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COMPANY DETAILS » Frontage Laboratories, Inc. back to previous page show list

Frontage Laboratories, Inc.

address: China
Frontage Laboratories (Shanghai), Co. Ltd.
13, Lane 67, LiBing Road, Zhangjiang High-Tech,Shanghai, P. R. China (201203)

Frontage Laboratories, Inc.
105 Great Valley Parkway
Malvern, PA 19355
contact: China
Tel: 021-50796566
Fax: 021-50796603
Contact: Fan Jin

Tel.: 610-232-0100
Fax: 610-232-0101
Contact: Dr. Honggang.Bi
E-mail: hbi@frontagelab.

trunover in millions USD: 0
R & D turnover in millions USD: 0
NET profit: 0
year of financial results:
employees: 0

active in China: YES

SFDA approved: NO


Activities engaged in:
Manufacture: NO
Active Pharmaceutical: YES
Ingredients: YES
Western Generics: YES

R & D:
Discovery: YES
Work Up (pilot to production): YES
Analysis: YES
Quality Control: NO
Stability: NO
Batch Release: NO

Clinical trials:
Run/Manage: NO
Data management: NO
Support Labs: NO

Non clinical & preclinical:
Animal Testing: GLP: NO
New materials Safety Assessment: NO
Pharmaceuticals: NO
Agrochemicals: NO
Industrial & Other Chemicals: NO
Non GLP - Discovery ADME: NO

