technology transfers (change of manufacturing sites),
· BLA CMC section for a blood derivative,
· IND CMC section for a recombinant human parathyroid hormone (indicated for osteoporosis),
· IND CMC section for a recombinant human pulmonary surfactant protein (indicated for ARDS/ ALI),
· IND CMC section for a anti-inflammatory drug (MDI indicated for asthma),
· IND CMC section for a purified, unconjugated, monovalent vaccine (for plasma donor immunization),
· IND CMC section for a bivalent, conjugated vaccine (for both active and passive immunization),
· IND CMC section for a leukotriene antagonist drug (indicated for asthma),
· IND CMC section for a polyvalent, conjugated vaccine (indicated for sepsis),

· IND CMC section for a nebulized tartaric acid solution (indicated as a diagnostic aid in stress urinary incontinence),

· IND CMC section for a anti-retroviral vaginal gel (indicated for HIV prevention in 3^rd world countries),

· IND CMC & IMPD CMC section for an anti-inflammatory suppository (indicated for IBS),

· IND for a lyophilized drug (indicated for sepsis),
· IND for a specified intravenous gamma globulin (indicated for cystic fibrosis),
· IND for a specified gamma globulin (indicated for infection in renal dialysis patients),
· IND for an anti-retroviral solid oral dosage form drug (indicated for HIV+/ AIDS),
· NDA CMC section for a solid oral dosage form drug (indicated for erectile dysfunction),
· NDA CMC section for a solid oral dosage form drug (indicated for Alzheimer’s disease),
· ANDA for an injectable controlled substance (Schedule II),
· ANDA for an ophthalmic solution (indicated for reducing IOP),
· ANDA for a topical anti-fungal cream,
· SNDA for a solid oral dosage form drug (indicated for arthritis), and
· PLA for a hepatitis vaccine. 
 

• Medical/Technical Writing

Medical/ Technical Writing projects include ...

· development reports for a solid oral dosage form (indicated for erectile dysfunction),
· development reports for a solid oral dosage form (indicated for Alzheimer’s disease),
· SOPs for format and content of INDs, IND CMC sections, NDA CMC sections, and ELA/ PLAs,
· SOPs for controlled substances compliance and audits,
· informed consents and assents,
· prescribing information,
· analytical methods and validation reports,
· stability protocols or stability summaries,
· clinical protocols or study reports,
· external publications,
· investigator brochures, and
· editor of a pharmacology textbook.

• Quality Assurance

Quality Assurance projects include ...
 

· cGMP audits of both API and finished product facilities (solid oral dosage form & parenteral),