Chemistry-contract manufacture:
Generics: NO
Licensed Drugs: NO

Frontage Laboratories, Inc. is a rapidly expanding pharmaceutical R&D services company located in Malvern, PA and Shanghai, P.R. China. Frontage Laboratories, Inc was founded on April 2001 at New Jersey, USA. In 2004, the company moved to Malvern, PA. With the efforts of all the staffs, the business of company expanding quickly. In 2006, Frontage Laboratories (Shanghai) was founded at Shanghai and a clinical research center for bioequivalence and clinical study was founded at Philadelphia, USA.
They are called on by leading Pharma companies to solve complex development issues and advance their pharmaceutical products through FDA approval. They hope cooperate with Chinese Pharmaceutical company to get their products FDA approval, such as API or generic drug. They also offer a dynamic work environment that considers personal growth and technical skill development as primary resource objectives.
Frontage Laboratories Shanghaicollaborates with our clients in the following areas:
  1. GLP & cGMP Consulting
  2. ANDA Filling Consulting
  3. Generic Drug Development
  4. Pharmaceutical R&D Services
  • Bioanalytical services – bioanalytical method development, validation and sample analysis supporting preclinical pharmacokinetic, toxicokinetic, and clinical pharmacokinetic studies; GLP study reviewed by QA department and non-GLP study reviewed by QC department.
  • Pharmaceutical analysis – method development, validation and testing; drug substance and drug product characterization; excipient/materials compatibility; Identification of impurities; Stability studies, QA reviewed GMP study.
  • Formulation development – formulation and process development of dosage forms; development and preparation of preclinical study dosage forms; Support formulation scale-up, process validation and regular production; integrated formulation R&D services for NCE and generic drugs.
Frontage Laboratories (Shanghai), Inc have experienced management team, experienced scientific staffs, advanced instruments and laboratories in compliance with GMP and GLP. They will provide high quality services to Chinese and world wide customers. They are looking for partnerships in China to develop and manufacture generic pharmaceuticals and help Chinese pharmaceutical company get FDA approval of their products. At the same time, Frontage will also help US pharmaceutical company enter into Chinese market.
GLP&cGMP Consulting
1 Plant audit, evaluation, instruction and recommendation on improvement;
2 Audit and review document system, professional translation;
3 Consulting on improvement for cGMP system in compliance with FDA  requirements;
      ●   Building and Facilities improvement;
      ●   Document system review and modification;
      ●   Validation system;
      ●   Production Process Procedures;
      ●   Quality Assurance System;
      ●   Packaging and Labeling Control;
      ●   Laboratory Control;
      ●   Materials System;
      ●   Production Facilities and Equipments.
Plant audit by experts and evaluation before FDA site inspection;
5 Accompany FDA site inspection and help manufacturer answer questions  about cGMP asked by FDA inspector;
6 GLP & cGMP training;
7 GLP Laboratory Consulting;
8 QA/QC Training (at U.S. A.or Shanghai Lab)
ANDA Filling Consulting
1  Plant audit and evaluation, provide cGMP improvement plan for 
         generic drug production system;
       ●   Building and Facility Improvement
       ●   Document system review and modification
       ●   Validation system
       ●   Production process Validation
       ●   Quality Assurance System
       ●   Packaging and Labeling
       ●   Laboratory System
       ●   Materials System
       ●   Production facilities and Equipments.
2.      Generic Drug R&D and Training;     
3  ANDA document preparation, review and application. Communicate with FDA and help manufacturer prepare supplement materials according to FDA comments;      
4  Organize site audit by experts before FDA inspection and evaluation;
5  Training and instruction on FDA site Inspection;
6  Accompany FDA site inspection and help manufacturer answer questions about cGMP asked by FDA inspector
7  cGMP training;
    8  Professional translation in written and oral; .
    9  Develop standard operation procedures (SOP`s) both in English and Chinese for quality system;.
   10 QA/QC TrainingFrontage U.S.A. lab or Shanghai lab;
   11 U.S. market development for FDA approved generic drug.
Generic Drug Development
1  Bioequivalent Study;
2  Formulation Process Development;
3  Quality Standards Development;
3  Stability Study (Accelerating stability and Long term Stability);
4  Production Process Validation;
  ANDA  filling, application and cGMP Consulting
Pharmaceutical R&D Services
1Bioanalytical Services
   ●    Biological method development and validation to analyze samples in different biological matrices-plasma, urine, blood and tissues;
   ●    GLP studies with full QA review;
   ●    Non-GLP study support available;
   ●    Support Pharmacokinetic studies and metabolism studies for drug discovery;
   ●    Pre-clinical and clinical development;
   ●    Weekly update to clients and additional communication as necessary;
   ●    Study documentation is all in English.
2Pharmaceutical Analysis
 ●   Analytical method development/Validation for API and finished product testing to  support drug development process;
     ●   Drug substance and drug product characterization;
     ●   Excipient/materials compatibility;
     ●   Identification of impurities;
     ●   Stability studies.
3Formulation Development
●  Formulation and process development of dosage forms, specializing in solid dosage forms (tablets, capsules), semi-solid dosage forms (cream,    ointment, gel), oral liquid dosage forms (solution, emulsion,suspension), and injections(lyophilized powder, solution for injection);
●   Development and preparation of preclinical study dosage forms;
●   Support formulation scale-up, process validation and regular production;
●   Integrated formulation R & D services for NCE and generic drugs.
Song Li, Ph.D., founder, President and Chief Scientific Officer
Song Li, Ph.D., founder, President and Chief Scientific Officer of Frontage Laboratories, Inc., has more than 15 years of pharmaceutical industry experience. Dr. Li held senior level management positions at Wyeth-Ayerst and S.L. Pharma Labs, Inc. due to his expertise in analytical chemistry, method development, validation, and regulatory affairs. Dr. Li received his Ph.D. in Analytical Chemistry from McGill University, Canada, in 1992, and did two years post-doctoral research in Pharmacokinetics at the Oncology Department, McGill University. Dr. Li has more than twenty (20) scientific publications covering topics in chiral separations, drug-protein binding, pharmacokinetics, and analytical chemistry. Dr. Li leads numerous technical projects relating to the development of pharmaceutical products.
Ron Connolly Senior Vice President, Development
Ron Connolly, Senior Vice President, Development, is responsible for managing the finished product and API development groups at Frontage Laboratories, as well as additional business development functions. He combines over 15 years of hands-on API and finished product development experiences from Glaxo Smithkline, Aventis, Wyeth, and Flavine North America to lead the development efforts at Frontage. Ron has been involved in 10 FDA inspections in the last 5 years and is called on by clients to provide QA GMP consulting, regulatory guidance, and training for IND, NDA and ANDA development projects and personnel. Ron also has accumulated project and corporate management experience over the last 10 years and has successfully managed numerous API’s and finished dosage form projects through FDA approval and commercial launch in the USA, Europe, China, Taiwan, South America, India, Korea, and Japan. Ron graduated Drexel University with a BS in Chemical Engineering in 1991.
Fan Jin, M.S Vice President Of Operation
Fan Jin, Vice President of Operations in Shanghai Lab, has over 11 years of experience with Pfizer. Fan is responsible for daily operation at Frontage (Shanghai); she currently oversees Pharmaceutical Analysis, Bioanalytical Department and Formulation Department in Shanghai facility. Fan received her M.S. in Chemistry from University of Massachusetts at Boston in 1991, M.S. in Nutritional Biochemistry from Harvard University in 1994. Before joining Frontage, Fan was principle scientist and project leader at Pfizer, successfully led multiple projects with aggressive timelines. Project experience covers from IND to NDA stages. She received several awards for outstanding achievements in successfully leading the analytical project teams. Fan has a broad range of experience in pharmaceutical research and development, quality control and in-depth knowledge of GLP, GMP and regulatory requirements.
Ms. June Xiao Director of Quality Assurance
Ms June Xiao has over 10 years of pharmaceutical experience at Wyeth and Organon in Europe before moving back to China. Ms. Xiao has extensive knowledge and experience in pharmaceutical analysis, quality control, quality assurance and Validation. She has been involved in numerous FDA inspections during her previous work experience. Before join Frontage, she was a Quality Director with a US based Medical Device company in Shanghai. She is currently responsible for all of the quality operations at Frontage laboratory Shanghai. Ms. Xiao graduated from Trinity College Dublin with a BS in Chemistry.
Tony,Chongdong Fu, Ph.D. Director of Formulation Department
Dr. Fu is Director of Formulation Department, Frontage Laboratories (Shanghai) Co., Ltd. Dr. Fu received his Ph.D. in Pharmaceutics from Fudan University in 2000. He had over 10 years of pharmaceutical research & development experience and teaching experience in Pharmaceutics in Second Military Medical University. Before joining Frontage, he had 5 years of pharmaceutical development experience as R & D manager at Bright Future Pharmaceutical Factory in Hong Kong. Dr. Fu is well experienced in formulation and process development, quality specification establishment, production process validation, regulatory affairs and QC operation. He leaded numerous various formulation projects relating to the development of solid (tablets, hard and soft capsules), semi-solid (cream, ointment and gel) and oral liquid (oral solutions, suspensions) dosage forms. Dr. Fu also has more than twenty scientific publications covering topics in pharmaceutics, pharmacokinetics, and pharmaceutical analytical chemistry
Mr. Chris Zhao Director of Pharmaceutical Analysis Department
Mr. Chris Zhao, Director of Pharmaceutical Analysis Department, has more than 13 years of industrial experience from Schering-plough, Bristol-Myers Squibb, Wyeth, and Sandoz. He has extensive experience in development and validation of API and drug product analysis methods, and bioanalytical methods. Before joining Frontage, he was a team leader in Affymax, Inc., responsible for the development and validation of all in-process control analytical methods. He had precipitated in various ANDA and NDA submissions, and involved in several FDA inspections. Chris received his B.S. degree in Chemical Engineering from Tsinghua University in 1989, and M.S. degree in Analytical Chemistry from Seton Hall University in 1993.

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